Clinical Insights: June 26, 2024

Clinical Insights: August 7, 2024

Clinical Insights: July 24, 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

Kisunla™ (donanemab-azbt) Injection – New Drug Approval – July 2, 2024 – The U.S. Food and Drug Administration has approved Kisunla™ (donanemab-azbt) injection for the treatment of Alzheimer’s disease. Treatment with Kisunla™ should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in the clinical trials. Kisunla™ is administered as an intravenous infusion every four weeks. <Read More> Ohtuvayre™ (ensifentrine) Inhalation Suspension – New Drug Approval – June 26, 2024 – Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the US Food and Drug Administration (“FDA”) approved Ohtuvayre™ (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre™ is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years. Ohtuvayre™ is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre™ is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination. <Read More> Tepylute™ (thiotepa) Injection – New Drug Approval – June 25, 2024 – The US Food and Drug Administration (FDA) has approved specialty pharmaceutical company Shorla Oncology’s new drug application (NDA) for Tepylute™, a new formulation to treat breast and ovarian cancer. Tepylute™ is the third drug in the company’s portfolio to obtain FDA approval, with several other cancer drugs awaiting approval for the US market. Previously known as SH-105, the asset is a ready-to-dilute, injectable product that simplifies preparation and ensures dosing accuracy for breast and ovarian cancer treatments. <Read More> PiaSky® (crovalimab-akkz) Injection – New Orphan Drug Approval – June 24, 2024 - The U.S. Food and Drug Administration (FDA) has approved PiaSky® (crovalimab-akkz) for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg. <Read More>

New Indication/Dosage/Formulation Approval

Zoryve® (roflumilast) Cream and Foam – New Label Expansion – July 9, 2024 – Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Zoryve® (roflumilast) cream, 0.15%, for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. Zoryve® is a once-daily, steroid-free cream that provides rapid disease clearance and significant reduction in itch and has been specifically developed to be a treatment option for long-term disease control. <Read More> Vabysmo® (faricimab-svoa) Intravitreal Injection – New Label Expansion – July 3, 2024 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced the U.S. Food and Drug Administration (FDA) has approved the Vabysmo® (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect close to three million people in the U.S. The Vabysmo® PFS will become available to U.S. retina specialists and their patients in the coming months. <Read More> Epkinly™ (epcoritamab-bysp) Injection – New Label Expansion – June 26, 2024 – The Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly™, Genmab US, Inc.), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. <Read More>

New Drug Shortage

July 17, 2024

July 12, 2024

July 11, 2024

July 03, 2024

July 02, 2024

Updated Drug Shortage

July 19, 2024

July 18, 2024

July 17, 2024

July 16, 2024

July 15, 2024

New Drug Recall and Safety Alerts

Clonazepam Orally Disintegrating Tablets, USP (C-IV) by Endo USA, Inc. – New Voluntary Recall – July 16, 2024 - Endo, Inc (OTCQX: NDOI) (“Endo”), announced that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125 tablets 60-count pack to the consumer level. The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125 mg and not 0.25 mg due to an error at a third-party packager. <Read More> Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K by American Health Packaging on Behalf of BluePoint Laboratories – New Voluntary Recall – June 26, 2024 - American Health Packaging on behalf of BluePoint Laboratories is voluntarily recalling 21 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution. <Read More> Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K by Glenmark Pharmaceuticals Inc – New Voluntary Recall – June 24, 2024 - Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ is voluntarily recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution. <Read More>

New Generic/Biosimilar Approval and Launch

Pyzchiva® (ustekinumab-ttwe) Injection - New Biosimilar Approval – June 28, 2024 – Sandoz, the global leader in generic and biosimilar medicines, announced that the US Food and Drug Administration (FDA) has approved biosimilar Pyzchiva® (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion. Developed by Samsung Bioepis Co., Ltd, it is approved for all indications of its reference medicine and will be commercialized by Sandoz in the US. In addition, the FDA provisionally determined that Pyzchiva® would be interchangeable with the reference medicine as it is currently subject to an unexpired period of exclusivity for the first interchangeable biosimilar biological products… Pyzchiva® is approved by the FDA for all indications of the reference medicine Stelara® (ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist. <Read More> Ahzantive® (aflibercept-mrbb) Injection - New Biosimilar Approval – June 28, 2024 – Formycon AG (FSE: FYB, “Formycon”) and its licensing partner Klinge Biopharma GmbH (“Klinge”) announce that the U.S. Food and Drug Administration (“FDA”) approved FYB203/Ahzantive® (aflibercept-mrbb), a biosimilar to Eylea®. FYB203/Ahzantive® obtained FDA approval for the treatment of patients with neovascular Age-Related (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO). <Read More> Nypozi® (filgrastim-txid) Injection – New Biosimilar Approval – June 28, 2024 – The FDA approved Tanvex’s Nypozi® (filgrastim-txid), biosimilar to Amgen’s Neupogen™ (filgrastim). Nypozi® is the fourth FDA-approved biosimilar to Neupogen™. Zarxio® (filgrastim-sndz), Nivestym® (filgrastim-aafi) and Releuko® (filgrastim-ayow) have all previously launched. <Read More>

Clinical and Pharmacy News

AI Will Change Pharmacy; Pharmacists Must Step Up Now – July 17, 2024 – At the first-ever ASHP Artificial Intelligence Summit, in Portland, Ore., pharmacy leaders discussed innovative uses of the technology. “I see tremendous opportunity for the digital enhancement of medication management, pharmacy practice and healthcare as a whole,” Lisa Stump, MS, the chief information officer at Yale Medicine and Yale New Haven Health, in Connecticut, said to kick off the summit. Although definitions of AI vary, ASHP uses a version from the Oxford English Dictionary: “The capacity of computers or other machines to exhibit or simulate intelligent behavior.” AI systems use mathematics to, for example, make predictions of the next word in a string of words, or deduce whether an image is a dog or cat, based on training data that humans have given it. The training data can have few variables or many. It enables AI to spot patterns such as changes to the timbre of someone’s voice or fluctuations in their blood pressure. <Read More> CGTs ‘a Big Deal for Pharmacy,’ So Getting Payment Right is Crucial – July 17, 2024 - A growing number of cell and gene therapies offer significant symptom relief—and in some cases, even cures—for a wide range of often debilitating conditions. But at millions of dollars per dose, CGT treatments pose demanding procurement and reimbursement challenges for U.S. hospitals that are qualified to administer them. Several health systems are rising to that challenge. Some are partnering with consultants with proven expertise in securing prior authorizations for CGTs. Others have developed in-house pharmacy and therapeutics (P&T) committees that specialize in managing CGTs. The common thread to these efforts is having clearly defined processes for clearing the considerable clinical, financial and operational hurdles posed by these groundbreaking therapies. <Read More> FTC Reportedly to Sue Three Largest Pharmacy Benefit Managers – July 11, 2024 – The Federal Trade Commission is preparing to sue the largest three pharmacy benefit managers over their negotiations over the prices for drugs including insulin, The Wall Street Journal reported on Wednesday. The FTC plans to file lawsuits related to rebates brokered with drug manufacturers, people familiar with the matter told the WSJ. The three largest PBMs are UnitedHealth Group's OptumRx, Cigna's Express Scripts and CVS Health's CVS Caremark. These three account for an estimated 80% of prescriptions. The news of a lawsuit comes on the heels of an FTC report on pharmacy benefit managers. The FTC did a two-year investigation into their practices and released the FTC report, "Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies." <Read More> An Examination of the Cholesterol Hypothesis – July 11, 2024 – Most cardiologists and lipid experts have long subscribed to the “cholesterol hypothesis” (also called “lipid hypothesis”). The cholesterol hypothesis, simply stated, is that an elevated blood level of LDL cholesterol is a direct cause of atherosclerosis, a progressive disease where arteries become clogged with plaque. As a result, the medical community’s consensus has been to help people reduce LDL cholesterol levels to lower the risk of atherosclerotic cardiovascular disease. However, more recently, experts have been questioning the cholesterol hypothesis. This article explains the theory, its implications, and factors besides cholesterol that researchers are considering. <Read More> Alzheimer's: Revised Diagnostic Criteria Place Blood Biomarkers at the Forefront – July 4, 2024 – About 32 million people around the world are currently living with Alzheimer’s disease. Better outcomes are linked to early Alzheimer’s disease diagnosis. A workgroup from the Alzheimer’s Association has published revised criteria for the diagnosis and staging of the condition based on the biology of the disease and the latest research. <Read More> Daily Aspirin Use Among Older Adults Remains Prevalent Despite Potential Risks – July 2, 2024 – Aspirin is a common over-the-counter medication that can help relieve pain and reduce the risk of blood clots. Past recommendations have included taking aspirin to help prevent cardiovascular disease. Recent guidance indicates that adults over 70 should not use aspirin for primary prevention of heart disease. A recent survey found the number of adults using aspirin to prevent heart disease has decreased, but around one-third of adults ages 60 and older without heart disease were still taking aspirin, some without medical advice. <Read More>

340B in the News

Protecting Federally Qualified Health Centers Amid Drugstore Closures and Threats to 340B – July 15, 2024 - In January 2024, a Walgreens location in Roxbury, Massachusetts, a predominantly Black and Latinx neighborhood in Boston, closed despite local grassroots activism and congressional support to keep it open. The shuttered store follows a series of Walgreens closures in the Roxbury, Mattapan, and Hyde Park neighborhoods of Boston… Unfortunately, proposed restrictions on the number of pharmacies that can partner with 340B-covered entities is an emerging challenge to improving pharmacy access. When FQHCs do not have an in-house pharmacy or when their patient base is spread across a wider geographic area, they typically contract with multiple pharmacies in various locations to provide the most convenience to their patients. Patients can then choose which pharmacy to pick up their medications. <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

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June 15, 2026

Updated Drug Shortage

July 04, 2026

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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: 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

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May 14, 2026

Updated Drug Shortage

June 09, 2026

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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>  

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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