Clinical Insights: February 14, 2024

Clinical Insights: March 6, 2024

Clinical Insights: February 29, 2024

Welcome to Pillr Health’s Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace.

New Drug/Vaccine Approval

Amtagvi™ (lifileucel) Suspension for Intravenous Infusion –New Orphan Drug Approval  –February 16, 2024 – The U.S. Food and Drug Administration approved Amtagvi™ (lifileucel), the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor). <Read More>  Aurlumyn™ (iloprost) Injection – New Orphan Drug Approval – February 13, 2024 – The U.S. Food and Drug Administration approved Aurlumyn™ (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. “This approval provides patients with the first-ever treatment option for severe frostbite,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. “Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes.” <Read More>

New Indication/Dosage/Formulation Approval

Biktarvy® (bictegravir, emtricitabine and tenofovir alafenamide) Tablets – New Label Expansion – February 23, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) announced the U.S. Food and Drug Administration (FDA) approved a new, expanded indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat people with HIV (PWH) who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance. HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH. The M184V/I resistance mutation has been found to be present in a range (22-63%) of PWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes. <Read More> Imbruvica® (ibrutinib) Capsules, Tablets and Oral Suspension – New Label Expansion – February 22, 2024 – Johnson & Johnson, in collaboration with its alliance partner, Pharmacyclics LLC, an AbbVie Company, announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Imbruvica® (ibrutinib) with an oral suspension formulation for adult patients in the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); Waldenström’s macroglobulinemia (WM); and chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. “Some patients may have trouble swallowing medications, adding another layer of complexity to their treatment journey,” said Lisa Nodzon, PhD, ARNP, AOCNP at Moffitt Cancer Center. “Having multiple formulations of Imbruvica® offers prescribers another option when treating adults with CLL/SLL, WM, or cGVHD, which could make a difference in their daily lives.” <Read More> Tecvayli® (teclistamab-cqyv) Injection – New Label Expansion – February 20, 2024 – Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Tecvayli® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR) or better for a minimum of six months.1There is a continued unmet need for patients with multiple myeloma and this approval allows increased flexibility in dosing schedule for appropriate patients with a weight-based regimen. <Read More> Xolair® (omalizumab) Injection – New Label Expansion – February 16, 2024 – The U.S. Food and Drug Administration approved Xolairâ (omalizumab) injection for immunoglobulin E-mediated food allergy in certain adults and children 1 year or older for the reduction of allergic reactions (Type I), including reducing the risk of anaphylaxis, that may occur with accidental exposure to one or more foods. Patients who take Xolair® must continue to avoid foods they are allergic to. Xolair® is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis. Xolair® was originally approved in 2003 for the treatment of moderate to severe persistent allergic asthma in certain patients. Xolair® is also approved to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps in certain patients. <Read More> Tagrisso® (osimertinib) Tablets – New Label Expansion – February 16, 2024 – AstraZeneca’s Tagrisso® has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The approval following a Priority Review by the Food and Drug Administration (FDA) was based on the results from the FLAURA2 Phase III trial published in The New England Journal of Medicine. Tagrisso® with the addition of chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso® monotherapy which is the 1st-line global standard of care (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001). Median progression-free survival (PFS) by investigator assessment was 25.5 months for patients treated with Tagrisso® plus chemotherapy, an 8.8-month improvement versus Tagrisso® monotherapy (16.7 months). <Read More> Tepmetko® (tepotinib) Tablets – New Label Expansion – February 15, 2024 – The Food and Drug Administration granted traditional approval to tepotinib (Tepmetko®, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Tepotinib was previously granted accelerated approval for this indication on February 3, 2021, based on initial overall response rate (ORR) and duration of response (DOR) in the VISION trial (NCT02864992), a multicenter, non-randomized, open-label, multicohort study. <Read More> Onivyde® (irinotecan liposomal) Injection – New label Expansion – February 13, 2024 – Ipsen (Euronext: IPN; ADR: IPSEY) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde® regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde® plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy. <Read More>

New Drug Shortage

February 28, 2024

February 23, 2024

February 14, 2024

February 13, 2024

Updated Drug Shortage

February 27, 2024

February 26, 2024

February 23, 2024

February 22, 2024

February 21, 2024

New Drug Recall and Safety Alerts

Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, Lubricant PM Ointment by Brassica Pharma Pvt. Ltd. – New Voluntary Recall – February 22, 2024 - Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration date ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food and Drug Administration (FDA). <Read More>

New Generic/Biosimilar Approval and Launch

Simlandi™ (adalimumab-ryvk) Injection – New Biosimilar Approval – February 23, 2024 – Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced that the U.S. Food and Drug Administration (FDA) has approved Simlandi™ (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira®, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. In 2023, Humira® was one of the highest-grossing pharmaceutical products in the world, with sales in the U.S. of nearly $12.2 billion. Teva is Alvotech’s strategic partner for the exclusive commercialization of Simlandi™ in the United States. <Read More>

Clinical and Pharmacy News

Local Pharmacy Feeling Impact of Nationwide Cyberattack – February 27, 2024 – Pharmacies across the nation and in St. Joseph are working to fill essential medications after a cyberattack last Wednesday disrupted data transmission lines between insurance companies and pharmacies. The cybersecurity attack that took place on a major health tech platform, Change Healthcare, has complicated the process of billing through insurance companies, and local pharmacies are feeling the impact. JulieMarie Nickelson, a registered pharmacist at Roger’s Pharmacy, said when the cyber issue first happened, they experienced nearly 500 claims a day not going through for patients. “It’s improved since last Wednesday, but it’s definitely not resolved yet,” Nickelson said. There are many coupons that aren’t working; we have insurances where some claims are going through, but not others. So, we’re kind of at the mercy of what we call a ‘switch program,’ which is basically the intermediary between the pharmacy and the insurance company.” <Read More> The Change Healthcare Cyberattack is Still Impacting Pharmacies. It’s a Bigger Deal Than You Think – February 26, 2024 - Pharmacies across the United States are still grappling with substantial disruptions following a cyberattack on UnitedHealth’s technology unit, Change Healthcare, as reported by multiple pharmacy chains through official statements and on various social media platforms. The attack led to a nationwide outage of a network designed to communicate data between healthcare providers and insurance companies. According to a filing last Thursday with the Securities and Exchange Commission (SEC), UnitedHealth discovered a “suspected nation-state associated cyber security threat actor” had access to subsidiary Change Healthcare’s systems on Wednesday. <Read More> From Billionaire Mark Cuban to Independent Store Owners, Criticism for Pharmacy Benefit Managers is Plentiful – February 25, 2024 – At first glance, billionaire entrepreneur Mark Cuban may seem to have little in common with an independent pharmacy owner. But they have one shared adversary: pharmacy benefit managers. They claim the drug price negotiators are putting mom-and-pop drugstores out of business. Pharmacy benefit managers — known as PBMs — are third-­party intermediaries between drug manufacturers and insurance providers. PBMs reimburse pharmacies for the prescriptions customers buy with insurance, but independent pharmacy owners accuse them of reimbursing far less than the actual cost of medications. <Read More> AI May Not Be So Smart When Payors Use It To Deny Medical Claims – February 23, 2024 – Concerns are growing about the increasing use of artificial intelligence to review—and in many cases deny—healthcare claims, sparking a congressional inquiry and lawsuits. Thirty-two legislators sent a letter to the Centers for Medicare & Medicaid Services (CMS) on Nov. 3, 2023, urging increased oversight of the use of these tools in Medicare Advantage (MA) plans. “In recent years, problems posed by prior authorization [PA] have been exacerbated by MA plans’ increasing use of AI or algorithmic software to assist in their coverage determinations in certain care settings, including inpatient hospital, skilled nursing facilities and home health,” wrote the representatives, led by Judy Chu (D-Calif.) and Jerrold Nadler (D-N.Y.). <Read More> Taking Pharmacogenomics Guidelines to Heart – February 23, 2024 – Pharmacogenomics is a rapidly expanding field with new evidence and implications for cardiology practice, experts said during the ASHP 2023 Midyear Clinical Meeting & Exhibition, in Anaheim, Calif. Pharmacogenomics (also known as pharmacogenetics) explores how a person’s genes metabolize medications. The Clinical Pharmacogenetics Implementation Consortium (CPIC) has compiled information about nearly 200 drug–gene associations, many in common cardiology drug classes such as antiarrhythmics, antiplatelet/anticoagulants, beta-blockers and statins, said Jordan Baye, PharmD, MA, BCPS, an assistant professor of pharmacy practice at South Dakota State University, in Brookings. <Read More> FDA Revises EUA for Paxlovid™ – February 21, 2024 – The FDA announced a revision to the emergency use authorization (EUA) for nirmatrelvir+ritonavir (Paxlovid™, Pfizer): Nirmatrelvir+ritonavir manufactured and labeled in accordance with the EUA currently in U.S. distribution will remain authorized for use through the labeled or extended expiration date, as applicable, or through March 8, 2024, whichever is earlier. EUA-labeled nirmatrelvir+ritonavir will no longer be authorized for emergency use after March 8, regardless of the labeled or extended expiration date. However, the nirmatrelvir+ritonavir EUA will continue to authorize emergency use of nirmatrelvir+ritonavir manufactured and labeled in accordance with the new drug application (NDA-labeled nirmatrelvir+ritonavir) for the treatment of mild to moderate COVID-19 in pediatric patients (>12 years of age weighing >40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. <Read More> Medication Safety Tools, Pharmacy Technician Usage Up – February 20, 2024 – Health-system pharmacies’ use of technology to improve medication safety and to promote cleanroom compliance has risen, while other metrics such as pharmacist prescribing have remained relatively flat, according to results of the 2023 ASHP National Survey of Hospital Pharmacy Practice. There has been limited change from 2020 to 2023 in pharmacists’ ability to independently prescribe medications pursuant to a diagnosis, said Michael Ganio, PharmD, the senior director of pharmacy practice and quality at ASHP. One of five areas of focus through ASHP’s Practice Advancement Initiative (PAI) 2030—a list of recommendations to advance healthcare and pharmacy practice—was to increase authority for pharmacists to independently prescribe medications by 20% by 2024, he noted during a session at the ASHP 2023 Midyear Clinical Meeting & Exhibition, in Anaheim, Calif. <Read More> Medicare Now Negotiating Price of Drug That Costs $7,100 in US Vs. $900 in Canada – February 6, 2024 – Sen. Bernie Sanders is once again taking the pharmaceutical industry to task, issuing a report Tuesday that highlights the cost of three blockbuster drugs that are far pricier in the US than in other countries. The differences are striking. The annual list price of Bristol Myers Squibb’s Eliquis®, a blood thinner that reduces the risk of stroke, is $7,100 in the US. But in Japan, it’s $940; in Canada, it’s $900; in Germany, it’s $770; in the United Kingdom, it’s $760; and in France, it’s $650. <Read More>

340B in the News

The 340B Hospital Overcharge Controversy: Unveiling the Need for Transparency and Regulation in Healthcare – February 20, 2024 – In a distressing revelation, Adventist Health System, a 340B hospital, has raised serious allegations against some of the world's largest pharmaceutical companies. The hospital claims to have been drastically overcharged by these pharmaceutical giants in a federal drug discount program. This has sparked a wave of concerns about the fairness and transparency of the program and its impact on healthcare providers and patients alike. The allegations revolve around the intricate calculations used to provide medicines to the 340B program. This program necessitates drug manufacturers to offer discounts on all outpatient drugs used by hospitals and clinics primarily serving lower-income patients. In the United States, approximately 12,400 hospitals and clinics participate in this program. These numbers have expanded over the years, making it a substantial market for pharmaceutical companies. <Read More>

 

Alabama Health System Sues Humana to Recoup MA Payments After 340B Rate Revision – February 13, 2024 - Baptist Health has filed a lawsuit against Humana arguing the payer’s Medicare Advantage plans had underpaid for outpatient drugs purchased through the 340B Drug Pricing Program in light of a 2022 Supreme Court decision that amended rates set by the federal government. In 2018, the Department of Health and Human Services (HHS) cut outpatient drug payments to hospitals participating in the pricing program, which requires drug manufacturers to sell drugs at a discount to safety-net providers, by nearly 30%. The Supreme Court ruled the cut unlawful in 2022, leading HHS to issue a one-time lump sum repayment of about $9 billion to impacted hospitals across the nation. <Read More>


Clinical Insights: October 22nd, 2025

New Drug/Vaccine Approval

Jascayd® (nerandomilast) Tablets – New Drug Approval – October 7, 2025 -The U.S. Food and Drug Administration (FDA) approved Jascayd® (nerandomilast) tablets to treat idiopathic pulmonary fibrosis (IPF), a rare, serious, and progressive disease with no cure and limited treatments. This is the first new therapy approved in more than 10 years for IPF. <Read More>

Lasix® ONYU (furosemide) Injection – New Drug Approval – October 7, 2025 - Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) announced that its partner SQ Innovation Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Lasix® ONYU (furosemide injection), a novel drug-device combination for the treatment of edema (due to fluid overload) in adult patients with chronic heart failure. Lasix® ONYU can be administered subcutaneously outside the healthcare setting for selected patients, as prescribed by a clinician, without the need for a healthcare professional to administer the drug. <Read More> 

Rhapsido® (remibrutinib) Tablets – New Drug Approval – September 30, 2025 - Novartis announced that Rhapsido® (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Rhapsido® is a pill taken twice daily and does not require injections or lab monitoring. It is the first FDA-approved Bruton’s tyrosine kinase inhibitor (BTKi) for CSU. Rhapsido® helps to inhibit the release of histamine and other proinflammatory mediators by targeting BTK, offering a unique approach to CSU treatment. <Read More> 

Qivigy® (immune globulin intravenous, human-kthm) Solution for Infusion – New Drug Approval – September 26, 2025 - Kedrion Biopharma announced that it has received FDA approval for Qivigy® immune globulin intravenous (human)-kthm 10% liquid, indicated for treatment of adults with primary humoral immunodeficiency (PI)—a serious and often underdiagnosed group of disorders that compromise the immune system’s ability to function effectively. Qivigy® a 10% IVIG therapy, developed in Kedrion’s research labs and produced exclusively by Kedrion through its globally integrated network of facilities in the United States and Italy, addresses the unmet needs of patients with PI. <Read More> 

Clotic® (clotrimazole) Otic Solution – New Drug Approval – September 26, 2025 - Salvat Pharmaceutical Group has announced that the U.S. Food and Drug Administration (FDA) has approved 1% otic clotrimazole, the first targeted treatment for otomycosis, for commercialization in the United States. <Read More> 

Inluriyo™ (imlunestrant) Tablets – New Drug Approval – September 25, 2025 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Inluriyo™ (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET). <Read More> 

Palsonify™ (paltusotine) Tablets – New Drug Approval – September 25, 2025 - Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) announced that the U.S. Food and Drug Administration (FDA) approved Palsonify™ (paltusotine) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Palsonify™, a selectively-targeted somatostatin receptor type 2 nonpeptide (SST2) agonist, is now the first once-daily, oral treatment approved for adults with acromegaly. <Read More> 

Bondlido™ (lidocaine) Topical System – New Drug Approval – September 25, 2025 - MEDRx announced that the U.S. Food and Drug Administration (FDA) has approved “Bondlido™”, a lidocaine patch MEDRx Group and D. Western Therapeutics Institute, Inc. has jointly developed, in adults for relief of pain associated with post-herpetic neuralgia (PHN). Going forward, preparations for the launch will be made, including the selection of sales partners, with sales planned to begin in the US in the first half of 2026. <Read More> 

Forzinity™ (elamipretide hydrochloride) Injection – New Drug Approval – September 19, 2025 - Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a commercial-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Forzinity™ (elamipretide) injection to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kilograms (kg) (approximately 66 pounds). Barth syndrome is a life-limiting pediatric mitochondrial cardioskeletal disease that affects approximately 150 individuals in the United States. <Read More> 

Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) Injection – New Drug Approval – September 19, 2025 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for Keytruda® (pembrolizumab). Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc. Keytruda Qlex™ must be administered by a health care provider (HCP). Merck expects to have Keytruda Qlex™ (pronounced key-TRUE-duh Q-lex) available in the U.S. in late September. <Read More> 

Subvenite® (lamotrigine) Oral Suspension – New Drug Approval – September 16, 2025 - OWP Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Subvenite® Oral Suspension, the first and only lamotrigine oral suspension in the United States. This innovative formulation will offer treatment options for patients and healthcare providers by offering a flexible, patient-friendly alternative to tablets. <Read More> 

Enbumyst™ (bumetanide) Nasal Spray – New Drug Approval – September 15, 2025 - Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiovascular and renal disease, announced that the U.S. Food and Drug Administration (FDA) has approved Enbumyst™ (bumetanide nasal spray). Enbumyst™ is indicated for the treatment of edema associated with congestive heart failure (CHF), and hepatic and renal disease, including nephrotic syndrome in adults. <Read More> 

Inlexzo™ (gemcitabine) intravesical system - formerly TAR-200 – New Drug Approval – September 9, 2025 - Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved Inlexzo™ (gemcitabine intravesical system), a new, potentially practice-changing approach for treating patients with certain types of bladder cancer, addressing the need for additional options following unsuccessful BCG therapy and for patients refusing or ineligible for bladder removal surgery (radical cystectomy). Inlexzo™, previously referred to as TAR-200, is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. <Read More> 

New Label Expansions

Tezspire® (tezepelumab-ekko) Injection – New Label Expansion – October 17, 2025 - Amgen (NASDAQ:AMGN) and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) approved Tezspire® (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older. Tezspire® is the first and only biologic approved for CRSwNP that targets thymic stromal lymphopoietin (TSLP). <Read More> 

Rinvoq® (upadacitinib) Extended-Release Tablets – New Label Expansion – October 10, 2025 - AbbVie (NYSE: ABBV) announced the U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) that updates the indication statement for Rinvoq® (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD). <Read More> 

Uzedy® (risperidone) Extended-Release Injectable Suspension – New Label Expansion – October 10, 2025 - Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), announced that the U.S. Food and Drug Administration (FDA) has approved Uzedy® (risperidone) as a once-monthly extended-release injectable suspension as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder (BD-I) in adults. <Read More> 

Libtayo® (cemiplimab-rwlc) Injection – New Label Expansion – October 8, 2025 - Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. The FDA evaluated Libtayo® under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the treatment of serious conditions. An additional regulatory application is also under review in the European Union, with a decision expected by the first half of 2026. <Read More> 

Simponi® (golimumab) Injection – New Label Expansion – October 7, 2025 - Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Simponi® (golimumab) for the treatment of children living with moderately to severely active ulcerative colitis (UC), weighing at least 15 kg. This approval builds on the Simponi® indication for adults living with moderately to severely active UC, which together represents more than one million Americans living with this condition. <Read More> 

Zoryve® (roflumilast) Cream and Foam – New Label Expansion – October 4, 2025 - Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company dedicated to developing meaningful innovations in immuno-dermatology, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Zoryve® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age. <Read More> 

Zepzelca® (lurbinectedin) Injection – New Label Expansion – October 2, 2025 - Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) has granted approval for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza®) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The approval marks the first combination therapy for first-line maintenance treatment of ES-SCLC, a fast-growing and aggressive cancer with limited treatment options. <Read More> 

Tremfya® (guselkumab) Injection – New Label Expansion – September 26, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya® (guselkumab) for the treatment of children six years and older who also weigh at least 40 kg with moderate to severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA). <Read More>  

Evkeeza® (evinacumab-dgnb) Injection – New Label Expansion – September 26, 2025 - Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved Evkeeza® (evinacumab-dgnb) ANGPTL3 antibody as an adjunct to diet and exercise and other lipid-lowering therapies for the treatment of children from age 1 to less than 5 years old with homozygous familial hypercholesterolemia (HoFH). Evkeeza® was initially approved in 2021 for adults and adolescents aged 12 years and older with HoFH based on a placebo-controlled trial showing Evkeeza®, when added to standard lipid-lowering therapies, could lower LDL-C by about 50% compared to placebo in this high unmet need population. <Read More> 

Tremfya® (guselkumab) Injection – New Label Expansion – September 19, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). With this approval, Tremfya® is the first and only IL-23 inhibitor to offer both SC and intravenous (IV) induction options for the treatment of UC and Crohn’s disease (CD), which combined affect approximately three million Americans. <Read More> 

Opzelura® (ruxolitinib) Cream – New Label Expansion – September 18, 2025 - Incyte (Nasdaq: INCY) announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura® (ruxolitinib) cream 1.5%, a topical Janus kinase (JAK) inhibitor, for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised children two years of age and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not recommended. <Read More> 

Vyjuvek® (beremagene geperpavec-svdt) Topical Gel – New Label Expansion – September 12, 2025 - Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced that the United States Food and Drug Administration (FDA) approved a label update for Vyjuvek® (beremagene geperpavec-svdt) that expands the Vyjuvek® eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibility with respect to Vyjuvek® application and managing wound dressings. <Read More> 

Koselugo® (selumetinib) Capsules and Oral Granules – New Label Expansion – September 10, 2025 - The Food and Drug Administration approved selumetinib (Koselugo®, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN. <Read More> 

Vonvendi® (von willebrand factor (recombinant)) for Injection– New Label Expansion – September 5, 2025 - Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Vonvendi® [von Willebrand factor (Recombinant)], expanding the indication to include routine prophylaxis to reduce the frequency of bleeding episodes in adults with von Willebrand Disease (VWD), including those with Type 1 and 2 disease, and on-demand and perioperative management of bleeding in pediatric patients with VWD. Vonvendi® was previously approved for on-demand and perioperative use in adults with VWD and routine prophylactic use in adults with severe Type 3 VWD receiving on-demand therapy. <Read More> 

New Drug Shortage

October 20, 2025

October 17, 2025

October 16, 2025

October 10, 2025

October 09, 2025

Updated Drug Shortage

October 17, 2025

October 16, 2025

October 15, 2025

October 10, 2025

October 09, 2025

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Eydenzelt® (aflibercept-boav) Injection- New Eyleaâ Biosimilar Approval – October 9, 2025 - Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Eydenzelt® (aflibercept-boav), biosimilar referencing Eylea® (aflibercept), for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR). <Read More> 

Enoby™ (denosumab-qbde) Injection - New Proliaâ Biosimilar Approval – September 26, 2025 - Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announce that the U.S. Food and Drug Administration (FDA) has granted approval for the Biologics License Applications (BLA) of their biosimilar denosumab products, EnobyTM (denosumab-qbde) and XtrenboTM (denosumab-qbde), referencing Prolia® and Xgeva® respectively. <Read More> 

Xtrenbo™ (denosumab-qbde) Injection - New Xvega® Biosimilar Approval – September 26, 2025 - Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announce that the U.S. Food and Drug Administration (FDA) has granted approval for the Biologics License Applications (BLA) of their biosimilar denosumab products, Enoby™ (denosumab-qbde) and Xtrenbo™ (denosumab-qbde), referencing Prolia® and Xgeva® respectively. <Read More> 

Aukelso (denosumab-kyqq) Injection - New Xvega® Biosimilar Approval – September 16, 2025 - – Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Bosaya™ (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single dose prefilled syringe (PFS), and Aukelso™ (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial, biosimilars of Prolia® and Xgeva® respectively. In addition, the U.S. FDA granted provisional interchangeability designation for both Bosaya™ and Aukelso™. <Read More> 

Bosaya™ (denosumab-kyqq) Injection – New Proliaâ Biosimilar Approval – September 16, 2025 - Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Bosaya™ (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single dose prefilled syringe (PFS), and Aukelso™ (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial, biosimilars of Prolia® and Xgeva® respectively. In addition, the U.S. FDA granted provisional interchangeability designation for both Bosaya™ and Aukelso™. <Read More> 

Clinical and Pharmacy News

Pharmacy Profession Unites to Publish Guiding Principles for State Policy on Pharmacy Personnel-Administered Vaccines – October 16, 2025 –The Pharmacy-based Vaccine Access Work Group, consisting of representatives from a diverse group of 12 organizations across pharmacy practice settings, jointly published guiding principles for state policy on pharmacy personnel–administered vaccines. This marks an unprecedented level of collaboration between pharmacy professionals, symbolizing a strong commitment from the field of pharmacy to national public health interests. <Read More> 

WHO Warns of Widespread Resistance to Common Antibiotics Worldwide – October 13, 2025 – One in six laboratory-confirmed bacterial infections causing common infections in people worldwide in 2023 were resistant to antibiotic treatments, according to a new World Health Organization (WHO) report launched today. Between 2018 and 2023, antibiotic resistance rose in over 40% of the pathogen-antibiotic combinations monitored, with an average annual increase of 5–15%. Data reported to the WHO Global Antimicrobial Resistance and Use Surveillance System (GLASS) from over 100 countries cautions that increasing resistance to essential antibiotics poses a growing threat to global health. <Read More> 

Why Pharmacist Burnout is a Patient Safety Issue – October 5, 2025 – Behind every prescription safely dispensed stands a pharmacist making dozens of clinical decisions under mounting pressure. What happens when that pressure becomes unbearable? When the professionals who are the last line of defense against medication harm are pushed to their breaking point, patient safety breaks with them. This crisis is real and it is often invisible. Surveys and workplace reports repeatedly show that large numbers of pharmacists experience burnout and consider leaving the profession. Unlike physician burnout, which has received public attention and resources, pharmacist burnout remains under-recognized by many health care leaders and policymakers. <Read More> 

Pharmacist-Led Community Health Interventions Provide Practical, Effective Treatment for Older Adults – October 3, 2025 – Through community health interventions geared toward older adult populations, clinical pharmacists proved their ability to provide practical and effective guidance on managing patients’ medications and chronic diseases, according to findings from a study published in Pharmacy. Despite the need for further research to understand its long-term impacts, preliminary results from the researchers’ Pharm2Home initiative were significantly promising and could serve as a precursor for the development of more pharmacist-led clinical services. <Read More> 

Government Shutdown Could Disrupt Health Care Access – October 1, 2025 – The government shutdown highlights partisan divisions over health care funding, with Democrats pushing for ACA subsidy extensions and Republicans seeking a separate policy debate. Telehealth and home care services face potential disruptions, impacting rural and mobility-limited patients, with possible shifts back to in-person visits. <Read More> 

Trump Announces ‘TrumpRx’ Site for Discounted Drugs and Deal with Pfizer to Lower Prices – September 30, 2025 – President Donald Trump on Tuesday announced a multipronged effort aimed at lowering drug costs in the United States, including the creation of a “TrumpRx” direct-to-consumer website where Americans can buy medicine at discounted prices and a sweeping deal with Pfizer to reduce the prices of many of its products. “The United States is done subsidizing the health care of the rest of the world,” Trump said at a news conference. “By taking this bold step, we’re ending the era of global price gouging at the expense of American families.” <Read More> 

AstraZeneca to Enter Direct-to-Consumer Discount Prescription Market – September 29, 2025 – Digital prescription medication customers have a new option for low-cost medications that cuts out the middleman. Global pharmaceutical company AstraZeneca will launch AstraZeneca Direct, an online direct-to-consumer platform designed to create a way for eligible patients to gain access to their prescribed medications at a transparent cash price with home delivery, on Wednesday, Oct. 1, 2025. <Read More> 

FDA Alleges Association Between Prenatal Acetaminophen Use and Autism in Children – September 23, 2025 – The FDA has announced that it is initiating the process for a label change—and alerting physicians across the country—reflecting supposed evidence suggesting that the use of acetaminophen (Tylenol®; Kenvue) by pregnant women may be associated with a heightened risk of neurological conditions, including attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD), or autism. However, the agency also notes that while numerous studies describe an association between acetaminophen and neurological conditions, a causal relationship has not been established. <Read More> 

Ob/Gyn Group Advises Against Cannabis Use During Pregnancy, Recommends Universal Screening – September 18, 2025 – New guidance from the American College of Obstetricians and Gynecologists advises that people abstain from cannabis use during pregnancy and lactation and recommends that providers ask all of their patients about cannabis use before, during and after pregnancy to help avoid potential risks. <Read More> 

340B in the News

Hospitals' Administrative Burden Under 340B Pilot far Outstrips Government's Estimates, AHA Says – October 2, 2025 – The federal agency overseeing the controversial 340B Rebate Model Pilot Program has “vastly underestimated” how much time and money hospitals obligated to participate will spend on reporting burdens, the American Hospital Association (AHA) wrote in a Tuesday letter. The one-year test run—largely supported by drugmakers and denounced by hospitals—is set to kick off Jan. 1, with the Health Resources and Services Administration (HRSA) set to announce manufacturers’ approved application and rebate plans by Oct. 15. <Read More> 

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Clinical Insights: October 22nd, 2025

New Drug/Vaccine Approval

Jascayd® (nerandomilast) Tablets – New Drug Approval – October 7, 2025 -The U.S. Food and Drug Administration (FDA) approved Jascayd® (nerandomilast) tablets to treat idiopathic pulmonary fibrosis (IPF), a rare, serious, and progressive disease with no cure and limited treatments. This is the first new therapy approved in more than 10 years for IPF. <Read More>

Lasix® ONYU (furosemide) Injection – New Drug Approval – October 7, 2025 - Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) announced that its partner SQ Innovation Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Lasix® ONYU (furosemide injection), a novel drug-device combination for the treatment of edema (due to fluid overload) in adult patients with chronic heart failure. Lasix® ONYU can be administered subcutaneously outside the healthcare setting for selected patients, as prescribed by a clinician, without the need for a healthcare professional to administer the drug. <Read More> 

Rhapsido® (remibrutinib) Tablets – New Drug Approval – September 30, 2025 - Novartis announced that Rhapsido® (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Rhapsido® is a pill taken twice daily and does not require injections or lab monitoring. It is the first FDA-approved Bruton’s tyrosine kinase inhibitor (BTKi) for CSU. Rhapsido® helps to inhibit the release of histamine and other proinflammatory mediators by targeting BTK, offering a unique approach to CSU treatment. <Read More> 

Qivigy® (immune globulin intravenous, human-kthm) Solution for Infusion – New Drug Approval – September 26, 2025 - Kedrion Biopharma announced that it has received FDA approval for Qivigy® immune globulin intravenous (human)-kthm 10% liquid, indicated for treatment of adults with primary humoral immunodeficiency (PI)—a serious and often underdiagnosed group of disorders that compromise the immune system’s ability to function effectively. Qivigy® a 10% IVIG therapy, developed in Kedrion’s research labs and produced exclusively by Kedrion through its globally integrated network of facilities in the United States and Italy, addresses the unmet needs of patients with PI. <Read More> 

Clotic® (clotrimazole) Otic Solution – New Drug Approval – September 26, 2025 - Salvat Pharmaceutical Group has announced that the U.S. Food and Drug Administration (FDA) has approved 1% otic clotrimazole, the first targeted treatment for otomycosis, for commercialization in the United States. <Read More> 

Inluriyo™ (imlunestrant) Tablets – New Drug Approval – September 25, 2025 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Inluriyo™ (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET). <Read More> 

Palsonify™ (paltusotine) Tablets – New Drug Approval – September 25, 2025 - Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) announced that the U.S. Food and Drug Administration (FDA) approved Palsonify™ (paltusotine) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Palsonify™, a selectively-targeted somatostatin receptor type 2 nonpeptide (SST2) agonist, is now the first once-daily, oral treatment approved for adults with acromegaly. <Read More> 

Bondlido™ (lidocaine) Topical System – New Drug Approval – September 25, 2025 - MEDRx announced that the U.S. Food and Drug Administration (FDA) has approved “Bondlido™”, a lidocaine patch MEDRx Group and D. Western Therapeutics Institute, Inc. has jointly developed, in adults for relief of pain associated with post-herpetic neuralgia (PHN). Going forward, preparations for the launch will be made, including the selection of sales partners, with sales planned to begin in the US in the first half of 2026. <Read More> 

Forzinity™ (elamipretide hydrochloride) Injection – New Drug Approval – September 19, 2025 - Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a commercial-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Forzinity™ (elamipretide) injection to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kilograms (kg) (approximately 66 pounds). Barth syndrome is a life-limiting pediatric mitochondrial cardioskeletal disease that affects approximately 150 individuals in the United States. <Read More> 

Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) Injection – New Drug Approval – September 19, 2025 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for Keytruda® (pembrolizumab). Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc. Keytruda Qlex™ must be administered by a health care provider (HCP). Merck expects to have Keytruda Qlex™ (pronounced key-TRUE-duh Q-lex) available in the U.S. in late September. <Read More> 

Subvenite® (lamotrigine) Oral Suspension – New Drug Approval – September 16, 2025 - OWP Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Subvenite® Oral Suspension, the first and only lamotrigine oral suspension in the United States. This innovative formulation will offer treatment options for patients and healthcare providers by offering a flexible, patient-friendly alternative to tablets. <Read More> 

Enbumyst™ (bumetanide) Nasal Spray – New Drug Approval – September 15, 2025 - Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiovascular and renal disease, announced that the U.S. Food and Drug Administration (FDA) has approved Enbumyst™ (bumetanide nasal spray). Enbumyst™ is indicated for the treatment of edema associated with congestive heart failure (CHF), and hepatic and renal disease, including nephrotic syndrome in adults. <Read More> 

Inlexzo™ (gemcitabine) intravesical system - formerly TAR-200 – New Drug Approval – September 9, 2025 - Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved Inlexzo™ (gemcitabine intravesical system), a new, potentially practice-changing approach for treating patients with certain types of bladder cancer, addressing the need for additional options following unsuccessful BCG therapy and for patients refusing or ineligible for bladder removal surgery (radical cystectomy). Inlexzo™, previously referred to as TAR-200, is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. <Read More> 

New Label Expansions

Tezspire® (tezepelumab-ekko) Injection – New Label Expansion – October 17, 2025 - Amgen (NASDAQ:AMGN) and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) approved Tezspire® (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older. Tezspire® is the first and only biologic approved for CRSwNP that targets thymic stromal lymphopoietin (TSLP). <Read More> 

Rinvoq® (upadacitinib) Extended-Release Tablets – New Label Expansion – October 10, 2025 - AbbVie (NYSE: ABBV) announced the U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) that updates the indication statement for Rinvoq® (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD). <Read More> 

Uzedy® (risperidone) Extended-Release Injectable Suspension – New Label Expansion – October 10, 2025 - Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), announced that the U.S. Food and Drug Administration (FDA) has approved Uzedy® (risperidone) as a once-monthly extended-release injectable suspension as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder (BD-I) in adults. <Read More> 

Libtayo® (cemiplimab-rwlc) Injection – New Label Expansion – October 8, 2025 - Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. The FDA evaluated Libtayo® under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the treatment of serious conditions. An additional regulatory application is also under review in the European Union, with a decision expected by the first half of 2026. <Read More> 

Simponi® (golimumab) Injection – New Label Expansion – October 7, 2025 - Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Simponi® (golimumab) for the treatment of children living with moderately to severely active ulcerative colitis (UC), weighing at least 15 kg. This approval builds on the Simponi® indication for adults living with moderately to severely active UC, which together represents more than one million Americans living with this condition. <Read More> 

Zoryve® (roflumilast) Cream and Foam – New Label Expansion – October 4, 2025 - Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company dedicated to developing meaningful innovations in immuno-dermatology, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Zoryve® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age. <Read More> 

Zepzelca® (lurbinectedin) Injection – New Label Expansion – October 2, 2025 - Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) has granted approval for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza®) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The approval marks the first combination therapy for first-line maintenance treatment of ES-SCLC, a fast-growing and aggressive cancer with limited treatment options. <Read More> 

Tremfya® (guselkumab) Injection – New Label Expansion – September 26, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya® (guselkumab) for the treatment of children six years and older who also weigh at least 40 kg with moderate to severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA). <Read More>  

Evkeeza® (evinacumab-dgnb) Injection – New Label Expansion – September 26, 2025 - Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved Evkeeza® (evinacumab-dgnb) ANGPTL3 antibody as an adjunct to diet and exercise and other lipid-lowering therapies for the treatment of children from age 1 to less than 5 years old with homozygous familial hypercholesterolemia (HoFH). Evkeeza® was initially approved in 2021 for adults and adolescents aged 12 years and older with HoFH based on a placebo-controlled trial showing Evkeeza®, when added to standard lipid-lowering therapies, could lower LDL-C by about 50% compared to placebo in this high unmet need population. <Read More> 

Tremfya® (guselkumab) Injection – New Label Expansion – September 19, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). With this approval, Tremfya® is the first and only IL-23 inhibitor to offer both SC and intravenous (IV) induction options for the treatment of UC and Crohn’s disease (CD), which combined affect approximately three million Americans. <Read More> 

Opzelura® (ruxolitinib) Cream – New Label Expansion – September 18, 2025 - Incyte (Nasdaq: INCY) announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura® (ruxolitinib) cream 1.5%, a topical Janus kinase (JAK) inhibitor, for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised children two years of age and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not recommended. <Read More> 

Vyjuvek® (beremagene geperpavec-svdt) Topical Gel – New Label Expansion – September 12, 2025 - Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced that the United States Food and Drug Administration (FDA) approved a label update for Vyjuvek® (beremagene geperpavec-svdt) that expands the Vyjuvek® eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibility with respect to Vyjuvek® application and managing wound dressings. <Read More> 

Koselugo® (selumetinib) Capsules and Oral Granules – New Label Expansion – September 10, 2025 - The Food and Drug Administration approved selumetinib (Koselugo®, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN. <Read More> 

Vonvendi® (von willebrand factor (recombinant)) for Injection– New Label Expansion – September 5, 2025 - Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Vonvendi® [von Willebrand factor (Recombinant)], expanding the indication to include routine prophylaxis to reduce the frequency of bleeding episodes in adults with von Willebrand Disease (VWD), including those with Type 1 and 2 disease, and on-demand and perioperative management of bleeding in pediatric patients with VWD. Vonvendi® was previously approved for on-demand and perioperative use in adults with VWD and routine prophylactic use in adults with severe Type 3 VWD receiving on-demand therapy. <Read More> 

New Drug Shortage

October 20, 2025

October 17, 2025

October 16, 2025

October 10, 2025

October 09, 2025

Updated Drug Shortage

October 17, 2025

October 16, 2025

October 15, 2025

October 10, 2025

October 09, 2025

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Eydenzelt® (aflibercept-boav) Injection- New Eyleaâ Biosimilar Approval – October 9, 2025 - Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Eydenzelt® (aflibercept-boav), biosimilar referencing Eylea® (aflibercept), for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR). <Read More> 

Enoby™ (denosumab-qbde) Injection - New Proliaâ Biosimilar Approval – September 26, 2025 - Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announce that the U.S. Food and Drug Administration (FDA) has granted approval for the Biologics License Applications (BLA) of their biosimilar denosumab products, EnobyTM (denosumab-qbde) and XtrenboTM (denosumab-qbde), referencing Prolia® and Xgeva® respectively. <Read More> 

Xtrenbo™ (denosumab-qbde) Injection - New Xvega® Biosimilar Approval – September 26, 2025 - Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announce that the U.S. Food and Drug Administration (FDA) has granted approval for the Biologics License Applications (BLA) of their biosimilar denosumab products, Enoby™ (denosumab-qbde) and Xtrenbo™ (denosumab-qbde), referencing Prolia® and Xgeva® respectively. <Read More> 

Aukelso (denosumab-kyqq) Injection - New Xvega® Biosimilar Approval – September 16, 2025 - – Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Bosaya™ (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single dose prefilled syringe (PFS), and Aukelso™ (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial, biosimilars of Prolia® and Xgeva® respectively. In addition, the U.S. FDA granted provisional interchangeability designation for both Bosaya™ and Aukelso™. <Read More> 

Bosaya™ (denosumab-kyqq) Injection – New Proliaâ Biosimilar Approval – September 16, 2025 - Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Bosaya™ (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single dose prefilled syringe (PFS), and Aukelso™ (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial, biosimilars of Prolia® and Xgeva® respectively. In addition, the U.S. FDA granted provisional interchangeability designation for both Bosaya™ and Aukelso™. <Read More> 

Clinical and Pharmacy News

Pharmacy Profession Unites to Publish Guiding Principles for State Policy on Pharmacy Personnel-Administered Vaccines – October 16, 2025 –The Pharmacy-based Vaccine Access Work Group, consisting of representatives from a diverse group of 12 organizations across pharmacy practice settings, jointly published guiding principles for state policy on pharmacy personnel–administered vaccines. This marks an unprecedented level of collaboration between pharmacy professionals, symbolizing a strong commitment from the field of pharmacy to national public health interests. <Read More> 

WHO Warns of Widespread Resistance to Common Antibiotics Worldwide – October 13, 2025 – One in six laboratory-confirmed bacterial infections causing common infections in people worldwide in 2023 were resistant to antibiotic treatments, according to a new World Health Organization (WHO) report launched today. Between 2018 and 2023, antibiotic resistance rose in over 40% of the pathogen-antibiotic combinations monitored, with an average annual increase of 5–15%. Data reported to the WHO Global Antimicrobial Resistance and Use Surveillance System (GLASS) from over 100 countries cautions that increasing resistance to essential antibiotics poses a growing threat to global health. <Read More> 

Why Pharmacist Burnout is a Patient Safety Issue – October 5, 2025 – Behind every prescription safely dispensed stands a pharmacist making dozens of clinical decisions under mounting pressure. What happens when that pressure becomes unbearable? When the professionals who are the last line of defense against medication harm are pushed to their breaking point, patient safety breaks with them. This crisis is real and it is often invisible. Surveys and workplace reports repeatedly show that large numbers of pharmacists experience burnout and consider leaving the profession. Unlike physician burnout, which has received public attention and resources, pharmacist burnout remains under-recognized by many health care leaders and policymakers. <Read More> 

Pharmacist-Led Community Health Interventions Provide Practical, Effective Treatment for Older Adults – October 3, 2025 – Through community health interventions geared toward older adult populations, clinical pharmacists proved their ability to provide practical and effective guidance on managing patients’ medications and chronic diseases, according to findings from a study published in Pharmacy. Despite the need for further research to understand its long-term impacts, preliminary results from the researchers’ Pharm2Home initiative were significantly promising and could serve as a precursor for the development of more pharmacist-led clinical services. <Read More> 

Government Shutdown Could Disrupt Health Care Access – October 1, 2025 – The government shutdown highlights partisan divisions over health care funding, with Democrats pushing for ACA subsidy extensions and Republicans seeking a separate policy debate. Telehealth and home care services face potential disruptions, impacting rural and mobility-limited patients, with possible shifts back to in-person visits. <Read More> 

Trump Announces ‘TrumpRx’ Site for Discounted Drugs and Deal with Pfizer to Lower Prices – September 30, 2025 – President Donald Trump on Tuesday announced a multipronged effort aimed at lowering drug costs in the United States, including the creation of a “TrumpRx” direct-to-consumer website where Americans can buy medicine at discounted prices and a sweeping deal with Pfizer to reduce the prices of many of its products. “The United States is done subsidizing the health care of the rest of the world,” Trump said at a news conference. “By taking this bold step, we’re ending the era of global price gouging at the expense of American families.” <Read More> 

AstraZeneca to Enter Direct-to-Consumer Discount Prescription Market – September 29, 2025 – Digital prescription medication customers have a new option for low-cost medications that cuts out the middleman. Global pharmaceutical company AstraZeneca will launch AstraZeneca Direct, an online direct-to-consumer platform designed to create a way for eligible patients to gain access to their prescribed medications at a transparent cash price with home delivery, on Wednesday, Oct. 1, 2025. <Read More> 

FDA Alleges Association Between Prenatal Acetaminophen Use and Autism in Children – September 23, 2025 – The FDA has announced that it is initiating the process for a label change—and alerting physicians across the country—reflecting supposed evidence suggesting that the use of acetaminophen (Tylenol®; Kenvue) by pregnant women may be associated with a heightened risk of neurological conditions, including attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD), or autism. However, the agency also notes that while numerous studies describe an association between acetaminophen and neurological conditions, a causal relationship has not been established. <Read More> 

Ob/Gyn Group Advises Against Cannabis Use During Pregnancy, Recommends Universal Screening – September 18, 2025 – New guidance from the American College of Obstetricians and Gynecologists advises that people abstain from cannabis use during pregnancy and lactation and recommends that providers ask all of their patients about cannabis use before, during and after pregnancy to help avoid potential risks. <Read More> 

340B in the News

Hospitals' Administrative Burden Under 340B Pilot far Outstrips Government's Estimates, AHA Says – October 2, 2025 – The federal agency overseeing the controversial 340B Rebate Model Pilot Program has “vastly underestimated” how much time and money hospitals obligated to participate will spend on reporting burdens, the American Hospital Association (AHA) wrote in a Tuesday letter. The one-year test run—largely supported by drugmakers and denounced by hospitals—is set to kick off Jan. 1, with the Health Resources and Services Administration (HRSA) set to announce manufacturers’ approved application and rebate plans by Oct. 15. <Read More> 

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Clinical Insights: October 22nd, 2025

New Drug/Vaccine Approval

Jascayd® (nerandomilast) Tablets – New Drug Approval – October 7, 2025 -The U.S. Food and Drug Administration (FDA) approved Jascayd® (nerandomilast) tablets to treat idiopathic pulmonary fibrosis (IPF), a rare, serious, and progressive disease with no cure and limited treatments. This is the first new therapy approved in more than 10 years for IPF. <Read More>

Lasix® ONYU (furosemide) Injection – New Drug Approval – October 7, 2025 - Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) announced that its partner SQ Innovation Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Lasix® ONYU (furosemide injection), a novel drug-device combination for the treatment of edema (due to fluid overload) in adult patients with chronic heart failure. Lasix® ONYU can be administered subcutaneously outside the healthcare setting for selected patients, as prescribed by a clinician, without the need for a healthcare professional to administer the drug. <Read More> 

Rhapsido® (remibrutinib) Tablets – New Drug Approval – September 30, 2025 - Novartis announced that Rhapsido® (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Rhapsido® is a pill taken twice daily and does not require injections or lab monitoring. It is the first FDA-approved Bruton’s tyrosine kinase inhibitor (BTKi) for CSU. Rhapsido® helps to inhibit the release of histamine and other proinflammatory mediators by targeting BTK, offering a unique approach to CSU treatment. <Read More> 

Qivigy® (immune globulin intravenous, human-kthm) Solution for Infusion – New Drug Approval – September 26, 2025 - Kedrion Biopharma announced that it has received FDA approval for Qivigy® immune globulin intravenous (human)-kthm 10% liquid, indicated for treatment of adults with primary humoral immunodeficiency (PI)—a serious and often underdiagnosed group of disorders that compromise the immune system’s ability to function effectively. Qivigy® a 10% IVIG therapy, developed in Kedrion’s research labs and produced exclusively by Kedrion through its globally integrated network of facilities in the United States and Italy, addresses the unmet needs of patients with PI. <Read More> 

Clotic® (clotrimazole) Otic Solution – New Drug Approval – September 26, 2025 - Salvat Pharmaceutical Group has announced that the U.S. Food and Drug Administration (FDA) has approved 1% otic clotrimazole, the first targeted treatment for otomycosis, for commercialization in the United States. <Read More> 

Inluriyo™ (imlunestrant) Tablets – New Drug Approval – September 25, 2025 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Inluriyo™ (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET). <Read More> 

Palsonify™ (paltusotine) Tablets – New Drug Approval – September 25, 2025 - Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) announced that the U.S. Food and Drug Administration (FDA) approved Palsonify™ (paltusotine) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Palsonify™, a selectively-targeted somatostatin receptor type 2 nonpeptide (SST2) agonist, is now the first once-daily, oral treatment approved for adults with acromegaly. <Read More> 

Bondlido™ (lidocaine) Topical System – New Drug Approval – September 25, 2025 - MEDRx announced that the U.S. Food and Drug Administration (FDA) has approved “Bondlido™”, a lidocaine patch MEDRx Group and D. Western Therapeutics Institute, Inc. has jointly developed, in adults for relief of pain associated with post-herpetic neuralgia (PHN). Going forward, preparations for the launch will be made, including the selection of sales partners, with sales planned to begin in the US in the first half of 2026. <Read More> 

Forzinity™ (elamipretide hydrochloride) Injection – New Drug Approval – September 19, 2025 - Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a commercial-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Forzinity™ (elamipretide) injection to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kilograms (kg) (approximately 66 pounds). Barth syndrome is a life-limiting pediatric mitochondrial cardioskeletal disease that affects approximately 150 individuals in the United States. <Read More> 

Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) Injection – New Drug Approval – September 19, 2025 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for Keytruda® (pembrolizumab). Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc. Keytruda Qlex™ must be administered by a health care provider (HCP). Merck expects to have Keytruda Qlex™ (pronounced key-TRUE-duh Q-lex) available in the U.S. in late September. <Read More> 

Subvenite® (lamotrigine) Oral Suspension – New Drug Approval – September 16, 2025 - OWP Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Subvenite® Oral Suspension, the first and only lamotrigine oral suspension in the United States. This innovative formulation will offer treatment options for patients and healthcare providers by offering a flexible, patient-friendly alternative to tablets. <Read More> 

Enbumyst™ (bumetanide) Nasal Spray – New Drug Approval – September 15, 2025 - Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiovascular and renal disease, announced that the U.S. Food and Drug Administration (FDA) has approved Enbumyst™ (bumetanide nasal spray). Enbumyst™ is indicated for the treatment of edema associated with congestive heart failure (CHF), and hepatic and renal disease, including nephrotic syndrome in adults. <Read More> 

Inlexzo™ (gemcitabine) intravesical system - formerly TAR-200 – New Drug Approval – September 9, 2025 - Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved Inlexzo™ (gemcitabine intravesical system), a new, potentially practice-changing approach for treating patients with certain types of bladder cancer, addressing the need for additional options following unsuccessful BCG therapy and for patients refusing or ineligible for bladder removal surgery (radical cystectomy). Inlexzo™, previously referred to as TAR-200, is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. <Read More> 

New Label Expansions

Tezspire® (tezepelumab-ekko) Injection – New Label Expansion – October 17, 2025 - Amgen (NASDAQ:AMGN) and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) approved Tezspire® (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older. Tezspire® is the first and only biologic approved for CRSwNP that targets thymic stromal lymphopoietin (TSLP). <Read More> 

Rinvoq® (upadacitinib) Extended-Release Tablets – New Label Expansion – October 10, 2025 - AbbVie (NYSE: ABBV) announced the U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) that updates the indication statement for Rinvoq® (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD). <Read More> 

Uzedy® (risperidone) Extended-Release Injectable Suspension – New Label Expansion – October 10, 2025 - Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), announced that the U.S. Food and Drug Administration (FDA) has approved Uzedy® (risperidone) as a once-monthly extended-release injectable suspension as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder (BD-I) in adults. <Read More> 

Libtayo® (cemiplimab-rwlc) Injection – New Label Expansion – October 8, 2025 - Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. The FDA evaluated Libtayo® under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the treatment of serious conditions. An additional regulatory application is also under review in the European Union, with a decision expected by the first half of 2026. <Read More> 

Simponi® (golimumab) Injection – New Label Expansion – October 7, 2025 - Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Simponi® (golimumab) for the treatment of children living with moderately to severely active ulcerative colitis (UC), weighing at least 15 kg. This approval builds on the Simponi® indication for adults living with moderately to severely active UC, which together represents more than one million Americans living with this condition. <Read More> 

Zoryve® (roflumilast) Cream and Foam – New Label Expansion – October 4, 2025 - Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company dedicated to developing meaningful innovations in immuno-dermatology, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Zoryve® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age. <Read More> 

Zepzelca® (lurbinectedin) Injection – New Label Expansion – October 2, 2025 - Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) has granted approval for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza®) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The approval marks the first combination therapy for first-line maintenance treatment of ES-SCLC, a fast-growing and aggressive cancer with limited treatment options. <Read More> 

Tremfya® (guselkumab) Injection – New Label Expansion – September 26, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya® (guselkumab) for the treatment of children six years and older who also weigh at least 40 kg with moderate to severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA). <Read More>  

Evkeeza® (evinacumab-dgnb) Injection – New Label Expansion – September 26, 2025 - Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved Evkeeza® (evinacumab-dgnb) ANGPTL3 antibody as an adjunct to diet and exercise and other lipid-lowering therapies for the treatment of children from age 1 to less than 5 years old with homozygous familial hypercholesterolemia (HoFH). Evkeeza® was initially approved in 2021 for adults and adolescents aged 12 years and older with HoFH based on a placebo-controlled trial showing Evkeeza®, when added to standard lipid-lowering therapies, could lower LDL-C by about 50% compared to placebo in this high unmet need population. <Read More> 

Tremfya® (guselkumab) Injection – New Label Expansion – September 19, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). With this approval, Tremfya® is the first and only IL-23 inhibitor to offer both SC and intravenous (IV) induction options for the treatment of UC and Crohn’s disease (CD), which combined affect approximately three million Americans. <Read More> 

Opzelura® (ruxolitinib) Cream – New Label Expansion – September 18, 2025 - Incyte (Nasdaq: INCY) announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura® (ruxolitinib) cream 1.5%, a topical Janus kinase (JAK) inhibitor, for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised children two years of age and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not recommended. <Read More> 

Vyjuvek® (beremagene geperpavec-svdt) Topical Gel – New Label Expansion – September 12, 2025 - Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced that the United States Food and Drug Administration (FDA) approved a label update for Vyjuvek® (beremagene geperpavec-svdt) that expands the Vyjuvek® eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibility with respect to Vyjuvek® application and managing wound dressings. <Read More> 

Koselugo® (selumetinib) Capsules and Oral Granules – New Label Expansion – September 10, 2025 - The Food and Drug Administration approved selumetinib (Koselugo®, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN. <Read More> 

Vonvendi® (von willebrand factor (recombinant)) for Injection– New Label Expansion – September 5, 2025 - Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Vonvendi® [von Willebrand factor (Recombinant)], expanding the indication to include routine prophylaxis to reduce the frequency of bleeding episodes in adults with von Willebrand Disease (VWD), including those with Type 1 and 2 disease, and on-demand and perioperative management of bleeding in pediatric patients with VWD. Vonvendi® was previously approved for on-demand and perioperative use in adults with VWD and routine prophylactic use in adults with severe Type 3 VWD receiving on-demand therapy. <Read More> 

New Drug Shortage

October 20, 2025

October 17, 2025

October 16, 2025

October 10, 2025

October 09, 2025

Updated Drug Shortage

October 17, 2025

October 16, 2025

October 15, 2025

October 10, 2025

October 09, 2025

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Eydenzelt® (aflibercept-boav) Injection- New Eyleaâ Biosimilar Approval – October 9, 2025 - Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Eydenzelt® (aflibercept-boav), biosimilar referencing Eylea® (aflibercept), for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR). <Read More> 

Enoby™ (denosumab-qbde) Injection - New Proliaâ Biosimilar Approval – September 26, 2025 - Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announce that the U.S. Food and Drug Administration (FDA) has granted approval for the Biologics License Applications (BLA) of their biosimilar denosumab products, EnobyTM (denosumab-qbde) and XtrenboTM (denosumab-qbde), referencing Prolia® and Xgeva® respectively. <Read More> 

Xtrenbo™ (denosumab-qbde) Injection - New Xvega® Biosimilar Approval – September 26, 2025 - Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announce that the U.S. Food and Drug Administration (FDA) has granted approval for the Biologics License Applications (BLA) of their biosimilar denosumab products, Enoby™ (denosumab-qbde) and Xtrenbo™ (denosumab-qbde), referencing Prolia® and Xgeva® respectively. <Read More> 

Aukelso (denosumab-kyqq) Injection - New Xvega® Biosimilar Approval – September 16, 2025 - – Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Bosaya™ (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single dose prefilled syringe (PFS), and Aukelso™ (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial, biosimilars of Prolia® and Xgeva® respectively. In addition, the U.S. FDA granted provisional interchangeability designation for both Bosaya™ and Aukelso™. <Read More> 

Bosaya™ (denosumab-kyqq) Injection – New Proliaâ Biosimilar Approval – September 16, 2025 - Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Bosaya™ (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single dose prefilled syringe (PFS), and Aukelso™ (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial, biosimilars of Prolia® and Xgeva® respectively. In addition, the U.S. FDA granted provisional interchangeability designation for both Bosaya™ and Aukelso™. <Read More> 

Clinical and Pharmacy News

Pharmacy Profession Unites to Publish Guiding Principles for State Policy on Pharmacy Personnel-Administered Vaccines – October 16, 2025 –The Pharmacy-based Vaccine Access Work Group, consisting of representatives from a diverse group of 12 organizations across pharmacy practice settings, jointly published guiding principles for state policy on pharmacy personnel–administered vaccines. This marks an unprecedented level of collaboration between pharmacy professionals, symbolizing a strong commitment from the field of pharmacy to national public health interests. <Read More> 

WHO Warns of Widespread Resistance to Common Antibiotics Worldwide – October 13, 2025 – One in six laboratory-confirmed bacterial infections causing common infections in people worldwide in 2023 were resistant to antibiotic treatments, according to a new World Health Organization (WHO) report launched today. Between 2018 and 2023, antibiotic resistance rose in over 40% of the pathogen-antibiotic combinations monitored, with an average annual increase of 5–15%. Data reported to the WHO Global Antimicrobial Resistance and Use Surveillance System (GLASS) from over 100 countries cautions that increasing resistance to essential antibiotics poses a growing threat to global health. <Read More> 

Why Pharmacist Burnout is a Patient Safety Issue – October 5, 2025 – Behind every prescription safely dispensed stands a pharmacist making dozens of clinical decisions under mounting pressure. What happens when that pressure becomes unbearable? When the professionals who are the last line of defense against medication harm are pushed to their breaking point, patient safety breaks with them. This crisis is real and it is often invisible. Surveys and workplace reports repeatedly show that large numbers of pharmacists experience burnout and consider leaving the profession. Unlike physician burnout, which has received public attention and resources, pharmacist burnout remains under-recognized by many health care leaders and policymakers. <Read More> 

Pharmacist-Led Community Health Interventions Provide Practical, Effective Treatment for Older Adults – October 3, 2025 – Through community health interventions geared toward older adult populations, clinical pharmacists proved their ability to provide practical and effective guidance on managing patients’ medications and chronic diseases, according to findings from a study published in Pharmacy. Despite the need for further research to understand its long-term impacts, preliminary results from the researchers’ Pharm2Home initiative were significantly promising and could serve as a precursor for the development of more pharmacist-led clinical services. <Read More> 

Government Shutdown Could Disrupt Health Care Access – October 1, 2025 – The government shutdown highlights partisan divisions over health care funding, with Democrats pushing for ACA subsidy extensions and Republicans seeking a separate policy debate. Telehealth and home care services face potential disruptions, impacting rural and mobility-limited patients, with possible shifts back to in-person visits. <Read More> 

Trump Announces ‘TrumpRx’ Site for Discounted Drugs and Deal with Pfizer to Lower Prices – September 30, 2025 – President Donald Trump on Tuesday announced a multipronged effort aimed at lowering drug costs in the United States, including the creation of a “TrumpRx” direct-to-consumer website where Americans can buy medicine at discounted prices and a sweeping deal with Pfizer to reduce the prices of many of its products. “The United States is done subsidizing the health care of the rest of the world,” Trump said at a news conference. “By taking this bold step, we’re ending the era of global price gouging at the expense of American families.” <Read More> 

AstraZeneca to Enter Direct-to-Consumer Discount Prescription Market – September 29, 2025 – Digital prescription medication customers have a new option for low-cost medications that cuts out the middleman. Global pharmaceutical company AstraZeneca will launch AstraZeneca Direct, an online direct-to-consumer platform designed to create a way for eligible patients to gain access to their prescribed medications at a transparent cash price with home delivery, on Wednesday, Oct. 1, 2025. <Read More> 

FDA Alleges Association Between Prenatal Acetaminophen Use and Autism in Children – September 23, 2025 – The FDA has announced that it is initiating the process for a label change—and alerting physicians across the country—reflecting supposed evidence suggesting that the use of acetaminophen (Tylenol®; Kenvue) by pregnant women may be associated with a heightened risk of neurological conditions, including attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD), or autism. However, the agency also notes that while numerous studies describe an association between acetaminophen and neurological conditions, a causal relationship has not been established. <Read More> 

Ob/Gyn Group Advises Against Cannabis Use During Pregnancy, Recommends Universal Screening – September 18, 2025 – New guidance from the American College of Obstetricians and Gynecologists advises that people abstain from cannabis use during pregnancy and lactation and recommends that providers ask all of their patients about cannabis use before, during and after pregnancy to help avoid potential risks. <Read More> 

340B in the News

Hospitals' Administrative Burden Under 340B Pilot far Outstrips Government's Estimates, AHA Says – October 2, 2025 – The federal agency overseeing the controversial 340B Rebate Model Pilot Program has “vastly underestimated” how much time and money hospitals obligated to participate will spend on reporting burdens, the American Hospital Association (AHA) wrote in a Tuesday letter. The one-year test run—largely supported by drugmakers and denounced by hospitals—is set to kick off Jan. 1, with the Health Resources and Services Administration (HRSA) set to announce manufacturers’ approved application and rebate plans by Oct. 15. <Read More> 

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Clinical Insights: September 10th, 2025

New Drug/Vaccine Approval

Wayrilz™ (rilzabrutinib) Tablets – New Drug Approval – August 28, 2025 – The US Food and Drug Administration (FDA) has approved Wayrilz™ (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The approval was based on the pivotal LUNA 3 phase 3 study, in which Wayrilz™ met the primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms. <Read More>

Dawnzera™ (donidalorsen) Injection – New Drug Approval – August 21, 2025 – Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has approved Dawnzera™ (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. Dawnzera™ is the first and only RNA-targeted medicine approved for HAE, designed to target plasma prekallikrein (PKK), a key protein that activates inflammatory mediators associated with acute attacks of HAE. Dawnzera™ 80mg is self-administered via subcutaneous autoinjector once every four (Q4W) or eight weeks (Q8W). <Read More> 

Tonmya™ (cyclobenzaprine hydrochloride) - formerly TNX-102 SL – New Drug Approval – August 15, 2025 – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company, announced that the U.S. Food and Drug Administration (FDA) approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Tonmya™ is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual (under the tongue) formulation that is designed for rapid absorption into the bloodstream. Tonmya™ is the first new FDA-approved therapy for the treatment of fibromyalgia in over 15 years. <Read More>

Papzimeos™ (zopapogene imadenovec-drba) Injection – New Drug Approval – August 14, 2025 – Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, announced that the US Food and Drug Administration (FDA) has approved Papzimeos™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). Papzimeos™ is the first and only FDA-approved therapy for the treatment of adults with RRP. Precigen completed submission of the rolling Biologics License Application (BLA) in December 2024 under an accelerated approval pathway; however, the FDA has granted Papzimeos™ full approval, which does not require a confirmatory clinical trial. Papzimeos™ is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins—the root cause of RRP. Papzimeos™ is delivered via four subcutaneous injections over a 12-week interval. <Read More>

Brinsupri™ (brensocatib) Tablets – New Drug Approval – August 12, 2025 – Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, announced that the U.S. Food and Drug Administration (FDA) has approved first-in-class Brinsupri™ (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. Brinsupri™ is the first and only FDA-approved treatment for NCFB, giving hundreds of thousands of patients and clinicians across the U.S. an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline. <Read More> 

Hernexeos® (zongertinib) Tablets – New Drug Approval – August 8, 2025 – Boehringer Ingelheim’s Hernexeos® (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA). The kinase inhibitor is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. <Read More>  

KETARx™ (ketamine hydrochloride) Injection – New Drug Approval – August 7, 2025 – PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, announced the advancement of its ketamine transdermal patch as a next-generation, non-opioid pain relief solution, building on the recent FDA approval of its IV ketamine product (KETARx™). <Read More> 

Modeyso™ (dordaviprone) Capsules – New Drug Approval – August 6, 2025 – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the Phase 3 ACTION confirmatory trial. <Read More>

New Label Expansions

Leqembi® (lecanemab-irmb) Injection – New Label Expansion – August 29, 2025 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab-irmb subcutaneous injection (U.S. brand name: Leqembi® Iqlik™, pronounced "I Click") for maintenance dosing. Leqembi® Iqlik™ is a subcutaneous autoinjector (SC-AI) developed by Eisai, containing 360 mg/1.8 mL (200 mg/mL) that can be administered in approximately 15 seconds. <Read More> 

Comirnaty® (COVID-19 Vaccine, mRNA) Injection – New Label Expansion – August 27, 2025 – Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (Comirnaty® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. <Read More>

Filspari® (sparsentan) Tablets – New Label Expansion – August 27, 2025 – Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that the U.S. Food and Drug Administration (FDA) has approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for Filspari® (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist for the treatment of IgA nephropathy (IgAN). <Read More> 

mNEXSPIKE® (COVID-19 Vaccine, mRNA) Injection – New Label Expansion – August 27, 2025 – Moderna, Inc. (NASDAQ:MRNA) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax® and mNEXSPIKE®, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. <Read More> 

Nuvaxovid™ (COVID-19 Vaccine, Adjuvanted) Injectable Suspension – New Label Expansion – August 27, 2025 – Novavax, Inc. (Nasdaq: NVAX) announced that the U.S. Food and Drug Administration has approved the Nuvaxovid™ 2025-2026 Formula for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. <Read More> 

Repatha® (evolocumab) Injection – New Label Expansion – August 21, 2025 – Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), commonly known as 'bad cholesterol.' The update removes a prior requirement for a patient to have been diagnosed with cardiovascular (CV) disease. <Read More> 

Wegovy® (semaglutide) Injection – New Label Expansion – August 15, 2025 – The U.S. Food and Drug Administration has approved Wegovy® (semaglutide) injection to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis (excessive scar tissue in the liver). MASH, also known as nonalcoholic steatohepatitis, is a serious liver disease. Wegovy®, which was first approved in 2017, is also approved for obesity or overweight and to reduce cardiovascular events, such as heart attacks, in individuals at high risk of these events. Approximately 6% of U.S. adults (14.9 million people) have MASH, and its prevalence is expanding. <Read More> 

Ajovy® (fremanezumab-vfrm) Injection – New Label Expansion – August 5, 2025 – Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced that the U.S. Food and Drug Administration (FDA) has approved Ajovy® for the preventive treatment of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. <Read More> 

New Drug Shortage

September 8, 2025

September 4, 2025

August 29, 2025

August 27, 2025

August 25, 2025

Updated Drug Shortage

September 5, 2025

September 4, 2025

September 3, 2025

September 2, 2025

August 29, 2025

New Drug Recall and Safety Alerts

Cyclobenzaprine Hydrochloride Tablets USP 10 mg by Unichem Pharmaceuticals (USA) Inc. – New Voluntary Recall – August 27, 2025 – Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam 7.5 mg tablets. <Read More> 

Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL by B. Braun Medical – New Voluntary Recall  – August 19, 2025 - B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL, and 0.9% Sodium Chloride Injection USP 1000 mL to the hospital level due to the presence of particulate matter inside the container. B. Braun has identified through complaints the potential for the product to contain particulate matter in solution. To date there have been no reports of serious injury, death or other adverse events associated with this issue. <Read More> 

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Walgreens Shakeup Sparks Patient Fear as Pharmacies Face More Closures After 295 Shutters – September 8, 2025 – A few months after a definitive agreement signing in March, Walgreens has been officially purchased by private equity firm Sycamore Partners for $10 billion, per a press release. Part of the deal means that Walgreens Boots Alliance and its subsidiaries are split into five separate and privately-owned operations… While the $10 billion was heavily supported by Walgreens shareholders, some industry experts worry that this decision will ultimately lead to more layoffs and closures for the brand, per what they told Healthcare Brew. <Read More>

A Pharmacy Benefit Manager Stopped Covering a GLP-1 for Obesity. Now There’s a Lawsuit – September 6, 2025 – A class-action lawsuit has been filed against CVS Caremark over its decision to stop covering Zepbound®, Eli Lilly’s blockbuster GLP-1 drug to treat obesity. When the major pharmacy benefit manager informed patients about the change this year, it suggested that there was “another covered medication that’s safe and effective for your condition and may cost less”: namely Wegovy®, from Novo Nordisk, with which CVS Caremark announced a partnership just before the change took effect. <Read More> 

The Five Biggest Challenges Facing Retail Pharmacy – August 28, 2025 – Retail pharmacy operators face an array of challenges beyond PBM reform, which many observers say remains the single biggest obstacle to operating successfully in today’s environment. Among the most pressing issues is how the Medicare price negotiations that were included in the Inflation Reduction Act will play out at the retail level. Many retailers are concerned that reimbursement mechanisms might not be adequate to support their cash flow needs. In addition, the reimbursement models that evolve for GLP-1 drugs and other high-cost medications could also pose challenges for retailers. <Read More>

Getting a Covid Shot This Fall Could be a lot More Complicated – August 22, 2025 – The millions of Americans who are used to getting their Covid-19 vaccines at a local pharmacy may face new hurdles this fall depending on where they live and whether federal health officials have decided they qualify. Pharmacists’ authority to vaccinate individuals varies across state lines. In some places, it’s dependent upon a federal advisory process that Health Secretary Robert F. Kennedy Jr. has upended. <Read More> 

Determining if LAAO Will Benefit Patients With Afib Using Novel AI Algorithm – August 16, 2025 – Researchers in Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery in collaboration with Cardiovascular Medicine developed a new artificial intelligence (AI) algorithm to identify patients likely to benefit from transcatheter left atrial appendage occlusion (LAAO) versus direct oral anticoagulants (DOACs). This algorithm can help patients with atrial fibrillation (AFib) who need to be referred to a subspecialty for consultation. The findings were published in JACC: Clinical Electrophysiology. <Read More>

Costco to Not Sell Abortion Pill Mifepristone at its US Pharmacy Stores – August 15, 2025 – Costco Wholesale (COST.O), opens new tab said on Thursday it has decided to not sell abortion pill mifepristone across all its U.S. pharmacy stores, citing low demand. "Our position at this time not to sell mifepristone, which has not changed, is based on the lack of demand from our members and other patients, who we understand generally have the drug dispensed by their medical providers," Costco said. The decision comes amid campaigns against the pill by religious activist groups, including Inspire Investing and Alliance Defending Freedom. <Read More> 

House, Senate Bills Would Expand Pharmacists’ Scope of Practice – August 14, 2025 – H.R. 3164, the Ensuring Community Access to Pharmacist Services Act, has been sponsored by Rep. Adrian Smith (R-Neb.). The bill would amend the Social Security Act to allow Medicare payment for pharmacists to evaluate, diagnose and treat patients for a range of illnesses including COVID-19, respiratory syncytial virus (RSV) and streptococcal pharyngitis. The measure also would let pharmacists test and treat patients in response to an unspecified “public health need” related to a public health emergency. <Read More> 

Eli Lilly Accused of Bribing Providers to Prescribe GLP-1RA Drugs – August 13, 2025 – Despite posting record Q2 growth for its blockbuster weight loss and diabetes drug tirzepatide, Eli Lilly is facing legal challenge from a lawsuit filed in Texas that accuses the pharma company of bribing providers to prescribe its drugs.  Attorney General for Texas Ken Paxton and Health Choice Alliance claim Eli Lilly “offered illegal incentives” to medical providers in the southern state so its most profitable drugs, including popular glucagon-like peptide-1 receptor agonist (GLP-1RA) medications tirzepatide, marketed as Mounjaro® and Zepbound®, would be preferentially prescribed to patients. <Read More> 

An AI “Copilot” Can Reduce Prescription Errors That Put Patients at Risk – August 12, 2025 – “Take two aspirin and call me in the morning.” If only prescribing medications were as simple as that. In reality, the prescription process involves many players and steps. Details must be accurately spelled out, interpreted, and double-checked to ensure patients get the correct drug and dosage…With several collaborators at Amazon, Bayati developed an AI-based system for translating prescriptions with fewer errors. “An AI approach to this problem is a good choice because it’s capable of seeing patterns in prescription data and could flag prescriptions that match error-related patterns and write error-free ones,” Bayati says. <Read More>

340B in the News

AHA Accuses Drug Companies of Colluding to Impose 340B Rebate Plans – September 9, 2025 – The country’s largest hospital lobby is accusing five major drugmakers of secretly conspiring to transition to a rebate model in 340B, in the latest salvo between providers and pharmaceutical companies over the future of the drug discount program. On Monday, the American Hospital Association sent a letter to the heads of the Federal Trade Commission and the Justice Department’s antitrust division asking them to investigate Johnson & Johnson, Eli Lilly, Bristol Myers Squibb, Sanofi and Novartis for potential collusion. <Read More>

CBO Confirms 340B Drug Pricing Program Increases Costs for Federal Taxpayers – September 9, 2025 –  Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, issued the following statement in response to the Congressional Budget Office’s (CBO) report released September 9th, which confirmed the 340B Drug Pricing Program encourages behaviors that increase federal spending and raise prices for American taxpayers. Some of those behaviors include incentivizing the prescription of more expensive drugs, reducing negotiated rebates for insurers, and increasing vertical integration among facilities. <Read More> 

Read More

Clinical Insights: September 10th, 2025

New Drug/Vaccine Approval

Wayrilz™ (rilzabrutinib) Tablets – New Drug Approval – August 28, 2025 – The US Food and Drug Administration (FDA) has approved Wayrilz™ (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The approval was based on the pivotal LUNA 3 phase 3 study, in which Wayrilz™ met the primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms. <Read More>

Dawnzera™ (donidalorsen) Injection – New Drug Approval – August 21, 2025 – Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has approved Dawnzera™ (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. Dawnzera™ is the first and only RNA-targeted medicine approved for HAE, designed to target plasma prekallikrein (PKK), a key protein that activates inflammatory mediators associated with acute attacks of HAE. Dawnzera™ 80mg is self-administered via subcutaneous autoinjector once every four (Q4W) or eight weeks (Q8W). <Read More> 

Tonmya™ (cyclobenzaprine hydrochloride) - formerly TNX-102 SL – New Drug Approval – August 15, 2025 – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company, announced that the U.S. Food and Drug Administration (FDA) approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Tonmya™ is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual (under the tongue) formulation that is designed for rapid absorption into the bloodstream. Tonmya™ is the first new FDA-approved therapy for the treatment of fibromyalgia in over 15 years. <Read More>

Papzimeos™ (zopapogene imadenovec-drba) Injection – New Drug Approval – August 14, 2025 – Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, announced that the US Food and Drug Administration (FDA) has approved Papzimeos™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). Papzimeos™ is the first and only FDA-approved therapy for the treatment of adults with RRP. Precigen completed submission of the rolling Biologics License Application (BLA) in December 2024 under an accelerated approval pathway; however, the FDA has granted Papzimeos™ full approval, which does not require a confirmatory clinical trial. Papzimeos™ is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins—the root cause of RRP. Papzimeos™ is delivered via four subcutaneous injections over a 12-week interval. <Read More>

Brinsupri™ (brensocatib) Tablets – New Drug Approval – August 12, 2025 – Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, announced that the U.S. Food and Drug Administration (FDA) has approved first-in-class Brinsupri™ (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. Brinsupri™ is the first and only FDA-approved treatment for NCFB, giving hundreds of thousands of patients and clinicians across the U.S. an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline. <Read More> 

Hernexeos® (zongertinib) Tablets – New Drug Approval – August 8, 2025 – Boehringer Ingelheim’s Hernexeos® (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA). The kinase inhibitor is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. <Read More>  

KETARx™ (ketamine hydrochloride) Injection – New Drug Approval – August 7, 2025 – PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, announced the advancement of its ketamine transdermal patch as a next-generation, non-opioid pain relief solution, building on the recent FDA approval of its IV ketamine product (KETARx™). <Read More> 

Modeyso™ (dordaviprone) Capsules – New Drug Approval – August 6, 2025 – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the Phase 3 ACTION confirmatory trial. <Read More>

New Label Expansions

Leqembi® (lecanemab-irmb) Injection – New Label Expansion – August 29, 2025 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab-irmb subcutaneous injection (U.S. brand name: Leqembi® Iqlik™, pronounced "I Click") for maintenance dosing. Leqembi® Iqlik™ is a subcutaneous autoinjector (SC-AI) developed by Eisai, containing 360 mg/1.8 mL (200 mg/mL) that can be administered in approximately 15 seconds. <Read More> 

Comirnaty® (COVID-19 Vaccine, mRNA) Injection – New Label Expansion – August 27, 2025 – Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (Comirnaty® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. <Read More>

Filspari® (sparsentan) Tablets – New Label Expansion – August 27, 2025 – Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that the U.S. Food and Drug Administration (FDA) has approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for Filspari® (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist for the treatment of IgA nephropathy (IgAN). <Read More> 

mNEXSPIKE® (COVID-19 Vaccine, mRNA) Injection – New Label Expansion – August 27, 2025 – Moderna, Inc. (NASDAQ:MRNA) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax® and mNEXSPIKE®, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. <Read More> 

Nuvaxovid™ (COVID-19 Vaccine, Adjuvanted) Injectable Suspension – New Label Expansion – August 27, 2025 – Novavax, Inc. (Nasdaq: NVAX) announced that the U.S. Food and Drug Administration has approved the Nuvaxovid™ 2025-2026 Formula for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. <Read More> 

Repatha® (evolocumab) Injection – New Label Expansion – August 21, 2025 – Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), commonly known as 'bad cholesterol.' The update removes a prior requirement for a patient to have been diagnosed with cardiovascular (CV) disease. <Read More> 

Wegovy® (semaglutide) Injection – New Label Expansion – August 15, 2025 – The U.S. Food and Drug Administration has approved Wegovy® (semaglutide) injection to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis (excessive scar tissue in the liver). MASH, also known as nonalcoholic steatohepatitis, is a serious liver disease. Wegovy®, which was first approved in 2017, is also approved for obesity or overweight and to reduce cardiovascular events, such as heart attacks, in individuals at high risk of these events. Approximately 6% of U.S. adults (14.9 million people) have MASH, and its prevalence is expanding. <Read More> 

Ajovy® (fremanezumab-vfrm) Injection – New Label Expansion – August 5, 2025 – Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced that the U.S. Food and Drug Administration (FDA) has approved Ajovy® for the preventive treatment of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. <Read More> 

New Drug Shortage

September 8, 2025

September 4, 2025

August 29, 2025

August 27, 2025

August 25, 2025

Updated Drug Shortage

September 5, 2025

September 4, 2025

September 3, 2025

September 2, 2025

August 29, 2025

New Drug Recall and Safety Alerts

Cyclobenzaprine Hydrochloride Tablets USP 10 mg by Unichem Pharmaceuticals (USA) Inc. – New Voluntary Recall – August 27, 2025 – Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam 7.5 mg tablets. <Read More> 

Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL by B. Braun Medical – New Voluntary Recall  – August 19, 2025 - B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL, and 0.9% Sodium Chloride Injection USP 1000 mL to the hospital level due to the presence of particulate matter inside the container. B. Braun has identified through complaints the potential for the product to contain particulate matter in solution. To date there have been no reports of serious injury, death or other adverse events associated with this issue. <Read More> 

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Walgreens Shakeup Sparks Patient Fear as Pharmacies Face More Closures After 295 Shutters – September 8, 2025 – A few months after a definitive agreement signing in March, Walgreens has been officially purchased by private equity firm Sycamore Partners for $10 billion, per a press release. Part of the deal means that Walgreens Boots Alliance and its subsidiaries are split into five separate and privately-owned operations… While the $10 billion was heavily supported by Walgreens shareholders, some industry experts worry that this decision will ultimately lead to more layoffs and closures for the brand, per what they told Healthcare Brew. <Read More>

A Pharmacy Benefit Manager Stopped Covering a GLP-1 for Obesity. Now There’s a Lawsuit – September 6, 2025 – A class-action lawsuit has been filed against CVS Caremark over its decision to stop covering Zepbound®, Eli Lilly’s blockbuster GLP-1 drug to treat obesity. When the major pharmacy benefit manager informed patients about the change this year, it suggested that there was “another covered medication that’s safe and effective for your condition and may cost less”: namely Wegovy®, from Novo Nordisk, with which CVS Caremark announced a partnership just before the change took effect. <Read More> 

The Five Biggest Challenges Facing Retail Pharmacy – August 28, 2025 – Retail pharmacy operators face an array of challenges beyond PBM reform, which many observers say remains the single biggest obstacle to operating successfully in today’s environment. Among the most pressing issues is how the Medicare price negotiations that were included in the Inflation Reduction Act will play out at the retail level. Many retailers are concerned that reimbursement mechanisms might not be adequate to support their cash flow needs. In addition, the reimbursement models that evolve for GLP-1 drugs and other high-cost medications could also pose challenges for retailers. <Read More>

Getting a Covid Shot This Fall Could be a lot More Complicated – August 22, 2025 – The millions of Americans who are used to getting their Covid-19 vaccines at a local pharmacy may face new hurdles this fall depending on where they live and whether federal health officials have decided they qualify. Pharmacists’ authority to vaccinate individuals varies across state lines. In some places, it’s dependent upon a federal advisory process that Health Secretary Robert F. Kennedy Jr. has upended. <Read More> 

Determining if LAAO Will Benefit Patients With Afib Using Novel AI Algorithm – August 16, 2025 – Researchers in Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery in collaboration with Cardiovascular Medicine developed a new artificial intelligence (AI) algorithm to identify patients likely to benefit from transcatheter left atrial appendage occlusion (LAAO) versus direct oral anticoagulants (DOACs). This algorithm can help patients with atrial fibrillation (AFib) who need to be referred to a subspecialty for consultation. The findings were published in JACC: Clinical Electrophysiology. <Read More>

Costco to Not Sell Abortion Pill Mifepristone at its US Pharmacy Stores – August 15, 2025 – Costco Wholesale (COST.O), opens new tab said on Thursday it has decided to not sell abortion pill mifepristone across all its U.S. pharmacy stores, citing low demand. "Our position at this time not to sell mifepristone, which has not changed, is based on the lack of demand from our members and other patients, who we understand generally have the drug dispensed by their medical providers," Costco said. The decision comes amid campaigns against the pill by religious activist groups, including Inspire Investing and Alliance Defending Freedom. <Read More> 

House, Senate Bills Would Expand Pharmacists’ Scope of Practice – August 14, 2025 – H.R. 3164, the Ensuring Community Access to Pharmacist Services Act, has been sponsored by Rep. Adrian Smith (R-Neb.). The bill would amend the Social Security Act to allow Medicare payment for pharmacists to evaluate, diagnose and treat patients for a range of illnesses including COVID-19, respiratory syncytial virus (RSV) and streptococcal pharyngitis. The measure also would let pharmacists test and treat patients in response to an unspecified “public health need” related to a public health emergency. <Read More> 

Eli Lilly Accused of Bribing Providers to Prescribe GLP-1RA Drugs – August 13, 2025 – Despite posting record Q2 growth for its blockbuster weight loss and diabetes drug tirzepatide, Eli Lilly is facing legal challenge from a lawsuit filed in Texas that accuses the pharma company of bribing providers to prescribe its drugs.  Attorney General for Texas Ken Paxton and Health Choice Alliance claim Eli Lilly “offered illegal incentives” to medical providers in the southern state so its most profitable drugs, including popular glucagon-like peptide-1 receptor agonist (GLP-1RA) medications tirzepatide, marketed as Mounjaro® and Zepbound®, would be preferentially prescribed to patients. <Read More> 

An AI “Copilot” Can Reduce Prescription Errors That Put Patients at Risk – August 12, 2025 – “Take two aspirin and call me in the morning.” If only prescribing medications were as simple as that. In reality, the prescription process involves many players and steps. Details must be accurately spelled out, interpreted, and double-checked to ensure patients get the correct drug and dosage…With several collaborators at Amazon, Bayati developed an AI-based system for translating prescriptions with fewer errors. “An AI approach to this problem is a good choice because it’s capable of seeing patterns in prescription data and could flag prescriptions that match error-related patterns and write error-free ones,” Bayati says. <Read More>

340B in the News

AHA Accuses Drug Companies of Colluding to Impose 340B Rebate Plans – September 9, 2025 – The country’s largest hospital lobby is accusing five major drugmakers of secretly conspiring to transition to a rebate model in 340B, in the latest salvo between providers and pharmaceutical companies over the future of the drug discount program. On Monday, the American Hospital Association sent a letter to the heads of the Federal Trade Commission and the Justice Department’s antitrust division asking them to investigate Johnson & Johnson, Eli Lilly, Bristol Myers Squibb, Sanofi and Novartis for potential collusion. <Read More>

CBO Confirms 340B Drug Pricing Program Increases Costs for Federal Taxpayers – September 9, 2025 –  Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, issued the following statement in response to the Congressional Budget Office’s (CBO) report released September 9th, which confirmed the 340B Drug Pricing Program encourages behaviors that increase federal spending and raise prices for American taxpayers. Some of those behaviors include incentivizing the prescription of more expensive drugs, reducing negotiated rebates for insurers, and increasing vertical integration among facilities. <Read More> 

Read More

Clinical Insights: September 10th, 2025

New Drug/Vaccine Approval

Wayrilz™ (rilzabrutinib) Tablets – New Drug Approval – August 28, 2025 – The US Food and Drug Administration (FDA) has approved Wayrilz™ (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The approval was based on the pivotal LUNA 3 phase 3 study, in which Wayrilz™ met the primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms. <Read More>

Dawnzera™ (donidalorsen) Injection – New Drug Approval – August 21, 2025 – Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has approved Dawnzera™ (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. Dawnzera™ is the first and only RNA-targeted medicine approved for HAE, designed to target plasma prekallikrein (PKK), a key protein that activates inflammatory mediators associated with acute attacks of HAE. Dawnzera™ 80mg is self-administered via subcutaneous autoinjector once every four (Q4W) or eight weeks (Q8W). <Read More> 

Tonmya™ (cyclobenzaprine hydrochloride) - formerly TNX-102 SL – New Drug Approval – August 15, 2025 – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company, announced that the U.S. Food and Drug Administration (FDA) approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Tonmya™ is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual (under the tongue) formulation that is designed for rapid absorption into the bloodstream. Tonmya™ is the first new FDA-approved therapy for the treatment of fibromyalgia in over 15 years. <Read More>

Papzimeos™ (zopapogene imadenovec-drba) Injection – New Drug Approval – August 14, 2025 – Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, announced that the US Food and Drug Administration (FDA) has approved Papzimeos™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). Papzimeos™ is the first and only FDA-approved therapy for the treatment of adults with RRP. Precigen completed submission of the rolling Biologics License Application (BLA) in December 2024 under an accelerated approval pathway; however, the FDA has granted Papzimeos™ full approval, which does not require a confirmatory clinical trial. Papzimeos™ is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins—the root cause of RRP. Papzimeos™ is delivered via four subcutaneous injections over a 12-week interval. <Read More>

Brinsupri™ (brensocatib) Tablets – New Drug Approval – August 12, 2025 – Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, announced that the U.S. Food and Drug Administration (FDA) has approved first-in-class Brinsupri™ (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. Brinsupri™ is the first and only FDA-approved treatment for NCFB, giving hundreds of thousands of patients and clinicians across the U.S. an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline. <Read More> 

Hernexeos® (zongertinib) Tablets – New Drug Approval – August 8, 2025 – Boehringer Ingelheim’s Hernexeos® (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA). The kinase inhibitor is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. <Read More>  

KETARx™ (ketamine hydrochloride) Injection – New Drug Approval – August 7, 2025 – PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, announced the advancement of its ketamine transdermal patch as a next-generation, non-opioid pain relief solution, building on the recent FDA approval of its IV ketamine product (KETARx™). <Read More> 

Modeyso™ (dordaviprone) Capsules – New Drug Approval – August 6, 2025 – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the Phase 3 ACTION confirmatory trial. <Read More>

New Label Expansions

Leqembi® (lecanemab-irmb) Injection – New Label Expansion – August 29, 2025 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab-irmb subcutaneous injection (U.S. brand name: Leqembi® Iqlik™, pronounced "I Click") for maintenance dosing. Leqembi® Iqlik™ is a subcutaneous autoinjector (SC-AI) developed by Eisai, containing 360 mg/1.8 mL (200 mg/mL) that can be administered in approximately 15 seconds. <Read More> 

Comirnaty® (COVID-19 Vaccine, mRNA) Injection – New Label Expansion – August 27, 2025 – Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (Comirnaty® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. <Read More>

Filspari® (sparsentan) Tablets – New Label Expansion – August 27, 2025 – Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that the U.S. Food and Drug Administration (FDA) has approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for Filspari® (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist for the treatment of IgA nephropathy (IgAN). <Read More> 

mNEXSPIKE® (COVID-19 Vaccine, mRNA) Injection – New Label Expansion – August 27, 2025 – Moderna, Inc. (NASDAQ:MRNA) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax® and mNEXSPIKE®, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. <Read More> 

Nuvaxovid™ (COVID-19 Vaccine, Adjuvanted) Injectable Suspension – New Label Expansion – August 27, 2025 – Novavax, Inc. (Nasdaq: NVAX) announced that the U.S. Food and Drug Administration has approved the Nuvaxovid™ 2025-2026 Formula for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. <Read More> 

Repatha® (evolocumab) Injection – New Label Expansion – August 21, 2025 – Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), commonly known as 'bad cholesterol.' The update removes a prior requirement for a patient to have been diagnosed with cardiovascular (CV) disease. <Read More> 

Wegovy® (semaglutide) Injection – New Label Expansion – August 15, 2025 – The U.S. Food and Drug Administration has approved Wegovy® (semaglutide) injection to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis (excessive scar tissue in the liver). MASH, also known as nonalcoholic steatohepatitis, is a serious liver disease. Wegovy®, which was first approved in 2017, is also approved for obesity or overweight and to reduce cardiovascular events, such as heart attacks, in individuals at high risk of these events. Approximately 6% of U.S. adults (14.9 million people) have MASH, and its prevalence is expanding. <Read More> 

Ajovy® (fremanezumab-vfrm) Injection – New Label Expansion – August 5, 2025 – Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced that the U.S. Food and Drug Administration (FDA) has approved Ajovy® for the preventive treatment of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. <Read More> 

New Drug Shortage

September 8, 2025

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August 29, 2025

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August 25, 2025

Updated Drug Shortage

September 5, 2025

September 4, 2025

September 3, 2025

September 2, 2025

August 29, 2025

New Drug Recall and Safety Alerts

Cyclobenzaprine Hydrochloride Tablets USP 10 mg by Unichem Pharmaceuticals (USA) Inc. – New Voluntary Recall – August 27, 2025 – Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam 7.5 mg tablets. <Read More> 

Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL by B. Braun Medical – New Voluntary Recall  – August 19, 2025 - B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL, and 0.9% Sodium Chloride Injection USP 1000 mL to the hospital level due to the presence of particulate matter inside the container. B. Braun has identified through complaints the potential for the product to contain particulate matter in solution. To date there have been no reports of serious injury, death or other adverse events associated with this issue. <Read More> 

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Walgreens Shakeup Sparks Patient Fear as Pharmacies Face More Closures After 295 Shutters – September 8, 2025 – A few months after a definitive agreement signing in March, Walgreens has been officially purchased by private equity firm Sycamore Partners for $10 billion, per a press release. Part of the deal means that Walgreens Boots Alliance and its subsidiaries are split into five separate and privately-owned operations… While the $10 billion was heavily supported by Walgreens shareholders, some industry experts worry that this decision will ultimately lead to more layoffs and closures for the brand, per what they told Healthcare Brew. <Read More>

A Pharmacy Benefit Manager Stopped Covering a GLP-1 for Obesity. Now There’s a Lawsuit – September 6, 2025 – A class-action lawsuit has been filed against CVS Caremark over its decision to stop covering Zepbound®, Eli Lilly’s blockbuster GLP-1 drug to treat obesity. When the major pharmacy benefit manager informed patients about the change this year, it suggested that there was “another covered medication that’s safe and effective for your condition and may cost less”: namely Wegovy®, from Novo Nordisk, with which CVS Caremark announced a partnership just before the change took effect. <Read More> 

The Five Biggest Challenges Facing Retail Pharmacy – August 28, 2025 – Retail pharmacy operators face an array of challenges beyond PBM reform, which many observers say remains the single biggest obstacle to operating successfully in today’s environment. Among the most pressing issues is how the Medicare price negotiations that were included in the Inflation Reduction Act will play out at the retail level. Many retailers are concerned that reimbursement mechanisms might not be adequate to support their cash flow needs. In addition, the reimbursement models that evolve for GLP-1 drugs and other high-cost medications could also pose challenges for retailers. <Read More>

Getting a Covid Shot This Fall Could be a lot More Complicated – August 22, 2025 – The millions of Americans who are used to getting their Covid-19 vaccines at a local pharmacy may face new hurdles this fall depending on where they live and whether federal health officials have decided they qualify. Pharmacists’ authority to vaccinate individuals varies across state lines. In some places, it’s dependent upon a federal advisory process that Health Secretary Robert F. Kennedy Jr. has upended. <Read More> 

Determining if LAAO Will Benefit Patients With Afib Using Novel AI Algorithm – August 16, 2025 – Researchers in Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery in collaboration with Cardiovascular Medicine developed a new artificial intelligence (AI) algorithm to identify patients likely to benefit from transcatheter left atrial appendage occlusion (LAAO) versus direct oral anticoagulants (DOACs). This algorithm can help patients with atrial fibrillation (AFib) who need to be referred to a subspecialty for consultation. The findings were published in JACC: Clinical Electrophysiology. <Read More>

Costco to Not Sell Abortion Pill Mifepristone at its US Pharmacy Stores – August 15, 2025 – Costco Wholesale (COST.O), opens new tab said on Thursday it has decided to not sell abortion pill mifepristone across all its U.S. pharmacy stores, citing low demand. "Our position at this time not to sell mifepristone, which has not changed, is based on the lack of demand from our members and other patients, who we understand generally have the drug dispensed by their medical providers," Costco said. The decision comes amid campaigns against the pill by religious activist groups, including Inspire Investing and Alliance Defending Freedom. <Read More> 

House, Senate Bills Would Expand Pharmacists’ Scope of Practice – August 14, 2025 – H.R. 3164, the Ensuring Community Access to Pharmacist Services Act, has been sponsored by Rep. Adrian Smith (R-Neb.). The bill would amend the Social Security Act to allow Medicare payment for pharmacists to evaluate, diagnose and treat patients for a range of illnesses including COVID-19, respiratory syncytial virus (RSV) and streptococcal pharyngitis. The measure also would let pharmacists test and treat patients in response to an unspecified “public health need” related to a public health emergency. <Read More> 

Eli Lilly Accused of Bribing Providers to Prescribe GLP-1RA Drugs – August 13, 2025 – Despite posting record Q2 growth for its blockbuster weight loss and diabetes drug tirzepatide, Eli Lilly is facing legal challenge from a lawsuit filed in Texas that accuses the pharma company of bribing providers to prescribe its drugs.  Attorney General for Texas Ken Paxton and Health Choice Alliance claim Eli Lilly “offered illegal incentives” to medical providers in the southern state so its most profitable drugs, including popular glucagon-like peptide-1 receptor agonist (GLP-1RA) medications tirzepatide, marketed as Mounjaro® and Zepbound®, would be preferentially prescribed to patients. <Read More> 

An AI “Copilot” Can Reduce Prescription Errors That Put Patients at Risk – August 12, 2025 – “Take two aspirin and call me in the morning.” If only prescribing medications were as simple as that. In reality, the prescription process involves many players and steps. Details must be accurately spelled out, interpreted, and double-checked to ensure patients get the correct drug and dosage…With several collaborators at Amazon, Bayati developed an AI-based system for translating prescriptions with fewer errors. “An AI approach to this problem is a good choice because it’s capable of seeing patterns in prescription data and could flag prescriptions that match error-related patterns and write error-free ones,” Bayati says. <Read More>

340B in the News

AHA Accuses Drug Companies of Colluding to Impose 340B Rebate Plans – September 9, 2025 – The country’s largest hospital lobby is accusing five major drugmakers of secretly conspiring to transition to a rebate model in 340B, in the latest salvo between providers and pharmaceutical companies over the future of the drug discount program. On Monday, the American Hospital Association sent a letter to the heads of the Federal Trade Commission and the Justice Department’s antitrust division asking them to investigate Johnson & Johnson, Eli Lilly, Bristol Myers Squibb, Sanofi and Novartis for potential collusion. <Read More>

CBO Confirms 340B Drug Pricing Program Increases Costs for Federal Taxpayers – September 9, 2025 –  Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, issued the following statement in response to the Congressional Budget Office’s (CBO) report released September 9th, which confirmed the 340B Drug Pricing Program encourages behaviors that increase federal spending and raise prices for American taxpayers. Some of those behaviors include incentivizing the prescription of more expensive drugs, reducing negotiated rebates for insurers, and increasing vertical integration among facilities. <Read More> 

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Clinical Insights: August 6th, 2025

New Drug/Vaccine Approval

Vizz™ (aceclidine) Ophthalmic Solution - formerly LNZ100 – New Drug Approval – July 31, 2025 – LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), announced the US Food and Drug Administration (“FDA”) approved Vizz™ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults. Samples are anticipated in the United States as early as October 2025, with commercial product to be broadly available by mid-Q4 2025. Direct-to-eye care professional sales and marketing activities to be initiated immediately. <Read More>

Sephience™ (sepiapterin) Oral Powder – New Drug Approval – July 28, 2025 - PTC Therapeutics, Inc. (NASDAQ: PTCT) announced that the U.S. Food and Drug Administration (FDA) has approved Sephience™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). The approval includes broad labeling for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive PKU. <Read More> 

Anzupgo® (delgocitinib) Topical Cream - New Drug Approval – July 23, 2025 - LEO Pharma, a global leader in medical dermatology, announced that the U.S. Food and Drug Administration (FDA) has approved Anzupgo® (delgocitinib) cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Anzupgo® is an innovative steroid-free, topical pan-Janus kinase (JAK) inhibitor for adults with CHE. <Read More>

New Label Expansions

Alhemo® (concizumab-mtci) Injection – New Label Expansion – July 31, 2025 – The U.S. Food and Drug Administration has approved Alhemo® (concizumab-mtci) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. Alhemo® is injected subcutaneously (under the skin) daily. <Read More> 

Leqvio® (inclisiran) Injection - New Label Expansion – July 31, 2025 - Novartis announced that the US Food and Drug Administration (FDA) has approved a label update for Leqvio® (inclisiran), enabling its use as monotherapy along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. The FDA proactively requested the label update based on the robust LDL-C lowering data for PCSK9-targeting therapies. <Read More>

Biktarvy® (bictegravir, emtricitabine and tenofovir alafenamide) Tablets - New Label Expansion – July 30, 2025 - Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has granted a new approval for a novel indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF). This new indication expands Biktarvy®’s label to include the treatment of people with HIV (PWH) with an antiretroviral treatment (ART) history who are not virologically suppressed, with no known or suspected resistance to the integrase strand inhibitor (INSTI) class, emtricitabine or tenofovir. <Read More> 

Empaveli® (pegcetacoplan) Injection - New Label Expansion – July 28, 2025 - Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced that the U.S. Food and Drug Administration (FDA) has approved Empaveli® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. C3G and primary IC-MPGN are rare kidney diseases, affecting 5,000 people in the United States. <Read More>

Skytrofa® (lonapegsomatropin-tcgd) Lyophilized Powder for Injection – New Label Expansion – July 28, 2025 - Ascendis Pharma A/S (Nasdaq: ASND) announced that the U.S. Food & Drug Administration (FDA) has approved Skytrofa® (lonapegsomatropin-tcgd; developed as TransCon hGH) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD), a rare disorder resulting from decreased or total loss of growth hormone production. Lonapegsomatropin (approved by the FDA in 2021 for the treatment of pediatric GHD) is a prodrug of somatropin (human growth hormone, or hGH) administered once weekly, providing sustained release of active, unmodified somatropin. <Read More> 

Doptelet® (avatrombopag) Tablets and Oral Granules - New Label Expansion – July 25, 2025 - Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), announced that the U.S. Food and Drug Administration (FDA) approved Doptelet® (avatrombopag) for the treatment of thrombocytopenia in pediatric patients one year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a prior therapy.  The approval also includes a new formulation, Doptelet® Sprinkle (avatrombopag) oral granules, for use in children ages one to less than six years. <Read More>

Shingrix® (zoster vaccine recombinant, adjuvanted) Injection - New Label Expansion – July 17, 2025 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved a prefilled syringe presentation of Shingrix® (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster). The new prefilled syringe removes the need to reconstitute separate vials prior to administration, simplifying the vaccine administration process for healthcare professionals. <Read More> 

Kerendia® (finerenone) Tablets - New Label Expansion – July 14, 2025 - Bayer announced that the U.S. Food and Drug Administration (FDA) approved Kerendia® (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, following the agency’s Priority Review of its supplemental New Drug Application (sNDA). <Read More>

Spikevax® (Moderna COVID-19 Vaccine) (COVID-19 Vaccine, mRNA) Injection - New Label Expansion – July 10, 2025 - Moderna, Inc. (NASDAQ:MRNA) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax®, the Company's COVID-19 vaccine, in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. The Company's COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under Emergency Use Authorization (EUA). <Read More> 

Kisunla™ (donanemab-azbt) Injection - New Label Expansion – July 9, 2025 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla™ (donanemab-azbt), Lilly's once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people in the mild dementia stage of AD, with confirmed amyloid pathology. In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) versus the original dosing schedule at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction. <Read More>

New Drug Shortage

August 4, 2025

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July 21, 2025

July 17, 2025

Updated Drug Shortage

August 4, 2025

August 1, 2025

July 31, 2025

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July 22, 2025

July 18, 2025

July 17, 2025

New Drug Recall and Safety Alerts

Sucralfate Tablets USP 1 Gram by Nostrum Laboratories, Inc. – New Voluntary Recall – July 14, 2025 – Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfate Tablets USP 1 gram, all lots within expiry, as a result of the closures and discontinuation of its Quality activities. This recall pertains only to Sucralfate Tablets USP 1 gram, all lots with expiry, manufactured by Nostrum Labs after June 2023. <Read More> 

New Generic/Biosimilar Approval and Launch

Kirsty™ (insulin aspart-xjhz) Injection - New NovoLog® Biosimilar Approval – July 15, 2025 - Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Kirsty™ (Insulin Aspart-xjhz), 100 units/mL as the first and only interchangeable biosimilar to NovoLog® (Insulin Aspart). Kirsty™ is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Kirsty™ will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use. <Read More>

Clinical and Pharmacy News

PBM Markets are at Risk of Harming Patients – July 31, 2025 – The American Medical Association (AMA) published a new annual analysis (PDF) measuring competition in pharmacy benefit manager (PBM) markets and vertical integration of insurers with PBMs. The assessment demonstrates low competition in PBM markets across the nation and high vertical integration as the largest PBMs share ownership with health insurers. The AMA analysis adds to growing concern over anticompetitive harm resulting from low competition and high vertical integration in the PBM industry. It comes on the heels of reports by the Federal Trade Commission and U.S. House Committee on Oversight and Accountability finding that a handful of PBMs have vast power and control over medication access and affordability. <Read More> 

First Guideline on Alzheimer’s Blood-Based Biomarker Tests Released – July 31, 2025 – An expert panel convened by the Alzheimer’s Association has released the first clinical guidelines to help clinicians choose the most appropriate blood-based biomarker (BBM) test to aid in the diagnosis of Alzheimer’s disease (AD). The evidence-based guideline recommends that tests with ≥ 90% sensitivity and specificity can serve as a substitute for amyloid PET or cerebrospinal fluid (CSF) biomarker testing. Tests with ≥ 90% sensitivity but only ≥ 75% specificity should be used as a triaging test. In this case, a negative result rules out AD pathology with high probability and a positive result should be confirmed with CSF or PET testing. <Read More>

This Year’s Prescription Drug Bills Aim to Reduce Consumer Costs – July 30, 2025 – More than 800 prescription drug access and affordability proposals were introduced across all 50 states, Washington, D.C., and the territories in this year’s legislative sessions. The more than 130 enacted bills included some familiar policies as well as some new ones. Lawmakers were looking for ways to hold costs down through pharmacy benefit manager (PBM) reform, with more than 40 states considering some 270 PBM-related bills. Several themes emerged, including  Prohibiting spread pricing. States may enter contractual arrangements with PBMs to administer state employee health plan and Medicaid prescription benefits. Spread pricing, which is a traditional PBM business model, is a contractual agreement where an insurer or employer pays a higher amount for a prescription drug than the PBM reimbursement to the pharmacy. The PBM then keeps a portion of the spread. Regulating agencies in several states have raised concerns over the spread PBMs retain. <Read More> 

Drugmaker Novo Nordisk Slashes Wegovy® Sales Forecasts, Blaming Compounding – July 29, 2025 – Novo Nordisk's shares plunged more than 20% Tuesday, after the company cut the forecast for its flagship obesity drug. Before the markets opened, the company announced that sales of its obesity medicine, Wegovy®, are expected to grow no more than 14% this year. That's down from its prediction of up to 21% on May 7. The company blames cheaper alternatives made by compounding pharmacies, which are allowed to make what are essentially copies of drugs when they're in short supply. Wegovy® and Ozempic®, a diabetes drug sometimes prescribed for weight loss, had been on the Food and Drug Administration's drug shortage list, paving the way for a boom in compounded versions. <Read More> 

Delinking Pharmacy Benefit Manager Compensation From Drug List Prices Could Unleash Major Savings – July 24, 2025 – Breaking the link between prescription drug list prices and compensation to middlemen like pharmacy benefit managers (PBMs) could cut a significant portion of the U.S.'s annual drug tab, finds a new analysis from the USC Schaeffer Center for Health Policy & Economics. The work is published in the journal Health Affairs Scholar. PBMs, who negotiate drug benefits on behalf of insurers and employers, are typically paid based on a percentage of a drug's list price before rebates and other discounts are applied. Federal and state policymakers have proposed delinking PBM compensation from list prices in response to evidence that PBMs often steer patients toward higher-priced drugs—even when cheaper alternatives are available—to boost their own profits. <Read More> 

New Biosimilars Metric Confirms Switching Efficacy – July 23, 2025 – Most patients who were switched from adalimumab (Humira®, AbbVie) to an interchangeable biosimilar experienced clinical success, with the vast majority remaining on a biosimilar three months after conversion, according to a study conducted at Brown University Health and presented in a poster (38-M) at the ASHP Pharmacy Futures 2025 meeting. The study used data from the center’s electronic health records and specialty pharmacy from Jan. 1, 2023, to June 1, 2024. The primary objective was to evaluate the rate of reversion to the reference product three months after a payor mandated a switch to a biosimilar. <Read More>

Specialty Pharmacies Can Dispense the Emotional Script to Support Patients – July 23, 2025 – Behind every specialty medication is a person facing uncertainty. As this market surges toward unprecedented growth over the next decade, specialty pharmacies are increasingly turning to automation to meet demand and manage costs. However, while efficiency metrics climb, something essential gets lost—the human experience. Specialty pharmacies that prioritize efficiency over empathy risk missing what matters most: meaningful connection during a critical moment in care. Research suggests that adherence may be influenced not only by logistical or clinical barriers but also by emotional and psychological factors, such as fear, uncertainty, and loneliness. <Read More> 

HHS and Private Health Insurers Team Up to Improve Prior Authorization Process – July 14, 2025 - Stakeholders from federal health agencies and leading payors have pledged to streamline the often burdensome prior authorization process that can lead to delays in treatment and poorer clinical outcomes. The new pledge, by America’s Health Insurance Plans (AHIP), a trade organization representing many health insurance companies, was at the center of a recent roundtable discussion that AHIP held with Health and Human Services Secretary Robert F. Kennedy Jr., and Mehmet Oz, MD, the administrator of the  Centers for Medicare & Medicaid Services (CMS). <Read More> 

340B in the News

HHS Announces New 340B Rebate Model Pilot Program – July 31, 2025 – The Department of Health and Human Services issued a notice announcing a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all 340B-covered entities. The notice said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, is inviting certain drug manufacturers to apply for participation in the pilot program for a minimum of one year. HRSA said the pilot program will be limited to the NDC-11s included on the Centers for Medicare & Medicaid Services’ Medicare Drug Price Negotiation Selected Drug List regardless of payer. HRSA said manufacturers must submit applications to participate in the pilot program by Sept. 15, and approvals will be made by Oct. 15 for a Jan. 1, 2026, effective date. <Read More> 


Read More

Clinical Insights: August 6th, 2025

New Drug/Vaccine Approval

Vizz™ (aceclidine) Ophthalmic Solution - formerly LNZ100 – New Drug Approval – July 31, 2025 – LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), announced the US Food and Drug Administration (“FDA”) approved Vizz™ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults. Samples are anticipated in the United States as early as October 2025, with commercial product to be broadly available by mid-Q4 2025. Direct-to-eye care professional sales and marketing activities to be initiated immediately. <Read More>

Sephience™ (sepiapterin) Oral Powder – New Drug Approval – July 28, 2025 - PTC Therapeutics, Inc. (NASDAQ: PTCT) announced that the U.S. Food and Drug Administration (FDA) has approved Sephience™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). The approval includes broad labeling for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive PKU. <Read More> 

Anzupgo® (delgocitinib) Topical Cream - New Drug Approval – July 23, 2025 - LEO Pharma, a global leader in medical dermatology, announced that the U.S. Food and Drug Administration (FDA) has approved Anzupgo® (delgocitinib) cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Anzupgo® is an innovative steroid-free, topical pan-Janus kinase (JAK) inhibitor for adults with CHE. <Read More>

New Label Expansions

Alhemo® (concizumab-mtci) Injection – New Label Expansion – July 31, 2025 – The U.S. Food and Drug Administration has approved Alhemo® (concizumab-mtci) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. Alhemo® is injected subcutaneously (under the skin) daily. <Read More> 

Leqvio® (inclisiran) Injection - New Label Expansion – July 31, 2025 - Novartis announced that the US Food and Drug Administration (FDA) has approved a label update for Leqvio® (inclisiran), enabling its use as monotherapy along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. The FDA proactively requested the label update based on the robust LDL-C lowering data for PCSK9-targeting therapies. <Read More>

Biktarvy® (bictegravir, emtricitabine and tenofovir alafenamide) Tablets - New Label Expansion – July 30, 2025 - Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has granted a new approval for a novel indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF). This new indication expands Biktarvy®’s label to include the treatment of people with HIV (PWH) with an antiretroviral treatment (ART) history who are not virologically suppressed, with no known or suspected resistance to the integrase strand inhibitor (INSTI) class, emtricitabine or tenofovir. <Read More> 

Empaveli® (pegcetacoplan) Injection - New Label Expansion – July 28, 2025 - Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced that the U.S. Food and Drug Administration (FDA) has approved Empaveli® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. C3G and primary IC-MPGN are rare kidney diseases, affecting 5,000 people in the United States. <Read More>

Skytrofa® (lonapegsomatropin-tcgd) Lyophilized Powder for Injection – New Label Expansion – July 28, 2025 - Ascendis Pharma A/S (Nasdaq: ASND) announced that the U.S. Food & Drug Administration (FDA) has approved Skytrofa® (lonapegsomatropin-tcgd; developed as TransCon hGH) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD), a rare disorder resulting from decreased or total loss of growth hormone production. Lonapegsomatropin (approved by the FDA in 2021 for the treatment of pediatric GHD) is a prodrug of somatropin (human growth hormone, or hGH) administered once weekly, providing sustained release of active, unmodified somatropin. <Read More> 

Doptelet® (avatrombopag) Tablets and Oral Granules - New Label Expansion – July 25, 2025 - Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), announced that the U.S. Food and Drug Administration (FDA) approved Doptelet® (avatrombopag) for the treatment of thrombocytopenia in pediatric patients one year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a prior therapy.  The approval also includes a new formulation, Doptelet® Sprinkle (avatrombopag) oral granules, for use in children ages one to less than six years. <Read More>

Shingrix® (zoster vaccine recombinant, adjuvanted) Injection - New Label Expansion – July 17, 2025 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved a prefilled syringe presentation of Shingrix® (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster). The new prefilled syringe removes the need to reconstitute separate vials prior to administration, simplifying the vaccine administration process for healthcare professionals. <Read More> 

Kerendia® (finerenone) Tablets - New Label Expansion – July 14, 2025 - Bayer announced that the U.S. Food and Drug Administration (FDA) approved Kerendia® (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, following the agency’s Priority Review of its supplemental New Drug Application (sNDA). <Read More>

Spikevax® (Moderna COVID-19 Vaccine) (COVID-19 Vaccine, mRNA) Injection - New Label Expansion – July 10, 2025 - Moderna, Inc. (NASDAQ:MRNA) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax®, the Company's COVID-19 vaccine, in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. The Company's COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under Emergency Use Authorization (EUA). <Read More> 

Kisunla™ (donanemab-azbt) Injection - New Label Expansion – July 9, 2025 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla™ (donanemab-azbt), Lilly's once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people in the mild dementia stage of AD, with confirmed amyloid pathology. In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) versus the original dosing schedule at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction. <Read More>

New Drug Shortage

August 4, 2025

August 1, 2025

July 29, 2025

July 28, 2025

July 24, 2025

July 23, 2025

July 21, 2025

July 17, 2025

Updated Drug Shortage

August 4, 2025

August 1, 2025

July 31, 2025

July 28, 2025

July 25, 2025

July 24, 2025

July 23, 2025

July 22, 2025

July 18, 2025

July 17, 2025

New Drug Recall and Safety Alerts

Sucralfate Tablets USP 1 Gram by Nostrum Laboratories, Inc. – New Voluntary Recall – July 14, 2025 – Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfate Tablets USP 1 gram, all lots within expiry, as a result of the closures and discontinuation of its Quality activities. This recall pertains only to Sucralfate Tablets USP 1 gram, all lots with expiry, manufactured by Nostrum Labs after June 2023. <Read More> 

New Generic/Biosimilar Approval and Launch

Kirsty™ (insulin aspart-xjhz) Injection - New NovoLog® Biosimilar Approval – July 15, 2025 - Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Kirsty™ (Insulin Aspart-xjhz), 100 units/mL as the first and only interchangeable biosimilar to NovoLog® (Insulin Aspart). Kirsty™ is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Kirsty™ will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use. <Read More>

Clinical and Pharmacy News

PBM Markets are at Risk of Harming Patients – July 31, 2025 – The American Medical Association (AMA) published a new annual analysis (PDF) measuring competition in pharmacy benefit manager (PBM) markets and vertical integration of insurers with PBMs. The assessment demonstrates low competition in PBM markets across the nation and high vertical integration as the largest PBMs share ownership with health insurers. The AMA analysis adds to growing concern over anticompetitive harm resulting from low competition and high vertical integration in the PBM industry. It comes on the heels of reports by the Federal Trade Commission and U.S. House Committee on Oversight and Accountability finding that a handful of PBMs have vast power and control over medication access and affordability. <Read More> 

First Guideline on Alzheimer’s Blood-Based Biomarker Tests Released – July 31, 2025 – An expert panel convened by the Alzheimer’s Association has released the first clinical guidelines to help clinicians choose the most appropriate blood-based biomarker (BBM) test to aid in the diagnosis of Alzheimer’s disease (AD). The evidence-based guideline recommends that tests with ≥ 90% sensitivity and specificity can serve as a substitute for amyloid PET or cerebrospinal fluid (CSF) biomarker testing. Tests with ≥ 90% sensitivity but only ≥ 75% specificity should be used as a triaging test. In this case, a negative result rules out AD pathology with high probability and a positive result should be confirmed with CSF or PET testing. <Read More>

This Year’s Prescription Drug Bills Aim to Reduce Consumer Costs – July 30, 2025 – More than 800 prescription drug access and affordability proposals were introduced across all 50 states, Washington, D.C., and the territories in this year’s legislative sessions. The more than 130 enacted bills included some familiar policies as well as some new ones. Lawmakers were looking for ways to hold costs down through pharmacy benefit manager (PBM) reform, with more than 40 states considering some 270 PBM-related bills. Several themes emerged, including  Prohibiting spread pricing. States may enter contractual arrangements with PBMs to administer state employee health plan and Medicaid prescription benefits. Spread pricing, which is a traditional PBM business model, is a contractual agreement where an insurer or employer pays a higher amount for a prescription drug than the PBM reimbursement to the pharmacy. The PBM then keeps a portion of the spread. Regulating agencies in several states have raised concerns over the spread PBMs retain. <Read More> 

Drugmaker Novo Nordisk Slashes Wegovy® Sales Forecasts, Blaming Compounding – July 29, 2025 – Novo Nordisk's shares plunged more than 20% Tuesday, after the company cut the forecast for its flagship obesity drug. Before the markets opened, the company announced that sales of its obesity medicine, Wegovy®, are expected to grow no more than 14% this year. That's down from its prediction of up to 21% on May 7. The company blames cheaper alternatives made by compounding pharmacies, which are allowed to make what are essentially copies of drugs when they're in short supply. Wegovy® and Ozempic®, a diabetes drug sometimes prescribed for weight loss, had been on the Food and Drug Administration's drug shortage list, paving the way for a boom in compounded versions. <Read More> 

Delinking Pharmacy Benefit Manager Compensation From Drug List Prices Could Unleash Major Savings – July 24, 2025 – Breaking the link between prescription drug list prices and compensation to middlemen like pharmacy benefit managers (PBMs) could cut a significant portion of the U.S.'s annual drug tab, finds a new analysis from the USC Schaeffer Center for Health Policy & Economics. The work is published in the journal Health Affairs Scholar. PBMs, who negotiate drug benefits on behalf of insurers and employers, are typically paid based on a percentage of a drug's list price before rebates and other discounts are applied. Federal and state policymakers have proposed delinking PBM compensation from list prices in response to evidence that PBMs often steer patients toward higher-priced drugs—even when cheaper alternatives are available—to boost their own profits. <Read More> 

New Biosimilars Metric Confirms Switching Efficacy – July 23, 2025 – Most patients who were switched from adalimumab (Humira®, AbbVie) to an interchangeable biosimilar experienced clinical success, with the vast majority remaining on a biosimilar three months after conversion, according to a study conducted at Brown University Health and presented in a poster (38-M) at the ASHP Pharmacy Futures 2025 meeting. The study used data from the center’s electronic health records and specialty pharmacy from Jan. 1, 2023, to June 1, 2024. The primary objective was to evaluate the rate of reversion to the reference product three months after a payor mandated a switch to a biosimilar. <Read More>

Specialty Pharmacies Can Dispense the Emotional Script to Support Patients – July 23, 2025 – Behind every specialty medication is a person facing uncertainty. As this market surges toward unprecedented growth over the next decade, specialty pharmacies are increasingly turning to automation to meet demand and manage costs. However, while efficiency metrics climb, something essential gets lost—the human experience. Specialty pharmacies that prioritize efficiency over empathy risk missing what matters most: meaningful connection during a critical moment in care. Research suggests that adherence may be influenced not only by logistical or clinical barriers but also by emotional and psychological factors, such as fear, uncertainty, and loneliness. <Read More> 

HHS and Private Health Insurers Team Up to Improve Prior Authorization Process – July 14, 2025 - Stakeholders from federal health agencies and leading payors have pledged to streamline the often burdensome prior authorization process that can lead to delays in treatment and poorer clinical outcomes. The new pledge, by America’s Health Insurance Plans (AHIP), a trade organization representing many health insurance companies, was at the center of a recent roundtable discussion that AHIP held with Health and Human Services Secretary Robert F. Kennedy Jr., and Mehmet Oz, MD, the administrator of the  Centers for Medicare & Medicaid Services (CMS). <Read More> 

340B in the News

HHS Announces New 340B Rebate Model Pilot Program – July 31, 2025 – The Department of Health and Human Services issued a notice announcing a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all 340B-covered entities. The notice said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, is inviting certain drug manufacturers to apply for participation in the pilot program for a minimum of one year. HRSA said the pilot program will be limited to the NDC-11s included on the Centers for Medicare & Medicaid Services’ Medicare Drug Price Negotiation Selected Drug List regardless of payer. HRSA said manufacturers must submit applications to participate in the pilot program by Sept. 15, and approvals will be made by Oct. 15 for a Jan. 1, 2026, effective date. <Read More> 


Read More

Clinical Insights: August 6th, 2025

New Drug/Vaccine Approval

Vizz™ (aceclidine) Ophthalmic Solution - formerly LNZ100 – New Drug Approval – July 31, 2025 – LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), announced the US Food and Drug Administration (“FDA”) approved Vizz™ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults. Samples are anticipated in the United States as early as October 2025, with commercial product to be broadly available by mid-Q4 2025. Direct-to-eye care professional sales and marketing activities to be initiated immediately. <Read More>

Sephience™ (sepiapterin) Oral Powder – New Drug Approval – July 28, 2025 - PTC Therapeutics, Inc. (NASDAQ: PTCT) announced that the U.S. Food and Drug Administration (FDA) has approved Sephience™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). The approval includes broad labeling for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive PKU. <Read More> 

Anzupgo® (delgocitinib) Topical Cream - New Drug Approval – July 23, 2025 - LEO Pharma, a global leader in medical dermatology, announced that the U.S. Food and Drug Administration (FDA) has approved Anzupgo® (delgocitinib) cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Anzupgo® is an innovative steroid-free, topical pan-Janus kinase (JAK) inhibitor for adults with CHE. <Read More>

New Label Expansions

Alhemo® (concizumab-mtci) Injection – New Label Expansion – July 31, 2025 – The U.S. Food and Drug Administration has approved Alhemo® (concizumab-mtci) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. Alhemo® is injected subcutaneously (under the skin) daily. <Read More> 

Leqvio® (inclisiran) Injection - New Label Expansion – July 31, 2025 - Novartis announced that the US Food and Drug Administration (FDA) has approved a label update for Leqvio® (inclisiran), enabling its use as monotherapy along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. The FDA proactively requested the label update based on the robust LDL-C lowering data for PCSK9-targeting therapies. <Read More>

Biktarvy® (bictegravir, emtricitabine and tenofovir alafenamide) Tablets - New Label Expansion – July 30, 2025 - Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has granted a new approval for a novel indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF). This new indication expands Biktarvy®’s label to include the treatment of people with HIV (PWH) with an antiretroviral treatment (ART) history who are not virologically suppressed, with no known or suspected resistance to the integrase strand inhibitor (INSTI) class, emtricitabine or tenofovir. <Read More> 

Empaveli® (pegcetacoplan) Injection - New Label Expansion – July 28, 2025 - Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced that the U.S. Food and Drug Administration (FDA) has approved Empaveli® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. C3G and primary IC-MPGN are rare kidney diseases, affecting 5,000 people in the United States. <Read More>

Skytrofa® (lonapegsomatropin-tcgd) Lyophilized Powder for Injection – New Label Expansion – July 28, 2025 - Ascendis Pharma A/S (Nasdaq: ASND) announced that the U.S. Food & Drug Administration (FDA) has approved Skytrofa® (lonapegsomatropin-tcgd; developed as TransCon hGH) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD), a rare disorder resulting from decreased or total loss of growth hormone production. Lonapegsomatropin (approved by the FDA in 2021 for the treatment of pediatric GHD) is a prodrug of somatropin (human growth hormone, or hGH) administered once weekly, providing sustained release of active, unmodified somatropin. <Read More> 

Doptelet® (avatrombopag) Tablets and Oral Granules - New Label Expansion – July 25, 2025 - Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), announced that the U.S. Food and Drug Administration (FDA) approved Doptelet® (avatrombopag) for the treatment of thrombocytopenia in pediatric patients one year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a prior therapy.  The approval also includes a new formulation, Doptelet® Sprinkle (avatrombopag) oral granules, for use in children ages one to less than six years. <Read More>

Shingrix® (zoster vaccine recombinant, adjuvanted) Injection - New Label Expansion – July 17, 2025 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved a prefilled syringe presentation of Shingrix® (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster). The new prefilled syringe removes the need to reconstitute separate vials prior to administration, simplifying the vaccine administration process for healthcare professionals. <Read More> 

Kerendia® (finerenone) Tablets - New Label Expansion – July 14, 2025 - Bayer announced that the U.S. Food and Drug Administration (FDA) approved Kerendia® (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, following the agency’s Priority Review of its supplemental New Drug Application (sNDA). <Read More>

Spikevax® (Moderna COVID-19 Vaccine) (COVID-19 Vaccine, mRNA) Injection - New Label Expansion – July 10, 2025 - Moderna, Inc. (NASDAQ:MRNA) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax®, the Company's COVID-19 vaccine, in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. The Company's COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under Emergency Use Authorization (EUA). <Read More> 

Kisunla™ (donanemab-azbt) Injection - New Label Expansion – July 9, 2025 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla™ (donanemab-azbt), Lilly's once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people in the mild dementia stage of AD, with confirmed amyloid pathology. In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) versus the original dosing schedule at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction. <Read More>

New Drug Shortage

August 4, 2025

August 1, 2025

July 29, 2025

July 28, 2025

July 24, 2025

July 23, 2025

July 21, 2025

July 17, 2025

Updated Drug Shortage

August 4, 2025

August 1, 2025

July 31, 2025

July 28, 2025

July 25, 2025

July 24, 2025

July 23, 2025

July 22, 2025

July 18, 2025

July 17, 2025

New Drug Recall and Safety Alerts

Sucralfate Tablets USP 1 Gram by Nostrum Laboratories, Inc. – New Voluntary Recall – July 14, 2025 – Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfate Tablets USP 1 gram, all lots within expiry, as a result of the closures and discontinuation of its Quality activities. This recall pertains only to Sucralfate Tablets USP 1 gram, all lots with expiry, manufactured by Nostrum Labs after June 2023. <Read More> 

New Generic/Biosimilar Approval and Launch

Kirsty™ (insulin aspart-xjhz) Injection - New NovoLog® Biosimilar Approval – July 15, 2025 - Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Kirsty™ (Insulin Aspart-xjhz), 100 units/mL as the first and only interchangeable biosimilar to NovoLog® (Insulin Aspart). Kirsty™ is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Kirsty™ will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use. <Read More>

Clinical and Pharmacy News

PBM Markets are at Risk of Harming Patients – July 31, 2025 – The American Medical Association (AMA) published a new annual analysis (PDF) measuring competition in pharmacy benefit manager (PBM) markets and vertical integration of insurers with PBMs. The assessment demonstrates low competition in PBM markets across the nation and high vertical integration as the largest PBMs share ownership with health insurers. The AMA analysis adds to growing concern over anticompetitive harm resulting from low competition and high vertical integration in the PBM industry. It comes on the heels of reports by the Federal Trade Commission and U.S. House Committee on Oversight and Accountability finding that a handful of PBMs have vast power and control over medication access and affordability. <Read More> 

First Guideline on Alzheimer’s Blood-Based Biomarker Tests Released – July 31, 2025 – An expert panel convened by the Alzheimer’s Association has released the first clinical guidelines to help clinicians choose the most appropriate blood-based biomarker (BBM) test to aid in the diagnosis of Alzheimer’s disease (AD). The evidence-based guideline recommends that tests with ≥ 90% sensitivity and specificity can serve as a substitute for amyloid PET or cerebrospinal fluid (CSF) biomarker testing. Tests with ≥ 90% sensitivity but only ≥ 75% specificity should be used as a triaging test. In this case, a negative result rules out AD pathology with high probability and a positive result should be confirmed with CSF or PET testing. <Read More>

This Year’s Prescription Drug Bills Aim to Reduce Consumer Costs – July 30, 2025 – More than 800 prescription drug access and affordability proposals were introduced across all 50 states, Washington, D.C., and the territories in this year’s legislative sessions. The more than 130 enacted bills included some familiar policies as well as some new ones. Lawmakers were looking for ways to hold costs down through pharmacy benefit manager (PBM) reform, with more than 40 states considering some 270 PBM-related bills. Several themes emerged, including  Prohibiting spread pricing. States may enter contractual arrangements with PBMs to administer state employee health plan and Medicaid prescription benefits. Spread pricing, which is a traditional PBM business model, is a contractual agreement where an insurer or employer pays a higher amount for a prescription drug than the PBM reimbursement to the pharmacy. The PBM then keeps a portion of the spread. Regulating agencies in several states have raised concerns over the spread PBMs retain. <Read More> 

Drugmaker Novo Nordisk Slashes Wegovy® Sales Forecasts, Blaming Compounding – July 29, 2025 – Novo Nordisk's shares plunged more than 20% Tuesday, after the company cut the forecast for its flagship obesity drug. Before the markets opened, the company announced that sales of its obesity medicine, Wegovy®, are expected to grow no more than 14% this year. That's down from its prediction of up to 21% on May 7. The company blames cheaper alternatives made by compounding pharmacies, which are allowed to make what are essentially copies of drugs when they're in short supply. Wegovy® and Ozempic®, a diabetes drug sometimes prescribed for weight loss, had been on the Food and Drug Administration's drug shortage list, paving the way for a boom in compounded versions. <Read More> 

Delinking Pharmacy Benefit Manager Compensation From Drug List Prices Could Unleash Major Savings – July 24, 2025 – Breaking the link between prescription drug list prices and compensation to middlemen like pharmacy benefit managers (PBMs) could cut a significant portion of the U.S.'s annual drug tab, finds a new analysis from the USC Schaeffer Center for Health Policy & Economics. The work is published in the journal Health Affairs Scholar. PBMs, who negotiate drug benefits on behalf of insurers and employers, are typically paid based on a percentage of a drug's list price before rebates and other discounts are applied. Federal and state policymakers have proposed delinking PBM compensation from list prices in response to evidence that PBMs often steer patients toward higher-priced drugs—even when cheaper alternatives are available—to boost their own profits. <Read More> 

New Biosimilars Metric Confirms Switching Efficacy – July 23, 2025 – Most patients who were switched from adalimumab (Humira®, AbbVie) to an interchangeable biosimilar experienced clinical success, with the vast majority remaining on a biosimilar three months after conversion, according to a study conducted at Brown University Health and presented in a poster (38-M) at the ASHP Pharmacy Futures 2025 meeting. The study used data from the center’s electronic health records and specialty pharmacy from Jan. 1, 2023, to June 1, 2024. The primary objective was to evaluate the rate of reversion to the reference product three months after a payor mandated a switch to a biosimilar. <Read More>

Specialty Pharmacies Can Dispense the Emotional Script to Support Patients – July 23, 2025 – Behind every specialty medication is a person facing uncertainty. As this market surges toward unprecedented growth over the next decade, specialty pharmacies are increasingly turning to automation to meet demand and manage costs. However, while efficiency metrics climb, something essential gets lost—the human experience. Specialty pharmacies that prioritize efficiency over empathy risk missing what matters most: meaningful connection during a critical moment in care. Research suggests that adherence may be influenced not only by logistical or clinical barriers but also by emotional and psychological factors, such as fear, uncertainty, and loneliness. <Read More> 

HHS and Private Health Insurers Team Up to Improve Prior Authorization Process – July 14, 2025 - Stakeholders from federal health agencies and leading payors have pledged to streamline the often burdensome prior authorization process that can lead to delays in treatment and poorer clinical outcomes. The new pledge, by America’s Health Insurance Plans (AHIP), a trade organization representing many health insurance companies, was at the center of a recent roundtable discussion that AHIP held with Health and Human Services Secretary Robert F. Kennedy Jr., and Mehmet Oz, MD, the administrator of the  Centers for Medicare & Medicaid Services (CMS). <Read More> 

340B in the News

HHS Announces New 340B Rebate Model Pilot Program – July 31, 2025 – The Department of Health and Human Services issued a notice announcing a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all 340B-covered entities. The notice said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, is inviting certain drug manufacturers to apply for participation in the pilot program for a minimum of one year. HRSA said the pilot program will be limited to the NDC-11s included on the Centers for Medicare & Medicaid Services’ Medicare Drug Price Negotiation Selected Drug List regardless of payer. HRSA said manufacturers must submit applications to participate in the pilot program by Sept. 15, and approvals will be made by Oct. 15 for a Jan. 1, 2026, effective date. <Read More> 


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Ready to get started?

The Pillr Health team is here to empower your 340B program, and beyond. Reach out at the link below.

Contact Us