Clinical Insights: March 20, 2024

Clinical Insights: April 17, 2024

Clinical Insights: April 3, 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

Voydeya™ (danicopan) Tablets – New Drug Approval – March 29, 2024 – Voydeya™ (danicopan) has been approved in the US as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular haemolysis (EVH) in adults with paroxysmal nocturnal haemoglobinuria (PNH). Voydeya™ is a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-care Ultomiris® (ravulizumab) or Soliris® (eculizumab) to address the needs of the approximately 10-20% of patients with PNH who experience clinically significant EVH while treated with a C5 inhibitor. <Read More>  Vafseo® (vadadustat) Tablets – New Drug Approval – March 27, 2024 – Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo® (vadadustat) Tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo® is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. Vafseo® is now approved in 37 countries. <Read More> Winrevair™ (sotatercept) for Injection – New Orphan Drug Approval – March 26, 2024 – Merck (NYSE: MRK) announced that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name: Winrevair™, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. Winrevair™ was previously granted Breakthrough Therapy Designation by the FDA. Winrevair™ is the first FDA-approved activin signaling inhibitor therapy for PAH, representing a new class of therapy that works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH. <Read More> Opsynvi® (macitentan and tadalafil) Tablets – New Orphan Drug Approval – March 22, 2024 – Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III. Opsynvi® may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. Opsynvi® may be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets. <Read More> Duvyzat™ (givinostat) Oral Suspension – New Orphan Drug Approval – March 21, 2024 – The U.S. Food and Drug Administration approved Duvyzat™ (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat™ is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle. <Read More> Tryvio™ (aprocitentan) Tablets – New Drug Approval – March 20, 2024 – Idorsia Ltd (SIX: IDIA) announced that the US Food and Drug Administration (FDA) has approved Tryvio™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The recommended dosage of Tryvio™ is 12.5 mg orally once daily, with or without food. <Read More>

New Indication/Dosage/Formulation Approval

Vemlidy® (tenofovir alafenamide) Tablets – New Label Expansion – March 27, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy® (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease. <Read More> Elahere® (mirvetuximab soravtansine-gynx) Injection – New Label Expansion – March 22, 2024 – AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Elahere® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. Patients with these cancers often present with late-stage disease, undergo surgery and are then treated with platinum-based chemotherapy. They may become resistant to this treatment and require another therapy, such as Elahere®. <Read More> Nexletol® (bempedoic acid) and Nexlizet® (bempedoic acid and ezetimibe) Tablets – New Label Expansion – March 22, 2024 – Esperion (NASDAQ: ESPR) announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for Nexletol® (bempedoic acid) Tablets and Nexlizet® (bempedoic acid and ezetimibe) Tablets based on positive CLEAR Outcomes data that include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients. In addition, the enhanced labels support the use of Nexletol® and Nexlizet® either alone or in combination with statins. They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients. <Read More>  Ultomiris® (ravulizumab-cwvz) Injection – New Label Expansion – March 22, 2024 – Ultomiris® (ravulizumab-cwvz) has been approved in the United States (US) as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). The approval by the US Food and Drug Administration (FDA) was based on positive results from the CHAMPION-NMOSD Phase III trial, which were published in the Annals of Neurology. In the trial, Ultomiris® was compared to an external placebo arm from the pivotal Soliris PREVENT clinical trial. <Read More> Ixinity® (coagulation factor IX (recombinant)) for Injection – New label Expansion – March 22, 2024 – Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) announced that the US Food and Drug Administration (FDA) recently approved Medexus's supplemental Biologics License Application (sBLA) for Ixinity® [coagulation factor IX (recombinant)] for the on-demand, prophylactic, and perioperative treatment of pediatric patients under 12 years of age with hemophilia B. Ixinity®, an intravenous recombinant factor IX therapeutic, is now approved for use in all patients with hemophilia B, a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood. <Read More> Iclusig® (ponatinib) Tablets – New Label Expansion – March 19, 2024 – Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Iclusig® (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This accelerated approval application was granted Priority Review and evaluated under the Real-Time Oncology Review (RTOR) program, an FDA initiative designed to expedite the delivery of cancer medicines by allowing components of an application to be reviewed before submission of the complete application. <Read More> Spevigo® (spesolimab-sbzo) Injection – New Label Expansion – March 18, 2024 – Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has approved Spevigo® (spesolimab-sbzo) injection for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients aged 12 and above weighing ≥40 kg. This approval follows the Chinese National Medical Products Administration’s (NMPA) recent approval of Spevigo® for the reduction of occurrence of generalized pustular psoriasis (GPP) in adolescents from 12 years of age with a body weight ≥40 kg and adults. Spevigo® is a novel, humanized selective IgG1 antibody that binds to interleukin-36 receptor (IL-36R), a key part of a signaling pathway within the immune system shown to be involved in the cause of GPP. <Read More>

New Drug Shortage

March 28, 2024

March 27, 2024 

March 26, 2024

March 25, 2024

March 22, 2024

Updated Drug Shortage

April 02, 2024

April 01, 2024

March 29, 2024

March 28, 2024

March 25, 2024

New Drug Recall and Safety Alerts

Atovaquone Oral Suspension, USP 750 mg/5 mL by AvKARE, LLC. – New Voluntary Recall – April 1, 2024 - AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab. <Read More> Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) by Eugia US LLC (f/k/a AuroMedics Pharma LLC) – New Voluntary Recall – March 28, 2024 – Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level due to a customer product complaint for the presence of white particles floating inside of the vial. <Read More> Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL by Amneal Pharmaceuticals, LLC. – New Voluntary Recall – March 27, 2024 – Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can result in an over potent dosing regimen. The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Biden-Harris Administration Furthers Medicare Drug Price Negotiations, Releases New Data on How the President’s Historic Law Lowers Health Care Costs for Women – April 2, 2024 – The Inflation Reduction Act’s Medicare drug price negotiations and other provisions will lower the cost of prescription drugs for millions of women. The U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) released new research showing how key Inflation Reduction Act provisions will lower costs for women enrolled in Medicare, including nearly 30 million women enrolled in Part D. Also, HHS announced that the Centers for Medicare & Medicaid Services (CMS) responded to counteroffers from all manufacturers participating in Medicare drug price negotiations – which the Inflation Reduction Act made possible – and invited them to participate in further discussions. <Read More>  Highly Pathogenic Avian Influenza A (H5N1) Virus Infection Reported in a Person in the U.S. – April 1, 2024 – A person in the United States has tested positive for highly pathogenic avian influenza (HPAI) A(H5N1) virus (“H5N1 bird flu”), as reported by Texas and confirmed by CDC. This person had exposure to dairy cattle in Texas presumed to be infected with HPAI A(H5N1) viruses. The patient reported eye redness (consistent with conjunctivitis), as their only symptom, and is recovering. The patient was told to isolate and is being treated with an antiviral drug for flu. This infection does not change the H5N1 bird flu human health risk assessment for the U.S. general public, which CDC considers to be low. <Read More> Study: ‘Gamechanger’ Diabetes Drugs Cost up to 400 Times More Than Needed – March 28, 2024 – Drug companies are pricing diabetes medicines at almost 400 times the level necessary to make a profit, according to a new study. Researchers said it would also be possible for modern insulin pens, which are safer and offer more accurate doses than vials and syringes, to be used even in low-income countries if pharmaceutical firms “put people before their astronomical profits”. A new generation of diabetes drugs known as GLP-1 receptor agonists (GLP-1s) include Novo Nordisk’s Ozempic® (semaglutide), taken by some celebrities as a weight-loss aid, and Eli Lilly’s Trulicity® (dulaglutide). They are now a standard part of treatment in high-income countries, but are unaffordable in many parts of the world despite rising rates of the condition. <Read More> ASCO Updates Guidelines on Vaccines in Patients with Cancer – March 27, 2024 – The American Society of Clinical Oncology (ASCO) recently issued a new clinical practice guideline, “Vaccinations of Adults with Cancer,” updating its recommendations for patients with cancer of which vaccines to receive. For adult patients of all ages, the guideline recommends: 1) Influenza vaccine annually, 2) COVID-19 vaccine according to the recommended CDC schedule, 3) Tdap or Td vaccine once, followed by a booster every 10 years, 4) Two doses of recombinant zoster vaccine at least 4 weeks apart, 5) One dose of PCV20 pneumococcal vaccine or 1 dose of PCV15 followed by PPSV23 8 weeks later. <Read More>  The Truth About Compounded GLP-1s That Doctors Need to Know – March 26, 2024 – Meanwhile, the APC statement notes, Novo Nordisk and Eli Lilly have sued compounding companies in several states, questioning, among other things, the purity and potency of some compounded products. There are different designations for compounding pharmacies: 503A and 503B. 503As are state-licensed pharmacies and physicians, and 503B pharmacies are federally regulated outsourcing facilities that are strictly regulated by the FDA. This regulation, established following a 2012 fungal meningitis outbreak linked to a compounding pharmacy, ensures higher-quality control and oversight, especially for medications intended for intravenous or epidural use. These standards exceed those required for subcutaneous injections like GLP-1 analogs. <Read More> FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects – March 26, 2024 – The U.S. Food and Drug Administration is warning consumers not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. The agency issued warning letters to six companies for marketing these products in violation of federal law. Some of these products are labeled to contain ingredients, such as lidocaine, at concentrations that are higher than what is permitted for over-the-counter, topical pain relief products. <Read More>

340B in the News

Last Call for Comments on the Bipartisan Discussion Draft of the SUSTAIN Act: Shaping 340B for the Future. – March 26, 2024 – Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug Pricing Program (the “340B Program” or the “Program”). Specifically, industry stakeholders have until April 1st to submit comments to legislators regarding the Discussion Draft Explanatory Statement and Supplemental RFI (the “RFI”) of the “Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act” (the “Sustain 340B Act”). This bipartisan legislative discussion draft was released by the Senate 340B Working Group (the “Working Group”) earlier this year, to update the 340B Program. <Read More>


Clinical Insights: July 10, 2026

New Drug/Vaccine Approval

Tregzi™ (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq) - formerly Orca-T – New Drug Approval – June 30, 2026 – Orca Bio, a commercial-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, announced the U.S. Food and Drug Administration (FDA) has approved Tregzi™ (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq), clinically known as Orca-T®, a precision-engineered cell therapy for use in matched-donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (GVHD)-free survival (cGFS), in the treatment of adults with hematological malignancies. <Read More>

Lumvoa™ (veligrotug-vvze) Injection – New Drug Approval – June 26, 2026 - Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Lumvoa™ (veligrotug-vvze) for the treatment of thyroid eye disease (TED). TED is a rare, debilitating autoimmune disease characterized by inflammation and tissue remodeling around and behind the eyes that can lead to proptosis, diplopia, pain, and vision impairment. <Read More> 

Utebzi™ (tebipenem pivoxil) Tablets – New Drug Approval – June 17, 2026 - The U.S. Food and Drug Administration (FDA) has approved Utebzi™ (tebipenem pivoxil) tablets for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by several susceptible microorganisms in adults who have limited or no alternative oral treatment options. <Read More> 

Ambelvist® (gadoquatrane) Injection – New Drug Approval – June 12, 2026 – Bayer announced that the U.S. Food and Drug Administration (FDA) approved Ambelvist® (gadoquatrane), a new, intravenous macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) indicated for contrast-enhanced magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS) and non-CNS body regions in adult and pediatric patients, including term neonates. <Read More> 

New Label Expansions

Zoryve® (roflumilast) Cream and Foam – New Label Expansion – Patient Population Altered: June 29, 2026 - Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the indication for Zoryve® (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children down to age 2. <Read More> 

Skyrizi® (risankizumab-rzaa) Injection – New Label Expansion – Patient Population Altered: June 26, 2026 - AbbVie (NYSE: ABBV) announced the U.S. Food and Drug Administration (FDA) has approved Skyrizi® (risankizumab-rzaa) for the treatment of children six years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis. A new 55 mg pre-filled syringe (PFS) has also been approved to support weight-based dosing for patients weighing less than 40 kg, while the currently available 150 mg PFS and Pen are approved for patients weighing 40 kg or greater. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – New Indication Approved: June 25, 2026 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Trodelvy® (sacituzumab govitecan-hziy), Gilead’s Trop-2-directed antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-authorized test. <Read More> 

Ibrance® (palbociclib) Capsules and Tablets – New Label Expansion – New Indication Approved: June 24, 2026 - Pfizer Inc. (NYSE: PFE) announced the U.S. Food and Drug Administration (FDA) approved Ibrance® (palbociclib) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) locally advanced or metastatic breast cancer (MBC) following induction treatment. <Read More> 

Trodelvy® (sacituzumab govitecan-hziy) Injection – New Label Expansion – New Indication Approved: June 24, 2026 - Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has approved Trodelvy® (sacituzumab govitecan-hziy), a first-in-class Trop-2-directed antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). <Read More>

Tryngolza® (olezarsen) Injection – New Label Expansion – New Indication Approved: June 24, 2026 - Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has approved Tryngolza® (olezarsen) as an adjunct to diet to reduce triglycerides (TG) and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500 mg/dL). <Read More> 

Capvaxive (pneumococcal 21-valent conjugate vaccine) Injection – New Label Expansion – Patient Population Altered: June 18, 2026 - 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 an expanded indication for Capvaxive® (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. <Read More> 

Rextovy™ (naloxone hydrochloride) Nasal Spray – New Label Expansion – Labeling Revision Approved: June 16, 2026 - The U.S. Food and Drug Administration (FDA) approved another over-the-counter (OTC) intranasal naloxone product, Rextovy™, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose. Consumers may directly purchase this product without a prescription in places such as pharmacies, convenience stores, and online. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – New Indication Approved: June 12, 2026 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapies, each in combination with Welireg® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the adjuvant treatment of adult patients with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. <Read More> 

Tzield® (teplizumab-mzwv) Injection – New Label Expansion – New Indication Approved: June 12, 2026 - The US Food and Drug Administration (FDA) has granted accelerated approval to Tzield® (teplizumab-mzwv) to delay the decline in endogenous (own) insulin production in children aged eight to 17 years recently diagnosed with stage 3 T1D. Tzield is not effective as a disease-modifying therapy in non-autoimmune dysglycemic conditions. <Read More> 

Truqap™ (capivasertib) Tablets – New Label Expansion – New Indication Approved: June 12, 2026 - AstraZeneca’s Truqap™ (capivasertib) in combination with abiraterone and prednisone has been approved in the US as the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC), as detected by a US Food and Drug Administration (FDA)-authorised test. <Read More> 

Ebglyss® (lebrikizumab-lbkz) injection – New Label Expansion – New Dosage Regimen: June 9, 2026 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) approved a regimen of one maintenance dose every eight weeks of a single injection (250 mg/2 mL) of Ebglyss® (lebrikizumab-lbkz) for subcutaneous use in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis. <Read More> 

New Drug Shortage

July 02, 2026

June 30, 2026

June 29, 2026

June 17, 2026

June 15, 2026

Updated Drug Shortage

July 04, 2026

July 02, 2026

July 01, 2026

June 26, 2026

June 25, 2026

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Ranluspec™ (ranibizumab-hkdz) Intravitreal Injection – New Lucentis® Biosimilar Approval – June 2, 2026 - Global pharma major Lupin Limited (Lupin) announced that the United States Food and Drug Administration (U.S. FDA) has approved its ranibizumab, Ranluspec™ (ranibizumab-hkdz), as an interchangeable biosimilar referencing Lucentis® (Genentech). Ranluspec™ is the only interchangeable biosimilar ranibizumab approved in the United States in both vials and pre-filled syringes (PFS). <Read More> 

Clinical and Pharmacy News

A New Era of Precision Depression Treatment – July 6, 2026 - For millions of people living with depression, finding an effective treatment can feel like a long and uncertain journey. Patients often spend months trying different medications, enduring side effects and persistent symptoms while waiting to discover whether a prescription will help. A new study led by researchers at the University of California, Irvine and Mass General Brigham-affiliated McLean Hospital suggests there may be a better way. <Read More> 

Patient Enrollment Begins in a Scientific Trial to Identify the First Effective Treatments for Bundibugyo Virus Disease – July 2, 2026 - In a major international effort to evaluate potential treatments for Ebola disease due to Bundibugyo virus (BVD), the PARTNERS clinical trial has opened enrollment for patients in the Democratic Republic of the Congo. The PARTNERS (Platform Adaptive Randomised Trial for New and Repurposed Filovirus TreatmentS) trial will assess whether two antiviral therapies – a monoclonal antibody (MBP134) and remdesivir – can improve survival among people diagnosed with BVD. It will also evaluate whether combining the two antivirals provides additional benefits. <Read More> 

ChatGPT Misses the Mark in Complex Cases – July 1, 2026 - The artificial intelligence tool ChatGPT often misses medication-related problems (MRPs) or flags nonexistent issues, suggesting that AI cannot replace professional judgment or structured training in pharmacy education, according to research presented at the ASHP Midyear 2025 Clinical Meeting & Exhibition, in Las Vegas (poster 4-045). <Read More> 

PBM–Pharmacy Collaboration Improves Medicaid Outcomes – July 1, 2026 - A pharmacy benefit manager (PBM)–community pharmacy collaboration focused on expanding access to care for Medicaid members with chronic conditions significantly improved patient outcomes, increasing medication adherence by 6 to 11 percentage points across almost all drug categories after program participation, according to a new report from the Elevance Health Public Policy Institute. Patients engaged in the Community Pharmacy Total Care (CPTC) program, created by PBM CarelonRx (a subsidiary of Elevance Health), also improved their treatment compliance rates across multiple Healthcare Effectiveness Data and Information Set (HEDIS) measures. <Read More> 

New in Clinical Guidance | Postpartum CV Care – July 1, 2026 - A new ACC Expert Consensus Decision Pathway (ECDP) addressing "Optimization of Postpartum Care for Patients With and at Risk for Premature and Long-Term Cardiovascular (CV) Disease" provides recommended strategies for successful postpartum cardiovascular care, which should begin before birth and continue through the first year after delivery. Published in JACC, the ECDP acknowledges the many barriers to care during the postpartum period and emphasizes the importance of following a structured approach for optimized maternal cardiovascular health care that begins immediately after delivery and extends through the first year. <Read More> 

ACC Guidance Explores Antiplatelet Therapies for the Management of ASCVD – June 30, 2026 - Major changes have occurred in recent years when it comes to cutting down on the widespread use of aspirin. In fact, numerous clinical trials looking at potentially shortening the duration of dual antiplatelet therapy (DAPT) following revascularization have prompted the American College of Cardiology (ACC) to develop a new scientific statement on that very topic. The document, "Antiplatelet Therapy in the Management of Atherosclerotic Cardiovascular Disease: 2026 ACC Scientific Statement," provides a detailed overview of current clinical evidence for the use of antiplatelet medications in the primary and secondary prevention and management of atherosclerotic cardiovascular disease (ASCVD). <Read More> 

Naloxone Access Continuously Improves as Gaps Persist in Pharmacy – June 30, 2026 - Following the official approval of OTC naloxone products, availability and out-of-pocket (OOP) patient costs have improved significantly between March 2023 and January 2025, according to a JAPhA study. However, when compared with their retail industry counterparts, independent pharmacies demonstrate a significant need to boost naloxone access and decrease OOP costs for their patient populations. <Read More> 

Grocery Pharmacy Conglomerate to Pay $40 Million for Violating False Claims Act – June 26, 2026 - Federal prosecutors alleged promotional discount programs at Giant, Hannaford, Food Lion, and Stop & Shop were not reflected in “usual and customary” submissions, inflating reimbursement ceilings. Qui tam enforcement remained central, with the relator pharmacist credited for exposing pricing-reporting discrepancies and receiving >$6 million from the federal recovery. Parallel litigation against CVS and Walgreens highlights sector-wide vulnerability around U&C definitions, PBM-driven reimbursement pressure, and compliance risk in high-volume retail dispensing. Strategic responses include transitioning grocery pharmacies into integrated care-and-food “health hubs,” leveraging GLP-1 demand, AI-enabled workflow, and fintech platforms (e.g., RxSense) to improve pricing transparency. <Read More> 

As Manufacturers Catch On to Alternative Funding Programs, More Specialty Patients Routed to Overseas Pharmacies – June 18, 2026 - More drug manufacturers are identifying and rejecting alternative funding program (AFP) applications, pushing commercially insured AFP-enrolled patients toward international pharmacies to obtain their specialty medications, according to new data presented at the ASHP Pharmacy Futures 2026 meeting, in St. Louis. The multisite cohort study, conducted by Vanderbilt Specialty Pharmacy, in Nashville, Tennessee, and previously covered in Specialty Pharmacy Continuum, has been conducted across 12 integrated health-system specialty pharmacies and now spans January 2024 through December 2025 and a larger population of 846 patients, 299 of them enrolled in an AFP and 547 not. <Read More> 

340B in the News

CMS Proposes Increases to Medicare Hospital Outpatient Department Payment Rates, Site-Neutral and 340B Changes – July 2, 2026 - The Centers for Medicare & Medicaid Services July 2 issued a proposed rule that would increase Medicare hospital outpatient prospective payment system rates by a net 2.4% in calendar year 2027 compared to 2026. This includes a proposed 3.2% market basket update, offset by a 0.8 percentage point cut for productivity… CMS also proposes to accelerate 340B recoupment by reducing the outpatient PPS conversion factor further from 0.5% annually to 3% annually, allowing the agency to complete recoupment by CY 2029 instead of CY 2041. AHA said that by proposing to speed up its clawback, the agency “will punish 340B hospitals for CMS’ own error in implementing a policy that a unanimous Supreme Court held to be unlawful. <Read More> 

Lilly Slams Door on 340B Drug Deals as Hospitals Cry Foul – June 25, 2026 - Eli Lilly has cut off access to 340B discount pricing for some hospital pharmacies that did not hand over de-identified in-house claims data by the company’s June 8 deadline, escalating a long-simmering fight over who polices the federal discount program and how. Lilly says it is trying to stop duplicate discounts. Hospital trade groups say the move is unlawful and will squeeze already thin safety-net care. <Read More> 

Cassidy's New Plan to Overhaul 340B: Rebates, Contract Pharmacy Limits and More Changes – June 25, 2026 - After years of investigation, the outgoing chairman of the Senate Health, Education, Labor and Pensions Committee has released his take on new legislation to reform the controversial 340B Drug Pricing Program. Sen. Bill Cassidy, R-Louisiana, unveiled a legislative discussion draft that would stand as the first statutory update to the subsidy program in 15 years if introduced and signed into law. Broadly, it contains a slew of measures that have been vehemently opposed by the hospital industry, such as allowances for drug manufacturers to offer upfront discounts or rebates following the submission of claims data “in order to reduce diversion or duplication of discounts,” as well as regular reporting from participating nonprofits on their 340B revenues, costs and eligibility. <Read More> 


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Clinical Insights: July 10, 2026

New Drug/Vaccine Approval

Tregzi™ (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq) - formerly Orca-T – New Drug Approval – June 30, 2026 – Orca Bio, a commercial-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, announced the U.S. Food and Drug Administration (FDA) has approved Tregzi™ (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq), clinically known as Orca-T®, a precision-engineered cell therapy for use in matched-donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (GVHD)-free survival (cGFS), in the treatment of adults with hematological malignancies. <Read More>

Lumvoa™ (veligrotug-vvze) Injection – New Drug Approval – June 26, 2026 - Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Lumvoa™ (veligrotug-vvze) for the treatment of thyroid eye disease (TED). TED is a rare, debilitating autoimmune disease characterized by inflammation and tissue remodeling around and behind the eyes that can lead to proptosis, diplopia, pain, and vision impairment. <Read More> 

Utebzi™ (tebipenem pivoxil) Tablets – New Drug Approval – June 17, 2026 - The U.S. Food and Drug Administration (FDA) has approved Utebzi™ (tebipenem pivoxil) tablets for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by several susceptible microorganisms in adults who have limited or no alternative oral treatment options. <Read More> 

Ambelvist® (gadoquatrane) Injection – New Drug Approval – June 12, 2026 – Bayer announced that the U.S. Food and Drug Administration (FDA) approved Ambelvist® (gadoquatrane), a new, intravenous macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) indicated for contrast-enhanced magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS) and non-CNS body regions in adult and pediatric patients, including term neonates. <Read More> 

New Label Expansions

Zoryve® (roflumilast) Cream and Foam – New Label Expansion – Patient Population Altered: June 29, 2026 - Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the indication for Zoryve® (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children down to age 2. <Read More> 

Skyrizi® (risankizumab-rzaa) Injection – New Label Expansion – Patient Population Altered: June 26, 2026 - AbbVie (NYSE: ABBV) announced the U.S. Food and Drug Administration (FDA) has approved Skyrizi® (risankizumab-rzaa) for the treatment of children six years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis. A new 55 mg pre-filled syringe (PFS) has also been approved to support weight-based dosing for patients weighing less than 40 kg, while the currently available 150 mg PFS and Pen are approved for patients weighing 40 kg or greater. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – New Indication Approved: June 25, 2026 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Trodelvy® (sacituzumab govitecan-hziy), Gilead’s Trop-2-directed antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-authorized test. <Read More> 

Ibrance® (palbociclib) Capsules and Tablets – New Label Expansion – New Indication Approved: June 24, 2026 - Pfizer Inc. (NYSE: PFE) announced the U.S. Food and Drug Administration (FDA) approved Ibrance® (palbociclib) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) locally advanced or metastatic breast cancer (MBC) following induction treatment. <Read More> 

Trodelvy® (sacituzumab govitecan-hziy) Injection – New Label Expansion – New Indication Approved: June 24, 2026 - Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has approved Trodelvy® (sacituzumab govitecan-hziy), a first-in-class Trop-2-directed antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). <Read More>

Tryngolza® (olezarsen) Injection – New Label Expansion – New Indication Approved: June 24, 2026 - Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has approved Tryngolza® (olezarsen) as an adjunct to diet to reduce triglycerides (TG) and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500 mg/dL). <Read More> 

Capvaxive (pneumococcal 21-valent conjugate vaccine) Injection – New Label Expansion – Patient Population Altered: June 18, 2026 - 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 an expanded indication for Capvaxive® (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. <Read More> 

Rextovy™ (naloxone hydrochloride) Nasal Spray – New Label Expansion – Labeling Revision Approved: June 16, 2026 - The U.S. Food and Drug Administration (FDA) approved another over-the-counter (OTC) intranasal naloxone product, Rextovy™, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose. Consumers may directly purchase this product without a prescription in places such as pharmacies, convenience stores, and online. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – New Indication Approved: June 12, 2026 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapies, each in combination with Welireg® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the adjuvant treatment of adult patients with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. <Read More> 

Tzield® (teplizumab-mzwv) Injection – New Label Expansion – New Indication Approved: June 12, 2026 - The US Food and Drug Administration (FDA) has granted accelerated approval to Tzield® (teplizumab-mzwv) to delay the decline in endogenous (own) insulin production in children aged eight to 17 years recently diagnosed with stage 3 T1D. Tzield is not effective as a disease-modifying therapy in non-autoimmune dysglycemic conditions. <Read More> 

Truqap™ (capivasertib) Tablets – New Label Expansion – New Indication Approved: June 12, 2026 - AstraZeneca’s Truqap™ (capivasertib) in combination with abiraterone and prednisone has been approved in the US as the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC), as detected by a US Food and Drug Administration (FDA)-authorised test. <Read More> 

Ebglyss® (lebrikizumab-lbkz) injection – New Label Expansion – New Dosage Regimen: June 9, 2026 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) approved a regimen of one maintenance dose every eight weeks of a single injection (250 mg/2 mL) of Ebglyss® (lebrikizumab-lbkz) for subcutaneous use in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis. <Read More> 

New Drug Shortage

July 02, 2026

June 30, 2026

June 29, 2026

June 17, 2026

June 15, 2026

Updated Drug Shortage

July 04, 2026

July 02, 2026

July 01, 2026

June 26, 2026

June 25, 2026

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Ranluspec™ (ranibizumab-hkdz) Intravitreal Injection – New Lucentis® Biosimilar Approval – June 2, 2026 - Global pharma major Lupin Limited (Lupin) announced that the United States Food and Drug Administration (U.S. FDA) has approved its ranibizumab, Ranluspec™ (ranibizumab-hkdz), as an interchangeable biosimilar referencing Lucentis® (Genentech). Ranluspec™ is the only interchangeable biosimilar ranibizumab approved in the United States in both vials and pre-filled syringes (PFS). <Read More> 

Clinical and Pharmacy News

A New Era of Precision Depression Treatment – July 6, 2026 - For millions of people living with depression, finding an effective treatment can feel like a long and uncertain journey. Patients often spend months trying different medications, enduring side effects and persistent symptoms while waiting to discover whether a prescription will help. A new study led by researchers at the University of California, Irvine and Mass General Brigham-affiliated McLean Hospital suggests there may be a better way. <Read More> 

Patient Enrollment Begins in a Scientific Trial to Identify the First Effective Treatments for Bundibugyo Virus Disease – July 2, 2026 - In a major international effort to evaluate potential treatments for Ebola disease due to Bundibugyo virus (BVD), the PARTNERS clinical trial has opened enrollment for patients in the Democratic Republic of the Congo. The PARTNERS (Platform Adaptive Randomised Trial for New and Repurposed Filovirus TreatmentS) trial will assess whether two antiviral therapies – a monoclonal antibody (MBP134) and remdesivir – can improve survival among people diagnosed with BVD. It will also evaluate whether combining the two antivirals provides additional benefits. <Read More> 

ChatGPT Misses the Mark in Complex Cases – July 1, 2026 - The artificial intelligence tool ChatGPT often misses medication-related problems (MRPs) or flags nonexistent issues, suggesting that AI cannot replace professional judgment or structured training in pharmacy education, according to research presented at the ASHP Midyear 2025 Clinical Meeting & Exhibition, in Las Vegas (poster 4-045). <Read More> 

PBM–Pharmacy Collaboration Improves Medicaid Outcomes – July 1, 2026 - A pharmacy benefit manager (PBM)–community pharmacy collaboration focused on expanding access to care for Medicaid members with chronic conditions significantly improved patient outcomes, increasing medication adherence by 6 to 11 percentage points across almost all drug categories after program participation, according to a new report from the Elevance Health Public Policy Institute. Patients engaged in the Community Pharmacy Total Care (CPTC) program, created by PBM CarelonRx (a subsidiary of Elevance Health), also improved their treatment compliance rates across multiple Healthcare Effectiveness Data and Information Set (HEDIS) measures. <Read More> 

New in Clinical Guidance | Postpartum CV Care – July 1, 2026 - A new ACC Expert Consensus Decision Pathway (ECDP) addressing "Optimization of Postpartum Care for Patients With and at Risk for Premature and Long-Term Cardiovascular (CV) Disease" provides recommended strategies for successful postpartum cardiovascular care, which should begin before birth and continue through the first year after delivery. Published in JACC, the ECDP acknowledges the many barriers to care during the postpartum period and emphasizes the importance of following a structured approach for optimized maternal cardiovascular health care that begins immediately after delivery and extends through the first year. <Read More> 

ACC Guidance Explores Antiplatelet Therapies for the Management of ASCVD – June 30, 2026 - Major changes have occurred in recent years when it comes to cutting down on the widespread use of aspirin. In fact, numerous clinical trials looking at potentially shortening the duration of dual antiplatelet therapy (DAPT) following revascularization have prompted the American College of Cardiology (ACC) to develop a new scientific statement on that very topic. The document, "Antiplatelet Therapy in the Management of Atherosclerotic Cardiovascular Disease: 2026 ACC Scientific Statement," provides a detailed overview of current clinical evidence for the use of antiplatelet medications in the primary and secondary prevention and management of atherosclerotic cardiovascular disease (ASCVD). <Read More> 

Naloxone Access Continuously Improves as Gaps Persist in Pharmacy – June 30, 2026 - Following the official approval of OTC naloxone products, availability and out-of-pocket (OOP) patient costs have improved significantly between March 2023 and January 2025, according to a JAPhA study. However, when compared with their retail industry counterparts, independent pharmacies demonstrate a significant need to boost naloxone access and decrease OOP costs for their patient populations. <Read More> 

Grocery Pharmacy Conglomerate to Pay $40 Million for Violating False Claims Act – June 26, 2026 - Federal prosecutors alleged promotional discount programs at Giant, Hannaford, Food Lion, and Stop & Shop were not reflected in “usual and customary” submissions, inflating reimbursement ceilings. Qui tam enforcement remained central, with the relator pharmacist credited for exposing pricing-reporting discrepancies and receiving >$6 million from the federal recovery. Parallel litigation against CVS and Walgreens highlights sector-wide vulnerability around U&C definitions, PBM-driven reimbursement pressure, and compliance risk in high-volume retail dispensing. Strategic responses include transitioning grocery pharmacies into integrated care-and-food “health hubs,” leveraging GLP-1 demand, AI-enabled workflow, and fintech platforms (e.g., RxSense) to improve pricing transparency. <Read More> 

As Manufacturers Catch On to Alternative Funding Programs, More Specialty Patients Routed to Overseas Pharmacies – June 18, 2026 - More drug manufacturers are identifying and rejecting alternative funding program (AFP) applications, pushing commercially insured AFP-enrolled patients toward international pharmacies to obtain their specialty medications, according to new data presented at the ASHP Pharmacy Futures 2026 meeting, in St. Louis. The multisite cohort study, conducted by Vanderbilt Specialty Pharmacy, in Nashville, Tennessee, and previously covered in Specialty Pharmacy Continuum, has been conducted across 12 integrated health-system specialty pharmacies and now spans January 2024 through December 2025 and a larger population of 846 patients, 299 of them enrolled in an AFP and 547 not. <Read More> 

340B in the News

CMS Proposes Increases to Medicare Hospital Outpatient Department Payment Rates, Site-Neutral and 340B Changes – July 2, 2026 - The Centers for Medicare & Medicaid Services July 2 issued a proposed rule that would increase Medicare hospital outpatient prospective payment system rates by a net 2.4% in calendar year 2027 compared to 2026. This includes a proposed 3.2% market basket update, offset by a 0.8 percentage point cut for productivity… CMS also proposes to accelerate 340B recoupment by reducing the outpatient PPS conversion factor further from 0.5% annually to 3% annually, allowing the agency to complete recoupment by CY 2029 instead of CY 2041. AHA said that by proposing to speed up its clawback, the agency “will punish 340B hospitals for CMS’ own error in implementing a policy that a unanimous Supreme Court held to be unlawful. <Read More> 

Lilly Slams Door on 340B Drug Deals as Hospitals Cry Foul – June 25, 2026 - Eli Lilly has cut off access to 340B discount pricing for some hospital pharmacies that did not hand over de-identified in-house claims data by the company’s June 8 deadline, escalating a long-simmering fight over who polices the federal discount program and how. Lilly says it is trying to stop duplicate discounts. Hospital trade groups say the move is unlawful and will squeeze already thin safety-net care. <Read More> 

Cassidy's New Plan to Overhaul 340B: Rebates, Contract Pharmacy Limits and More Changes – June 25, 2026 - After years of investigation, the outgoing chairman of the Senate Health, Education, Labor and Pensions Committee has released his take on new legislation to reform the controversial 340B Drug Pricing Program. Sen. Bill Cassidy, R-Louisiana, unveiled a legislative discussion draft that would stand as the first statutory update to the subsidy program in 15 years if introduced and signed into law. Broadly, it contains a slew of measures that have been vehemently opposed by the hospital industry, such as allowances for drug manufacturers to offer upfront discounts or rebates following the submission of claims data “in order to reduce diversion or duplication of discounts,” as well as regular reporting from participating nonprofits on their 340B revenues, costs and eligibility. <Read More> 


Read More

Clinical Insights: June 10th, 2026

New Drug/Vaccine Approval

Xocova® (ensitrelvir) Tablets – New Drug Approval – May 29, 2026 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced that the U.S. Food and Drug Administration (FDA) has approved Xocova® (ensitrelvir), an oral antiviral, for post-exposure prophylaxis (PEP) of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. This approval introduces the first and only oral option to help prevent COVID-19 after exposure in the current therapeutic landscape, addressing a critical gap in prevention. Xocova® is a five-day oral regimen with three tablets taken on day one and one tablet taken on days two through five. The approval occurred ahead of the Prescription Drug User Fee Act (PDUFA) action date of June 16, 2026. <Read More> 

Zaynich™ (cefepime and zidebactam) Powder for Injection – New Drug Approval – May 29, 2026 - Wockhardt announced that the U.S. Food and Drug Administration (FDA) has approved Zaynich™ (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. Zaynich™ previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA. <Read More>

Decnupaz™ (pivekimab sunirine-pvzy) Lyophilized Cake for Injection – New Drug Approval – May 27, 2026 – The Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz™, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). Efficacy was evaluated in CADENZA (NCT03386513), a multicenter, open-label, single-arm clinical trial that included adult patients with treatment-naïve BPDCN (N=33) or relapsed or refractory BPDCN (N=51), without evidence of active central nervous system disease. <Read More> 

Hepcludex® (bulevirtide-gmod) Lyophilized Powder for Injection – New Drug Approval – May 22, 2026 – Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex® (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the United States. <Read More>

Differin® Epiduo® Acne Gel (adapalene and benzoyl peroxide) Topical Gel – New Drug Approval – May 22, 2026 – Galderma (SIX: GALD), the pure-play dermatology category leader, announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) use in ages 12 years and older, marking a significant Prescription-to-OTC transition in acne care. <Read More>  

Baxfendy™ (baxdrostat) Tablets – New Drug Approval – May 15, 2026 – AstraZeneca’s Baxfendy™ (baxdrostat) has been approved in the US as a first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled. <Read More>

Trimbow® (beclomethasone dipropionate, formoterol fumarate and glycopyrrolate) Inhalation Aerosol – New Drug Approval – May 14, 2026 – Chiesi USA, Inc. (key-A-zee), a global biopharmaceutical company, announced that the U.S. Food and Drug Administration has approved Trimbow® (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; or BDP/FF/G; 86 mcg/4.9 mcg/10.6 mcg and 172 mcg/4.9 mcg/10.6 mcg) for the maintenance treatment of asthma in adults. <Read More> 

Beqalzi™ (sonrotoclax) Tablets – New Drug Approval – May 13, 2026 – BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Beqalzi™ (bee-KAHL-zee; sonrotoclax), a foundational, next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. <Read More>

New Label Expansions

Hympavzi® (marstacimab-hncq) Injection – New Label Expansion – Patient Population Altered: June 8, 2026 - Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Hympavzi® (marstacimab-hncq) to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. Hympavzi® is now indicated in the U.S. for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors. <Read More> 

Afrezza® (insulin human [rDNA origin]) Inhalation Powder – New Labl Expansion – Patient Population Altered: May 29, 2026 - MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Afrezza® (insulin human) Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes. <Read More> 

Imfinzi® (durvalumab) Injection – New Label Expansion – New Indication: May 28, 2026 - The Food and Drug Administration approved durvalumab (Imfinzi®, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). <Read More> 

Datroway® (datopotamab deruxtecan-dlnk) Lyophilized Powder for Injection – New Label Expansion – New Indication: May 22, 2026 - AstraZeneca and Daiichi Sankyo’s Datroway® (datopotamab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval follows Priority Review by the Food and Drug Administration (FDA) based on results from the TROPION-Breast02 Phase III trial which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. <Read More> 

Linzess® (linaclotide) Capsules - New Label Expansion – Patient Population Altered: May 21, 2026 - Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life changing therapies for people living with gastrointestinal (GI) and rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the use of Linzess® (linaclotide) in pediatric patients 2 years of age and older with functional constipation (FC). Linzess® was previously approved for pediatric patients 6 years and older with FC. <Read More> 

Tecentriq® (atezolizumab) Injection - New Label Expansion – New Indication: May 15, 2026 - Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) as an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy, as identified by Natera’s Signatera™ CDx personalized MRD assay. <Read More> 

Enhertu® (fam-trastuzumab deruxtecan-nxki) Injection - New Label Expansion – New Indication: May 15, 2026 - AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) has been approved by the US Food and Drug Administration (FDA) for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials, respectively. <Read More> 

Fasenra® (benralizumab) Injection - New Label Expansion – New Indication: May 13, 2026 - AstraZeneca’s Fasenra® (benralizumab) has been approved by the US FDA for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause. The approval by the US Food and Drug Administration (FDA) was based on positive results from the NATRON Phase III trial that evaluated the efficacy and safety of Fasenra® in patients with HES. <Read More> 

Inqovi® (decitabine and cedazuridine) Tablets - New Label Expansion – New Indication: May 13, 2026 - Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved Inqovi® (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or who are ineligible for intensive induction chemotherapy. Inqovi® in combination with venetoclax is the first and only all-oral combination treatment regimen approved for this patient population, offering an alternative to parenteral hypomethylating agent–based regimens that require frequent clinic visits. <Read More>

New Drug Shortage

June 08, 2026

June 05, 2026

June 04, 2026

June 01, 2026

May 27, 2026

May 21, 2026

May 15, 2026

May 14, 2026

Updated Drug Shortage

June 09, 2026

June 08, 2026

June 05, 2026

June 04, 2026

June 03, 2026

June 01, 2026

May 27, 2026

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May 22, 2026

May 21, 2026

New Drug Recall and Safety Alerts

DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL by Sun Pharmaceutical Industries, Inc. (Sun Pharma) – New Voluntary Recall – May 13, 2026 - Sun Pharma is voluntarily recalling within the U.S. to the hospital/user level, one batch of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, Lot # HAG2581B, Expiration 05/2027 (675 vials). The single batch of 675 vials is being recalled due to the detection of glass particles in some vials during production. <Read More> 

New Generic/Biosimilar Approval and Launch

Immgolis™ and Immgolis Intri™ (golimumab-sldi) Injection – New Biosimilars for Simponi® and Simponi Aria® – May 15, 2026 – FDA approved Immgolis™ (golimumab-sldi) as an interchangeable biosimilar biological product to Simponiâ (golimumab) and Immgolis Intri™ (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi Aria® (golimumab). Immgolis™ and Immgolis Intri™ are the first biosimilars approved for Simponi® and Simponi Aria, respectively. Immgolis™ is administered by subcutaneous injection in a single-dose prefilled syringe and Immgolis Intri™ is administered as an intravenous infusion prepared from a single dose vial. <Read More> 

Clinical and Pharmacy News

First-ever Guideline on Cardiovascular-Kidney-Metabolic Syndrome Issued – June 9, 2026 - The first-ever clinical practice guideline on cardiovascular-kidney-metabolic (CKM) syndrome from the American Heart Association and the American College of Cardiology details staging to assess how a person’s kidneys, metabolism and heart are functioning. Higher stages of CKM syndrome are associated with a greater burden of serious health conditions, such as Type 2 diabetes, chronic kidney disease, and a higher risk of cardiovascular disease and mortality. <Read More> 

New GLP-3 Drug Significantly Slashes Both Weight and Blood Sugar Levels in Phase III Trial – June 9, 2026 - Over the past few years, GLP-1 drugs have transformed the treatment landscape for obesity and type 2 diabetes… Now, researchers are exploring whether the next wave of therapies can go even further. A Phase III clinical trial, TRANSCEND-T2D-1, evaluated retatrutide in adults with type 2 diabetes. Unlike GLP-1 drugs, retatrutide belongs to an emerging class known as GLP-3 agonists, which target GIP, GLP-1 and glucagon receptors simultaneously to amplify metabolic benefits. <Read More>

The Hidden Reimbursement Crisis in Medicare’s Drug Price Negotiation Program – June 8, 2026 - Dispensing-fee reality under Part D ($0.00-$7.15; mean approximately $0.65) is misaligned with measured cost of dispensing (approximately $15 retail; approximately $90 specialty), embedding predictable losses into Medicare Transaction Facilitator participation. Pharmacy benefit manager–negotiated fee-setting, with limited Centers for Medicare & Medicaid Services (CMS) specificity, predictably drives below-cost reimbursement and risks accelerating independent pharmacy contraction and reduced beneficiary choice. <Read More> 

First Expert Recommendations for Safe GLP-1 Use in Type 1 Diabetes – June 5, 2026 - Off-label use of medications like Ozempic®, Wegovy®, Mounjaro®, and Zepbound® is becoming increasingly common to address weight management, insulin resistance, and diabetes related complications in type 1 diabetes. New expert recommendations provide a framework for safe use while large trials are ongoing. <Read More> 

A Painful Side Effect of Statins Explained After Decades of Mystery – June 2, 2026 – For millions of people, statins are a daily shield against heart disease. But around 10 percent of those who take statins to lower cholesterol experience a mysterious, painful side effect that causes many to discontinue these potentially life-saving medicines. Scientists have recently found one possible reason why. Research from Columbia University and the University of Rochester in the US revealed a potential culprit: a tiny calcium gate inside muscle cells that statins may force open. <Read More> 

Under the Magnifying Glass: A Wave of Drug Price Transparency – June 1, 2026 - In the span of a single week in late January and early February 2026, 3 federal actions—by Congress, the Department of Labor (DOL), and the Federal Trade Commission (FTC)—brought transparency efforts to the forefront of drug pricing policy. Whereas recent reforms have centered on prices set by pharmaceutical companies, this new wave of provisions shifts the focus to the role of pharmacy benefit managers (PBMs). We examine the drug pricing issues that transparency policies aim to address, how they may accomplish those aims, and what conditions are necessary for their success. <Read More> 

From Close Calls to Safer Systems: Rethinking Near Miss Reporting in Healthcare – May 28, 2026 - After decades of focus on improving patient safety, we have seen meaningful progress in key areas like hospital-acquired infections, pressure ulcers, and falls. However, across all disciplines, clinical and administrative leaders, frontline staff, and key industry stakeholders continue to see preventable harm persist. Around one in ten patients experience harm in their care journey, and more than 50 percent of that harm is preventable. <Read More> 

CVS Caremark Will Cover Lilly’s Weight Loss Drug Zepbound Again After Patient Backlash – May 28, 2026 - CVS Caremark will resume covering the weight loss drug Zepbound this year after it removed it from its list of covered medications last year, drugmaker Eli Lilly said Thursday. CVS Caremark is one of the country’s largest pharmacy benefit managers, deciding which medications millions of people in the U.S. can get through insurance and how much they pay out of pocket. <Read More> 

Millions of Insulin Pods may be Leaking, FDA Warns: Here's how to Check Yours – May 27, 2026 - An estimated 7 million Omnipod insulin pods are under a voluntary Medical Device Correction due to a manufacturing error that can make the pods under-deliver insulin. The alert, issued by Insulet Corporation, Inc. and the FDA on May 26, comes after 24 reports of "serious adverse events" including hospitalization caused by high blood glucose levels due to the under-delivery. No deaths have been reported. <Read More> 

340B in the News

Eli Lilly Moves to Deny 340B Pricing Over Data Requirements; AHA Urges Federal Action – June 2, 2026 - Eli Lilly said June 1 it will deny 340B Drug Pricing Program discounts to providers that do not meet its documentation requirements by next week. In a statement shared with media last night, AHA President and CEO Rick Pollack said, “Eli Lilly will soon take the extraordinary step of denying 340B discounts under its unlawful claims data policy. This decision will undoubtedly harm America’s most vulnerable patients and communities, forcing hospitals to divert resources away from care and towards onerous and expensive administrative burdens. <Read More> 

The 340B Contract Pharmacy Market in 2026: A Maturing Industry Dominated by Big Chains and PBMs – June 2, 2026 – It’s time for Drug Channels Institute’s latest exclusive analysis of the 340B contract pharmacy market, which continues to boom along with the overall program’s expansion. However, our 2026 analysis finds that the contract pharmacy market is now entering a more mature phase characterized by consolidation, slower growth, and increasing dominance by the industry’s largest participants. <Read More> 

Audit Pressure Mounts for 340B Programs as Compliance Platforms Aim to Keep Up – May 27, 2026 - HRSA FY2025 audits showed 49% adverse findings, driven mainly by administrative inaccuracies; incorrect OPAIS records appeared in 75% of adverse audits, underscoring persistent master-data governance gaps. Risk-targeted audits (~90%) elevate exposure from tips, OPAIS anomalies, contract-pharmacy complexity, and prior findings; a 68% re-audit failure rate amplifies the need for durable remediation. <Read More> 


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Clinical Insights: June 10th, 2026

New Drug/Vaccine Approval

Xocova® (ensitrelvir) Tablets – New Drug Approval – May 29, 2026 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced that the U.S. Food and Drug Administration (FDA) has approved Xocova® (ensitrelvir), an oral antiviral, for post-exposure prophylaxis (PEP) of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. This approval introduces the first and only oral option to help prevent COVID-19 after exposure in the current therapeutic landscape, addressing a critical gap in prevention. Xocova® is a five-day oral regimen with three tablets taken on day one and one tablet taken on days two through five. The approval occurred ahead of the Prescription Drug User Fee Act (PDUFA) action date of June 16, 2026. <Read More> 

Zaynich™ (cefepime and zidebactam) Powder for Injection – New Drug Approval – May 29, 2026 - Wockhardt announced that the U.S. Food and Drug Administration (FDA) has approved Zaynich™ (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. Zaynich™ previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA. <Read More>

Decnupaz™ (pivekimab sunirine-pvzy) Lyophilized Cake for Injection – New Drug Approval – May 27, 2026 – The Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz™, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). Efficacy was evaluated in CADENZA (NCT03386513), a multicenter, open-label, single-arm clinical trial that included adult patients with treatment-naïve BPDCN (N=33) or relapsed or refractory BPDCN (N=51), without evidence of active central nervous system disease. <Read More> 

Hepcludex® (bulevirtide-gmod) Lyophilized Powder for Injection – New Drug Approval – May 22, 2026 – Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex® (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the United States. <Read More>

Differin® Epiduo® Acne Gel (adapalene and benzoyl peroxide) Topical Gel – New Drug Approval – May 22, 2026 – Galderma (SIX: GALD), the pure-play dermatology category leader, announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) use in ages 12 years and older, marking a significant Prescription-to-OTC transition in acne care. <Read More>  

Baxfendy™ (baxdrostat) Tablets – New Drug Approval – May 15, 2026 – AstraZeneca’s Baxfendy™ (baxdrostat) has been approved in the US as a first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled. <Read More>

Trimbow® (beclomethasone dipropionate, formoterol fumarate and glycopyrrolate) Inhalation Aerosol – New Drug Approval – May 14, 2026 – Chiesi USA, Inc. (key-A-zee), a global biopharmaceutical company, announced that the U.S. Food and Drug Administration has approved Trimbow® (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; or BDP/FF/G; 86 mcg/4.9 mcg/10.6 mcg and 172 mcg/4.9 mcg/10.6 mcg) for the maintenance treatment of asthma in adults. <Read More> 

Beqalzi™ (sonrotoclax) Tablets – New Drug Approval – May 13, 2026 – BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Beqalzi™ (bee-KAHL-zee; sonrotoclax), a foundational, next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. <Read More>

New Label Expansions

Hympavzi® (marstacimab-hncq) Injection – New Label Expansion – Patient Population Altered: June 8, 2026 - Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Hympavzi® (marstacimab-hncq) to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. Hympavzi® is now indicated in the U.S. for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors. <Read More> 

Afrezza® (insulin human [rDNA origin]) Inhalation Powder – New Labl Expansion – Patient Population Altered: May 29, 2026 - MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Afrezza® (insulin human) Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes. <Read More> 

Imfinzi® (durvalumab) Injection – New Label Expansion – New Indication: May 28, 2026 - The Food and Drug Administration approved durvalumab (Imfinzi®, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). <Read More> 

Datroway® (datopotamab deruxtecan-dlnk) Lyophilized Powder for Injection – New Label Expansion – New Indication: May 22, 2026 - AstraZeneca and Daiichi Sankyo’s Datroway® (datopotamab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval follows Priority Review by the Food and Drug Administration (FDA) based on results from the TROPION-Breast02 Phase III trial which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. <Read More> 

Linzess® (linaclotide) Capsules - New Label Expansion – Patient Population Altered: May 21, 2026 - Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life changing therapies for people living with gastrointestinal (GI) and rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the use of Linzess® (linaclotide) in pediatric patients 2 years of age and older with functional constipation (FC). Linzess® was previously approved for pediatric patients 6 years and older with FC. <Read More> 

Tecentriq® (atezolizumab) Injection - New Label Expansion – New Indication: May 15, 2026 - Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) as an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy, as identified by Natera’s Signatera™ CDx personalized MRD assay. <Read More> 

Enhertu® (fam-trastuzumab deruxtecan-nxki) Injection - New Label Expansion – New Indication: May 15, 2026 - AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) has been approved by the US Food and Drug Administration (FDA) for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials, respectively. <Read More> 

Fasenra® (benralizumab) Injection - New Label Expansion – New Indication: May 13, 2026 - AstraZeneca’s Fasenra® (benralizumab) has been approved by the US FDA for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause. The approval by the US Food and Drug Administration (FDA) was based on positive results from the NATRON Phase III trial that evaluated the efficacy and safety of Fasenra® in patients with HES. <Read More> 

Inqovi® (decitabine and cedazuridine) Tablets - New Label Expansion – New Indication: May 13, 2026 - Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved Inqovi® (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or who are ineligible for intensive induction chemotherapy. Inqovi® in combination with venetoclax is the first and only all-oral combination treatment regimen approved for this patient population, offering an alternative to parenteral hypomethylating agent–based regimens that require frequent clinic visits. <Read More>

New Drug Shortage

June 08, 2026

June 05, 2026

June 04, 2026

June 01, 2026

May 27, 2026

May 21, 2026

May 15, 2026

May 14, 2026

Updated Drug Shortage

June 09, 2026

June 08, 2026

June 05, 2026

June 04, 2026

June 03, 2026

June 01, 2026

May 27, 2026

May 26, 2026

May 22, 2026

May 21, 2026

New Drug Recall and Safety Alerts

DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL by Sun Pharmaceutical Industries, Inc. (Sun Pharma) – New Voluntary Recall – May 13, 2026 - Sun Pharma is voluntarily recalling within the U.S. to the hospital/user level, one batch of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, Lot # HAG2581B, Expiration 05/2027 (675 vials). The single batch of 675 vials is being recalled due to the detection of glass particles in some vials during production. <Read More> 

New Generic/Biosimilar Approval and Launch

Immgolis™ and Immgolis Intri™ (golimumab-sldi) Injection – New Biosimilars for Simponi® and Simponi Aria® – May 15, 2026 – FDA approved Immgolis™ (golimumab-sldi) as an interchangeable biosimilar biological product to Simponiâ (golimumab) and Immgolis Intri™ (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi Aria® (golimumab). Immgolis™ and Immgolis Intri™ are the first biosimilars approved for Simponi® and Simponi Aria, respectively. Immgolis™ is administered by subcutaneous injection in a single-dose prefilled syringe and Immgolis Intri™ is administered as an intravenous infusion prepared from a single dose vial. <Read More> 

Clinical and Pharmacy News

First-ever Guideline on Cardiovascular-Kidney-Metabolic Syndrome Issued – June 9, 2026 - The first-ever clinical practice guideline on cardiovascular-kidney-metabolic (CKM) syndrome from the American Heart Association and the American College of Cardiology details staging to assess how a person’s kidneys, metabolism and heart are functioning. Higher stages of CKM syndrome are associated with a greater burden of serious health conditions, such as Type 2 diabetes, chronic kidney disease, and a higher risk of cardiovascular disease and mortality. <Read More> 

New GLP-3 Drug Significantly Slashes Both Weight and Blood Sugar Levels in Phase III Trial – June 9, 2026 - Over the past few years, GLP-1 drugs have transformed the treatment landscape for obesity and type 2 diabetes… Now, researchers are exploring whether the next wave of therapies can go even further. A Phase III clinical trial, TRANSCEND-T2D-1, evaluated retatrutide in adults with type 2 diabetes. Unlike GLP-1 drugs, retatrutide belongs to an emerging class known as GLP-3 agonists, which target GIP, GLP-1 and glucagon receptors simultaneously to amplify metabolic benefits. <Read More>

The Hidden Reimbursement Crisis in Medicare’s Drug Price Negotiation Program – June 8, 2026 - Dispensing-fee reality under Part D ($0.00-$7.15; mean approximately $0.65) is misaligned with measured cost of dispensing (approximately $15 retail; approximately $90 specialty), embedding predictable losses into Medicare Transaction Facilitator participation. Pharmacy benefit manager–negotiated fee-setting, with limited Centers for Medicare & Medicaid Services (CMS) specificity, predictably drives below-cost reimbursement and risks accelerating independent pharmacy contraction and reduced beneficiary choice. <Read More> 

First Expert Recommendations for Safe GLP-1 Use in Type 1 Diabetes – June 5, 2026 - Off-label use of medications like Ozempic®, Wegovy®, Mounjaro®, and Zepbound® is becoming increasingly common to address weight management, insulin resistance, and diabetes related complications in type 1 diabetes. New expert recommendations provide a framework for safe use while large trials are ongoing. <Read More> 

A Painful Side Effect of Statins Explained After Decades of Mystery – June 2, 2026 – For millions of people, statins are a daily shield against heart disease. But around 10 percent of those who take statins to lower cholesterol experience a mysterious, painful side effect that causes many to discontinue these potentially life-saving medicines. Scientists have recently found one possible reason why. Research from Columbia University and the University of Rochester in the US revealed a potential culprit: a tiny calcium gate inside muscle cells that statins may force open. <Read More> 

Under the Magnifying Glass: A Wave of Drug Price Transparency – June 1, 2026 - In the span of a single week in late January and early February 2026, 3 federal actions—by Congress, the Department of Labor (DOL), and the Federal Trade Commission (FTC)—brought transparency efforts to the forefront of drug pricing policy. Whereas recent reforms have centered on prices set by pharmaceutical companies, this new wave of provisions shifts the focus to the role of pharmacy benefit managers (PBMs). We examine the drug pricing issues that transparency policies aim to address, how they may accomplish those aims, and what conditions are necessary for their success. <Read More> 

From Close Calls to Safer Systems: Rethinking Near Miss Reporting in Healthcare – May 28, 2026 - After decades of focus on improving patient safety, we have seen meaningful progress in key areas like hospital-acquired infections, pressure ulcers, and falls. However, across all disciplines, clinical and administrative leaders, frontline staff, and key industry stakeholders continue to see preventable harm persist. Around one in ten patients experience harm in their care journey, and more than 50 percent of that harm is preventable. <Read More> 

CVS Caremark Will Cover Lilly’s Weight Loss Drug Zepbound Again After Patient Backlash – May 28, 2026 - CVS Caremark will resume covering the weight loss drug Zepbound this year after it removed it from its list of covered medications last year, drugmaker Eli Lilly said Thursday. CVS Caremark is one of the country’s largest pharmacy benefit managers, deciding which medications millions of people in the U.S. can get through insurance and how much they pay out of pocket. <Read More> 

Millions of Insulin Pods may be Leaking, FDA Warns: Here's how to Check Yours – May 27, 2026 - An estimated 7 million Omnipod insulin pods are under a voluntary Medical Device Correction due to a manufacturing error that can make the pods under-deliver insulin. The alert, issued by Insulet Corporation, Inc. and the FDA on May 26, comes after 24 reports of "serious adverse events" including hospitalization caused by high blood glucose levels due to the under-delivery. No deaths have been reported. <Read More> 

340B in the News

Eli Lilly Moves to Deny 340B Pricing Over Data Requirements; AHA Urges Federal Action – June 2, 2026 - Eli Lilly said June 1 it will deny 340B Drug Pricing Program discounts to providers that do not meet its documentation requirements by next week. In a statement shared with media last night, AHA President and CEO Rick Pollack said, “Eli Lilly will soon take the extraordinary step of denying 340B discounts under its unlawful claims data policy. This decision will undoubtedly harm America’s most vulnerable patients and communities, forcing hospitals to divert resources away from care and towards onerous and expensive administrative burdens. <Read More> 

The 340B Contract Pharmacy Market in 2026: A Maturing Industry Dominated by Big Chains and PBMs – June 2, 2026 – It’s time for Drug Channels Institute’s latest exclusive analysis of the 340B contract pharmacy market, which continues to boom along with the overall program’s expansion. However, our 2026 analysis finds that the contract pharmacy market is now entering a more mature phase characterized by consolidation, slower growth, and increasing dominance by the industry’s largest participants. <Read More> 

Audit Pressure Mounts for 340B Programs as Compliance Platforms Aim to Keep Up – May 27, 2026 - HRSA FY2025 audits showed 49% adverse findings, driven mainly by administrative inaccuracies; incorrect OPAIS records appeared in 75% of adverse audits, underscoring persistent master-data governance gaps. Risk-targeted audits (~90%) elevate exposure from tips, OPAIS anomalies, contract-pharmacy complexity, and prior findings; a 68% re-audit failure rate amplifies the need for durable remediation. <Read More> 


Read More

Clinical Insights: May 15th, 2026

New Drug/Vaccine Approval

Veppanu™ (vepdegestrant) Tablets – New Drug Approval – May 1, 2026 - Arvinas, Inc. (Nasdaq: ARVN), with its partner Pfizer Inc. (NYSE: PFE), announced that the U.S. Food and Drug Administration (FDA) has granted approval for Veppanu™ (vepdegestrant) for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. This approval marks the first time the FDA has approved a PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader therapy. <Read More>

Otarmeni™ (lunsotogene parvec-cwha) Suspension for Intracochlear Infusion – New Drug Approval – April 23, 2026 - The U.S. Food and Drug Administration approved Otarmeni™ (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy. Otarmeni™ is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene. <Read More> 

Idvynso™ (doravirine and islatravir) Tablets – New Drug Approval – April 20, 2026 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) approved Idvynso™, a new, two-drug single-tablet regimen of 100 mg doravirine and 0.25 mg islatravir, for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine. <Read More> 

New Label Expansions

Ocrevus® (ocrelizumab) Injection – New Label Expansion – Patient Population Altered: May 8, 2026 – Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), has received U.S. Food and Drug Administration (FDA) approval of Ocrevus® (ocrelizumab) intravenous (IV) infusion for the treatment of relapsing-remitting multiple sclerosis (RRMS) in pediatric patients 10 years of age and older who weigh 55 pounds (25 kg) or more. <Read More> 

Vyvgart® (efgartigimod alfa-fcab) Injection – New Label Expansion – New Indication Approved: May 8, 2026 - argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced the U.S. Food and Drug Administration (FDA) approved a label expansion for Vyvgart® (efgartigimod alfa-fcab) and Vyvgart Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG). <Read More> 

Bizengri® (zenocutuzumab-zbco) Injection – New Label Expansion – New Indication Approved: May 8, 2026 – Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has awarded a Commissioner’s National Priority Voucher (CNPV) pilot program voucher for Bizengri® (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. <Read More> 

Jakafi™ (ruxolitinib) Tablets - New Label Expansion – New Dosage Form Approved: May 1, 2026 - Incyte (Nasdaq:INCY) announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis (MF); adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy. <Read More> 

Asceniv™ (immune globulin intravenous, human – slra) Injection - New Label Expansion – Patient Population Altered: April 30, 2026 – ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, announced the U.S. Food and Drug Administration (“FDA”) has approved the Company’s supplemental Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act for Asceniv™. <Read More> 

Auvelity® (dextromethorphan and bupropion) Extended-Release Tablets – New Label Expansion – New Indication Approved: April 30, 2026 – The U.S. Food and Drug Administration approved an expanded use for Auvelity® (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults. The drug is the first FDA-approved treatment for this condition that is not an antipsychotic. FDA initially approved Auvelity® in 2022 to treat major depressive disorder in adults. <Read More> 

Breztri Aerosphere® (budesonide/glycopyrrolate/formoterol fumarate) Inhalation Aerosol – New Label Expansion – Patient Population Altered: April 27, 2026 – AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere® (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) has been approved in the US for the maintenance treatment of asthma in adult and paediatric patients 12 years of age and older. Breztri® is a single-inhaler that combines the efficacy of corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines with a long-acting muscarinic antagonist (LAMA). <Read More> 

Caplyta® (lumateperone) Capsules – New Label Expansion – Labeling Revision Approved: April 24, 2026 - Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on long-term data evaluating the safety and efficacy of Caplyta® (lumateperone) for the prevention of relapse in schizophrenia. <Read More> 

Saphnelo® (anifrolumab-fnia) Injection – New Label Expansion – New Dosage Form Approved: April 24, 2026 – AstraZeneca’s Saphnelo® (anifrolumab) has been approved in the US for self-administration as a once-weekly autoinjector, the Saphnelo® Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top of standard therapy. The approval by the US Food and Drug Administration (FDA) was based on results from the Phase III TULIP-SC trial, which showed that subcutaneous (SC) administration of Saphneloâ led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe SLE while receiving standard therapy. <Read More>

Dupixent® (dupilumab) Injection – New Label Expansion – Patient Population Altered: April 22, 2026 – The US Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of children aged two to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamine (H1AH) treatment. This expands the previous approval for Dupixent® in adults and adolescents aged 12 years and older with CSU. <Read More> 

Tzield® (teplizumab-mzwv) Injection – New Label Expansion – New Indication Approved: April 20, 2026 – The US Food and Drug Administration (FDA) has approved the supplemental biologic license application for Tzield® (teplizumab-mzwv), expanding the indication from eight years and older to as young as one year of age to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D. <Read More> 

Stelara® (ustekinumab) Injection – New Label Expansion – Patient Population Altered: April 15, 2026 – the U.S. Food and Drug Administration (FDA) approved Stelara® (ustekinumab) for the treatment of patients two years and older with moderately to severely active Crohn’s disease (CD). <Read More> 

Filspari® (sparsentan) Tablets – New Label Expansion – New Indication Approved: April 13, 2026 – Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that the U.S. Food and Drug Administration (FDA) has approved Filspari® (sparsentan) to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. Filspari® is the first and only medicine approved by the FDA for the treatment of FSGS, marking its expansion beyond IgA nephropathy (IgAN) into a second rare kidney disease. <Read More> 

Vabysmo® (faricimab-svoa) Intravitreal Injection – New Label Expansion – Labeling Revision Approved: April 9, 2026 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has received U.S. Food and Drug Administration (FDA) approval of Vabysmo® (faricimab-svoa) for the treatment of macular edema due to retinal vein occlusion (RVO) beyond six months. RVO affects over a million Americans and often involves long-term intravitreal therapy to address the chronic nature of the disease. <Read More> 

New Drug Shortage

May 08, 2026

May 07, 2026

May 06, 2026

May 05, 2026

April 29, 2026

Updated Drug Shortage

May 08, 2026

May 07, 2026

May 05, 2026

May 01, 2026

April 30, 2026

New Drug Recall and Safety Alerts

Lactated Ringer’s Injection, 1L, E7500 by B. Braun Medical, Inc. – New Voluntary Recall – April 28, 2026 - B. Braun Medical Inc. is voluntarily recalling two lots of Lactated Ringer’s Injection, E7500, 1L, to the hospital/healthcare facility level. The product has been found to have particulate matter in solution. <Read More> 

New Generic/Biosimilar Approval and Launch

Langlara™ (insulin glargine-aldy) Injection – New Lantus® Biosimilar Approval – April 29, 2026 - Lannett Company, Inc., Lanexa Biologics, a wholly owned subsidiary of Lannett, and Sunshine Lake Pharma announced that the U.S. Food and Drug Administration (FDA) has approved Langlara™ (insulin glargine-aldy), as a biosimilar to Lantus® (insulin glargine), for the treatment of adults and pediatric patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. The FDA has determined that Langlara™ is interchangeable with the reference drug, enabling pharmacists to substitute Langlara™ for Lantus® without prescriber intervention in states that permit such substitution. <Read More> 

Clinical and Pharmacy News

Nearly 3,000 Peer-Reviewed Medical Papers Have Fake Citations, a Columbia Nursing AI-Assisted Audit Finds – May 7, 2026 - A new Columbia University School of Nursing AI-assisted audit reveals nearly 3,000 peer-reviewed medical papers have fake citations that do not exist in scientific databases. The results highlight an alarming trend in academic publishing as the use of AI grows. <Read More> 

Pulmonary Embolism Care Gets Major Update – May 2, 2026 - A new clinical practice guideline has outlined a comprehensive, evidence-based framework for evaluating and managing acute pulmonary embolism in adults. The guideline applies to patients aged 18 years and older and spans the full clinical course, from symptom onset through post-acute follow-up. <Read More> 

Americans’ Challenges With Health Care Costs – April 30, 2026 - For many years, KFF polling has found that the high cost of health care is a burden on U.S. families, and that health care costs factor into decisions about insurance coverage and care seeking. These costs also rank as the top financial worry for adults and their families. This data note summarizes recent KFF polling on the public’s experiences with health care costs. <Read More> 

Prescription Drug Affordability: Examining Select Price Drivers – April 27, 2026 - Prescription drug prices heavily influence the public’s perception of health care affordability. A range of market, regulatory, and structural factors shape the timing and strength of competition in prescription drug markets, including the entry and uptake of generics and biosimilars. Even modest delays contribute to higher spending and slower realization of savings for consumers and taxpayers. This brief examines several drivers of prescription drug costs—as well as the market structures that shape their prices, with a focus on the commercial market—to inform policymakers’ discussions around affordability and broader health care cost pressures on consumers. <Read More> 

A Look at Payers' Attitudes Toward Specialty Drug Management  – April 27, 2026 - Insurers are putting a growing focus on specialty drugs covered under the medical benefit, and on re-evaluating the efficacy of traditional rebate models, according to a new report. The Pharmaceutical Strategies Group (PSG) on Monday released its annual Trends in Specialty Drug Benefits report, which offers a look at how payers are responding to rising costs for these products and striking a balance between cost management and access. <Read More> 

New Study Underscores IRA’s Successes, Opportunities for Future Reforms – April 23, 2026 - A recent JAMA article found two key Inflation Reduction Act (IRA) prescription drug provisions that took effect in 2024—the elimination of coinsurance for catastrophic coverage and the expansion of the Part D low-income subsidy—improved medication adherence among Medicare beneficiaries. <Read More> 

Updated Endometriosis Guidelines: A Step Forward in Ethical Reproductive Healthcare – April 23, 2026 - New clinical guidelines for the diagnosis of endometriosis are welcome news. The guidelines, recently issued by the American College of Obstetricians and Gynecologists (ACOG), recommend that physicians treat patients as “partners and experts about their own bodies,” aligning with reproductive justice imperatives long overdue in the care of people with this common condition. <Read More>  

340B in the News

ASCO Updates 340B Policy Statement to Expand Access, Improve Transparency – May 6, 2026 - For the first time since 2014, the American Society of Clinical Oncology (ASCO) has updated its policy statement on the 340B Drug Pricing Program. The statement was published in JCO Oncology Practice…The new recommendations included in the policy statement are intended to expand practice eligibility, ensure benefit to the intended patients, and address any potential abuses. <Read More>  

The Fight Over 340B: Why a Little-Known Drug Program Matters for Black and Low-Income Patients – May 6, 2026 - Nearly three miles from the halls of power in Washington, Howard University Hospital operates at the intersection of policy and reality—where decisions made on Capitol Hill carry real consequences for patients and their families. Designated by the federal government as a disproportionate share hospital, Howard reflects the very mission behind the federal 340B drug pricing program. For decades, 340B has allowed safety-net providers to stretch limited resources by purchasing discounted medications and reinvesting those savings into patient care. <Read More>  

Read More

Clinical Insights: May 15th, 2026

New Drug/Vaccine Approval

Veppanu™ (vepdegestrant) Tablets – New Drug Approval – May 1, 2026 - Arvinas, Inc. (Nasdaq: ARVN), with its partner Pfizer Inc. (NYSE: PFE), announced that the U.S. Food and Drug Administration (FDA) has granted approval for Veppanu™ (vepdegestrant) for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. This approval marks the first time the FDA has approved a PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader therapy. <Read More>

Otarmeni™ (lunsotogene parvec-cwha) Suspension for Intracochlear Infusion – New Drug Approval – April 23, 2026 - The U.S. Food and Drug Administration approved Otarmeni™ (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy. Otarmeni™ is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene. <Read More> 

Idvynso™ (doravirine and islatravir) Tablets – New Drug Approval – April 20, 2026 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) approved Idvynso™, a new, two-drug single-tablet regimen of 100 mg doravirine and 0.25 mg islatravir, for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine. <Read More> 

New Label Expansions

Ocrevus® (ocrelizumab) Injection – New Label Expansion – Patient Population Altered: May 8, 2026 – Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), has received U.S. Food and Drug Administration (FDA) approval of Ocrevus® (ocrelizumab) intravenous (IV) infusion for the treatment of relapsing-remitting multiple sclerosis (RRMS) in pediatric patients 10 years of age and older who weigh 55 pounds (25 kg) or more. <Read More> 

Vyvgart® (efgartigimod alfa-fcab) Injection – New Label Expansion – New Indication Approved: May 8, 2026 - argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced the U.S. Food and Drug Administration (FDA) approved a label expansion for Vyvgart® (efgartigimod alfa-fcab) and Vyvgart Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG). <Read More> 

Bizengri® (zenocutuzumab-zbco) Injection – New Label Expansion – New Indication Approved: May 8, 2026 – Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has awarded a Commissioner’s National Priority Voucher (CNPV) pilot program voucher for Bizengri® (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. <Read More> 

Jakafi™ (ruxolitinib) Tablets - New Label Expansion – New Dosage Form Approved: May 1, 2026 - Incyte (Nasdaq:INCY) announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis (MF); adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy. <Read More> 

Asceniv™ (immune globulin intravenous, human – slra) Injection - New Label Expansion – Patient Population Altered: April 30, 2026 – ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, announced the U.S. Food and Drug Administration (“FDA”) has approved the Company’s supplemental Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act for Asceniv™. <Read More> 

Auvelity® (dextromethorphan and bupropion) Extended-Release Tablets – New Label Expansion – New Indication Approved: April 30, 2026 – The U.S. Food and Drug Administration approved an expanded use for Auvelity® (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults. The drug is the first FDA-approved treatment for this condition that is not an antipsychotic. FDA initially approved Auvelity® in 2022 to treat major depressive disorder in adults. <Read More> 

Breztri Aerosphere® (budesonide/glycopyrrolate/formoterol fumarate) Inhalation Aerosol – New Label Expansion – Patient Population Altered: April 27, 2026 – AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere® (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) has been approved in the US for the maintenance treatment of asthma in adult and paediatric patients 12 years of age and older. Breztri® is a single-inhaler that combines the efficacy of corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines with a long-acting muscarinic antagonist (LAMA). <Read More> 

Caplyta® (lumateperone) Capsules – New Label Expansion – Labeling Revision Approved: April 24, 2026 - Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on long-term data evaluating the safety and efficacy of Caplyta® (lumateperone) for the prevention of relapse in schizophrenia. <Read More> 

Saphnelo® (anifrolumab-fnia) Injection – New Label Expansion – New Dosage Form Approved: April 24, 2026 – AstraZeneca’s Saphnelo® (anifrolumab) has been approved in the US for self-administration as a once-weekly autoinjector, the Saphnelo® Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top of standard therapy. The approval by the US Food and Drug Administration (FDA) was based on results from the Phase III TULIP-SC trial, which showed that subcutaneous (SC) administration of Saphneloâ led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe SLE while receiving standard therapy. <Read More>

Dupixent® (dupilumab) Injection – New Label Expansion – Patient Population Altered: April 22, 2026 – The US Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of children aged two to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamine (H1AH) treatment. This expands the previous approval for Dupixent® in adults and adolescents aged 12 years and older with CSU. <Read More> 

Tzield® (teplizumab-mzwv) Injection – New Label Expansion – New Indication Approved: April 20, 2026 – The US Food and Drug Administration (FDA) has approved the supplemental biologic license application for Tzield® (teplizumab-mzwv), expanding the indication from eight years and older to as young as one year of age to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D. <Read More> 

Stelara® (ustekinumab) Injection – New Label Expansion – Patient Population Altered: April 15, 2026 – the U.S. Food and Drug Administration (FDA) approved Stelara® (ustekinumab) for the treatment of patients two years and older with moderately to severely active Crohn’s disease (CD). <Read More> 

Filspari® (sparsentan) Tablets – New Label Expansion – New Indication Approved: April 13, 2026 – Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that the U.S. Food and Drug Administration (FDA) has approved Filspari® (sparsentan) to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. Filspari® is the first and only medicine approved by the FDA for the treatment of FSGS, marking its expansion beyond IgA nephropathy (IgAN) into a second rare kidney disease. <Read More> 

Vabysmo® (faricimab-svoa) Intravitreal Injection – New Label Expansion – Labeling Revision Approved: April 9, 2026 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has received U.S. Food and Drug Administration (FDA) approval of Vabysmo® (faricimab-svoa) for the treatment of macular edema due to retinal vein occlusion (RVO) beyond six months. RVO affects over a million Americans and often involves long-term intravitreal therapy to address the chronic nature of the disease. <Read More> 

New Drug Shortage

May 08, 2026

May 07, 2026

May 06, 2026

May 05, 2026

April 29, 2026

Updated Drug Shortage

May 08, 2026

May 07, 2026

May 05, 2026

May 01, 2026

April 30, 2026

New Drug Recall and Safety Alerts

Lactated Ringer’s Injection, 1L, E7500 by B. Braun Medical, Inc. – New Voluntary Recall – April 28, 2026 - B. Braun Medical Inc. is voluntarily recalling two lots of Lactated Ringer’s Injection, E7500, 1L, to the hospital/healthcare facility level. The product has been found to have particulate matter in solution. <Read More> 

New Generic/Biosimilar Approval and Launch

Langlara™ (insulin glargine-aldy) Injection – New Lantus® Biosimilar Approval – April 29, 2026 - Lannett Company, Inc., Lanexa Biologics, a wholly owned subsidiary of Lannett, and Sunshine Lake Pharma announced that the U.S. Food and Drug Administration (FDA) has approved Langlara™ (insulin glargine-aldy), as a biosimilar to Lantus® (insulin glargine), for the treatment of adults and pediatric patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. The FDA has determined that Langlara™ is interchangeable with the reference drug, enabling pharmacists to substitute Langlara™ for Lantus® without prescriber intervention in states that permit such substitution. <Read More> 

Clinical and Pharmacy News

Nearly 3,000 Peer-Reviewed Medical Papers Have Fake Citations, a Columbia Nursing AI-Assisted Audit Finds – May 7, 2026 - A new Columbia University School of Nursing AI-assisted audit reveals nearly 3,000 peer-reviewed medical papers have fake citations that do not exist in scientific databases. The results highlight an alarming trend in academic publishing as the use of AI grows. <Read More> 

Pulmonary Embolism Care Gets Major Update – May 2, 2026 - A new clinical practice guideline has outlined a comprehensive, evidence-based framework for evaluating and managing acute pulmonary embolism in adults. The guideline applies to patients aged 18 years and older and spans the full clinical course, from symptom onset through post-acute follow-up. <Read More> 

Americans’ Challenges With Health Care Costs – April 30, 2026 - For many years, KFF polling has found that the high cost of health care is a burden on U.S. families, and that health care costs factor into decisions about insurance coverage and care seeking. These costs also rank as the top financial worry for adults and their families. This data note summarizes recent KFF polling on the public’s experiences with health care costs. <Read More> 

Prescription Drug Affordability: Examining Select Price Drivers – April 27, 2026 - Prescription drug prices heavily influence the public’s perception of health care affordability. A range of market, regulatory, and structural factors shape the timing and strength of competition in prescription drug markets, including the entry and uptake of generics and biosimilars. Even modest delays contribute to higher spending and slower realization of savings for consumers and taxpayers. This brief examines several drivers of prescription drug costs—as well as the market structures that shape their prices, with a focus on the commercial market—to inform policymakers’ discussions around affordability and broader health care cost pressures on consumers. <Read More> 

A Look at Payers' Attitudes Toward Specialty Drug Management  – April 27, 2026 - Insurers are putting a growing focus on specialty drugs covered under the medical benefit, and on re-evaluating the efficacy of traditional rebate models, according to a new report. The Pharmaceutical Strategies Group (PSG) on Monday released its annual Trends in Specialty Drug Benefits report, which offers a look at how payers are responding to rising costs for these products and striking a balance between cost management and access. <Read More> 

New Study Underscores IRA’s Successes, Opportunities for Future Reforms – April 23, 2026 - A recent JAMA article found two key Inflation Reduction Act (IRA) prescription drug provisions that took effect in 2024—the elimination of coinsurance for catastrophic coverage and the expansion of the Part D low-income subsidy—improved medication adherence among Medicare beneficiaries. <Read More> 

Updated Endometriosis Guidelines: A Step Forward in Ethical Reproductive Healthcare – April 23, 2026 - New clinical guidelines for the diagnosis of endometriosis are welcome news. The guidelines, recently issued by the American College of Obstetricians and Gynecologists (ACOG), recommend that physicians treat patients as “partners and experts about their own bodies,” aligning with reproductive justice imperatives long overdue in the care of people with this common condition. <Read More>  

340B in the News

ASCO Updates 340B Policy Statement to Expand Access, Improve Transparency – May 6, 2026 - For the first time since 2014, the American Society of Clinical Oncology (ASCO) has updated its policy statement on the 340B Drug Pricing Program. The statement was published in JCO Oncology Practice…The new recommendations included in the policy statement are intended to expand practice eligibility, ensure benefit to the intended patients, and address any potential abuses. <Read More>  

The Fight Over 340B: Why a Little-Known Drug Program Matters for Black and Low-Income Patients – May 6, 2026 - Nearly three miles from the halls of power in Washington, Howard University Hospital operates at the intersection of policy and reality—where decisions made on Capitol Hill carry real consequences for patients and their families. Designated by the federal government as a disproportionate share hospital, Howard reflects the very mission behind the federal 340B drug pricing program. For decades, 340B has allowed safety-net providers to stretch limited resources by purchasing discounted medications and reinvesting those savings into patient care. <Read More>  

Read More

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

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