Clinical Insights: July 10th, 2025

Clinical Insights: September 10th, 2025

Clinical Insights: August 6th, 2025

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

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

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

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

New Label Expansions

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

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

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

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

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

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

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

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

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

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

New Drug Shortage

August 4, 2025

August 1, 2025

July 29, 2025

July 28, 2025

July 24, 2025

July 23, 2025

July 21, 2025

July 17, 2025

Updated Drug Shortage

August 4, 2025

August 1, 2025

July 31, 2025

July 28, 2025

July 25, 2025

July 24, 2025

July 23, 2025

July 22, 2025

July 18, 2025

July 17, 2025

New Drug Recall and Safety Alerts

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

New Generic/Biosimilar Approval and Launch

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

Clinical and Pharmacy News

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

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

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

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

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

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

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

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

340B in the News

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


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>  

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Clinical Insights: April 16th, 2026

New Drug/Vaccine Approval

Foundayo™ (orforglipron) Tablets – New Drug Approval – April 1, 2026 - Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved Foundayo™ (orforglipron) for adults with obesity, or overweight with weight-related medical problems. When used alongside a reduced-calorie diet and increased physical activity, Foundayo™ helps individuals lose excess body weight and keep the weight off. Foundayo™ will be available via LillyDirect®, with prescriptions accepted immediately and shipping beginning April 6, followed shortly after by broad availability through U.S. retail pharmacies and telehealth providers. <Read More>

Awiqli® (insulin icodec-abae) Injection – New Drug Approval – March 26, 2026 - Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Awiqli® (insulin icodec-abae) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycaemic control (blood sugar) in adults living with type 2 diabetes. The approval offers the only once‑weekly basal insulin option, providing a new treatment solution that fits different patient routines and preferences for adults living with type 2 diabetes. <Read More> 

Kresladi™ (marnetegragene autotemcel) Suspension for Intravenous Infusion – New Drug Approval – March 26, 2026 - The U.S. Food and Drug Administration approved Kresladi™ (marnetegragene autotemcel), the first gene therapy for the treatment of severe Leukocyte Adhesion Deficiency Type I (LAD-I). Kresladi™ is indicated for the treatment of pediatric patients with severe leukocyte adhesion deficiency I (LAD-I) due to biallelic variants in ITGB2 without an available human leukocyte antigen (HLA)-matched sibling donor for allogeneic hematopoietic stem cell transplant. <Read More> 

Lifyorli™ (relacorilant) Capsules – New Drug Approval – March 25, 2026 - The Food and Drug Administration approved relacorilant (Lifyorli™, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. <Read More> 

Avlayah™ (tividenofusp alfa-eknm) Lyophilized Powder for Injection – New Drug Approval – March 24, 2026 - Denali Therapeutics Inc. (Nasdaq: DNLI) announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Avlayah™ (tividenofusp alfa-eknm), the first FDA-approved biologic specifically designed to cross the blood-brain barrier and reach the whole body, including the brain. Avlayah™ is an enzyme replacement therapy indicated for the treatment of neurologic manifestations of Hunter syndrome (mucopolysaccharidosis type II, or MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial. <Read More> 

Lynavoy™ (linerixibat) Tablets – New Drug Approval – March 17, 2026 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Lynavoy™ (linerixibat) for the treatment of cholestatic pruritus in adult patients with PBC. Lynavoy™, an ileal bile acid transporter (IBAT) inhibitor that reduces multiple drivers of chronic itch, is the first medicine approved in the US for this indication. <Read More> 

Icotyde™ (icotrokinra hydrochloride) Tablets – New Drug Approval – March 17, 2026 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Icotyde™ (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. Icotyde™ is the first and only targeted oral peptide that precisely blocks the IL-23 receptor. <Read More> 

Yuviwel® (navepegritide) Lyophilized Powder for Injection - formerly TransCon CNP – New Drug Approval – February 27, 2026 - Ascendis Pharma A/S (Nasdaq: ASND) announced that the U.S. Food & Drug Administration (FDA) has granted approval under the FDA’s Accelerated Approval Program for Yuviwel® (navepegritide; developed as TransCon® CNP), the first and only once-weekly treatment indicated to increase linear growth in children 2 years of age and older with achondroplasia with open epiphyses and the only one to provide continuous systemic exposure to CNP over the weekly dosing interval. Continued approval for this indication, which was based on an improvement in annualized growth velocity (AGV), may be contingent upon verification and description of clinical benefit in confirmatory trial(s). <Read More> 

Desmoda™ (desmopressin acetate) Oral Solution - formerly ET-600 – New Drug Approval – February 25, 2026 - Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced the U.S. Food and Drug Administration (FDA) approval of a New Drug Application (NDA) for Desmoda™ (desmopressin acetate) Oral Solution for the management of central diabetes insipidus, also known as arginine vasopressin deficiency (AVP-D), as antidiuretic replacement therapy for patients of all ages. <Read More> 

Loargys® (pegzilarginase-nbln) Injection – New Drug Approval – February 23, 2026 - Immedica Pharma announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Loargys® (pegzilarginase-nbln), an arginine specific enzyme indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction. <Read More> 

Bysanti™ (milsaperidone) Tablets – New Drug Approval – February 20, 2026 - Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced that the U.S. Food and Drug Administration (FDA) has approved Bysanti™ (milsaperidone) tablets, a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. <Read More> 

New Label Expansions

Eylea HD® (aflibercept) Injection – New Label Expansion – New Dosage Regimen: April 2, 2026 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved the extension of dosing intervals for Eylea HD® (aflibercept) up to every 20 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) following one year of successful response based on visual and anatomic outcomes. As part of the approval, the FDA has updated the Eylea HD® label to include 96-week (2-year) data from the pivotal PULSAR trial in wAMD and the pivotal PHOTON trial in DME, demonstrating sustained efficacy and safety through 2 years with extended dosing intervals. <Read More> 

Tecartus® (brexucabtagene autoleucel) Suspension for Intravenous Infusion – New Label Expansion – Labeling Revision Approved: April 1, 2026 - The U.S. Food and Drug Administration (FDA) has granted traditional (full) approval to Kite’s CAR T-cell therapy, Tecartus® (brexucabtagene autoleucel), for adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). The full approval now includes efficacy, safety and pharmacokinetic data from Cohort 3 of the ZUMA-2 study in patients who are R/R after one or more lines of therapy and who are Bruton tyrosine kinase inhibitor (BTKi)-naïve. <Read More> 

Spinraza® (nusinersen) Injection – New Label Expansion – New Dosage Regimen: March 27, 2026 - Biogen Inc. (Nasdaq: BIIB) announced that the High Dose Regimen of Spinraza® (nusinersen), which is comprised of 50 mg/5 mL and 28 mg/5 mL doses, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of spinal muscular atrophy (SMA). Backed by more than 10 years of clinical data supporting the Low Dose Regimen of Spinraza® (12 mg), High Dose Spinraza® was designed to deliver a higher concentration of drug through both the loading and maintenance dosing phases, to provide a new option in response to the ongoing needs of the community. <Read More>  

Alyftrek® (deutivacaftor, tezacaftor and vanzacaftor) – New Label Expansion – Labeling Revision Approved: March 27, 2026 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced the U.S. Food and Drug Administration (FDA) has approved expanded use of Alyftrek® (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of people with cystic fibrosis (CF) ages 6 and older with a variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. Additionally, the U.S. FDA has also expanded the indication statement for Trikafta® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 2 and older. <Read More> 

neffy® (epinephrine) Nasal Spray – New Label Expansion – Labeling Revision Approved: March 26, 2026 - ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, announced that the U.S. Food and Drug Administration (FDA) has approved updating the neffy® 1 mg (epinephrine nasal spray) prescribing information to remove the age criteria so all children and adults who weigh 33 lbs. or more can utilize neffy® for the emergency treatment of Type 1 allergic reactions, including anaphylaxis. Prior to the update, pediatric patients needed to meet a weight requirement and be at least four years of age. <Read More>  

Adstiladrin® (nadofaragene firadenovec-vncg) Suspension for Intravesical Use – New Label Expansion – Labeling Revision Approved: March 23, 2026 - Ferring Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Adstiladrin® (nadofaragene firadenovec-vncg), enabling an accelerated water-bath thawing method, completed in about 25 minutes, to enhance efficient clinical preparation for healthcare teams. <Read More> 

Opdivo® (nivolumab) Injection – New Label Expansion – New Indication Approved: March 20, 2026 - Bristol Myers Squibb (NYSE: BMY) announced that Opdivo® (nivolumab) has received approval for two new classical Hodgkin Lymphoma (cHL) indications in the U.S. and the European Union (EU). The U.S. Food and Drug Administration (FDA) granted approval of Opdivo® in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV cHL. <Read More> 

Imcivree® (setmelanotide) Injection – New Label Expansion – New Indication Approved: March 19, 2026 - Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for Imcivreeâ (setmelanotide) seeking approval for the treatment of conditions associated with acquired hypothalamic obesity. <Read More> 

Wegovy® (semaglutide) Injection and Tablets – New Label Expansion – New Dosage Form Approved: March 19, 2026 - The U.S. Food and Drug Administration approved a new higher dose (7.2 mg) of Wegovy® (semaglutide) injection, called Wegovy® HD, for weight loss and long-term maintenance of weight loss for certain adult patients. The decision was granted just 54 days after filing and represented the fourth approval under the Commissioner’s National Priority Voucher (CNPV) pilot program. <Read More>  

Cosentyx® (secukinumab) Injection – New Label Expansion – Patient Population Altered: March 13, 2026 - Novartis announced that Cosentyx® (secukinumab) received US Food and Drug Administration (FDA) approval for treating pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS), making it the only IL-17A inhibitor for this population. The approval of a distinct biologic option for pediatric patients living with HS allows treatment to be tailored to the individual and establishes Cosentyx® as a meaningful addition to the treatment landscape. <Read More> 

Arexvy™ (respiratory syncytial virus vaccine, adjuvanted) Suspension for Intramuscular Injection – New Label Expansion – Patient Population Altered: March 12, 2026 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has expanded the approved age indication of Arexvy™ (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV. Arexvy™ was previously approved in the US for the prevention of RSV-related LRTD in adults aged 60 and older, and adults aged 50–59 at increased risk for LRTD caused by RSV. This vaccine is not for use in pregnant individuals. <Read More> 

Wellcovorin™ (leucovorin calcium) Tablets – New Label Expansion – New Indication Approved: March 9, 2026 - The U.S. Food and Drug Administration approved expanded use of Wellcovorin™ (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1). <Read More> 

Pylarify™ (piflufolastat F 18) Injection – New Label Expansion – New Formulation Approved: March 6, 2026 - Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced that the U.S. Food and Drug Administration (FDA) has approved Pylarify TruVu™ (piflufolastat F 18) injection, a new formulation of its F 18 prostate-specific membrane antigen (PSMA) imaging agent. Pylarify TruVu™ is indicated for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. <Read More>

Sotyktu® (deucravacitinib) Tablets – New Label Expansion – New Indication Approved: March 6, 2026 - Bristol Myers Squibb (NYSE:BMY) announced that the U.S. Food and Drug Administration (FDA) has approved Sotyktu® (deucravacitinib) for the treatment of adults with active psoriatic arthritis (PsA). Sotyktu®, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, is the first TYK2 inhibitor to be approved for PsA. <Read More> 

Tecvayli® (teclistamab-cqyv) Injection – New Label Expansion – New Indication Approved: March 5, 2026 - Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, announced that the U.S. Food and Drug Administration (FDA) approved Tecvayli® (teclistamab-cqyv) plus Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. <Read More> 

Palynziq® (pegvaliase-pqpz) Injection – New Label Expansion – Patient Population Altered: February 27, 2026 - BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for Palynziq® (pegvaliase-pqpz) to include pediatric patients 12 years of age and older with phenylketonuria (PKU). Palynziq® is the only enzyme substitution therapy approved to reduce blood phenylalanine (Phe) concentrations in people with PKU. <Read More>  

Sogroya® (somapacitan-beco) Injection – New Label Expansion – Patient Population Altered: February 27, 2026 - Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved three new indications for once-weekly Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg, a long-acting growth hormone. Sogroya® is now indicated for children aged 2.5 years and older with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome (NS). Sogroya® is also indicated for children aged 2.5 years and older and adults with growth hormone deficiency (GHD). <Read More> 

Hernexeos® (zongertinib) Tablets – New Label Expansion – New Indication Approved: February 26, 2026 - The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim’s Hernexeos® (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. This indication is approved under accelerated approval based on objective response rate and duration of response. <Read More> 

Juxtapid® (lomitapide) Capsules – New Label Expansion – Patient Population Altered: February 25, 2026 - Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Juxtapid® (lomitapide) capsules for pediatric use in homozygous familial hypercholesterolemia (HoFH) for children 2 years of age and older. Juxtapid® is a proven therapy that has been approved in the United States for adult patients with HoFH to be used along with diet and other lipid-lowering treatments, since 2012. <Read More> 

Braftovi® (encorafenib) Capsules – New Label Expansion – New Indication Approved: February 24, 2026 - Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Braftovi® (encorafenib) in combination with cetuximab (marketed as Erbitux®) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation based on results from the global Phase 3 BREAKWATER trial. <Read More>  

Dupixent® (dupilumab) Injection – New Label Expansion – New Indication Approved: February 23, 2026 - The US Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. The FDA evaluated Dupixent® under priority review for the treatment of AFRS, which is reserved for medicines that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. This approval expands our approved indications in sino-nasal diseases to now include AFRS, alongside chronic rhinosinusitis with nasal polyps. <Read More> 

Elucirem™ (gadopiclenol) Injection – New Label Expansion – Patient Population Altered: February 20, 2026 - Guerbet, a global specialist in contrast media and solutions for medical imaging, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved a labeling update for Elucirem™ (gadopiclenol) injection. The new indication includes approval for pediatric patients aged 0-2 years (including term neonates) for its macrocyclic high-relaxivity gadolinium-based contrast agent. <Read More>  

Calquence® (acalabrutinib) Capsules and Tablets – New Label Expansion – New Indication Approved: February 19, 2026 - AstraZeneca’s Calquence® (acalabrutinib) in combination with venetoclax has been approved in the US as the first all-oral, fixed-duration regimen for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The approval by the US Food and Drug Administration (FDA) was based on positive results from the AMPLIFY Phase III trial, which were presented at the American Society of Hematology 2024 Annual Meeting and published in The New England Journal of Medicine. <Read More> 

Wakix® (pitolisant) Tablets – New Label Expansion – Patient Population Altered: February 13, 2026 - Harmony Biosciences (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for Wakix® (pitolisant) tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. Wakix® is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult narcolepsy patients with or without cataplexy. <Read More> 

Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) Injection – New Label Expansion – New Dosage Regimen: February 13, 2026 - Johnson & Johnson (NYSE: JNJ) announced the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule for Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj). When administered in combination with oral Lazcluze® (lazertinib) for the first-line treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC), monthly dosing delivers consistent outcomes with the previously approved bi-weekly subcutaneous (SC) dosing schedule. <Read More> 

Enzeevu® (aflibercept-abzv) Injection – New Label Expansion – New Indication Approved: February 12, 2026 - Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, announced that the US Food and Drug Administration (FDA) has approved an expanded label for Enzeevu® (aflibercept-abzv), to include multiple retinal indications. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – New Indication Approved: February 10, 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) plus paclitaxel, with or without bevacizumab, for the treatment of adults with PD-L1+ (Combined Positive Score [CPS] ≥1), as determined by an FDA-authorized test, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received one or two prior systemic treatment regimens. <Read More>  

Yescarta® (axicabtagene ciloleucel) Suspension for Intravenous Infusion – New Label Expansion – Labeling Revision Approved: February 5, 2026 - Kite, a Gilead Company (Nasdaq: GILD), announced the U.S. Food and Drug Administration (FDA) approved an update to the Yescarta® (axicabtagene ciloleucel) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL).

Ozempic® (semaglutide) Injection and Tablets – New Label Expansion – Labeling Revision Approved: January 30, 2026 – Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Ozempic® (semaglutide) tablets 1.5 mg, 4 mg, and 9 mg as the name for oral semaglutide 1.5 mg, 4 mg, and 9 mg. The active ingredient remains the same semaglutide molecule, and the Ozempic® pill is FDA-approved for use in adults with type 2 diabetes to improve blood sugar along with diet and exercise, and to reduce the risk of major adverse cardiovascular events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes who are at high risk for these events. <Read More> 

New Drug Shortage

April 10, 2026

April 09, 2026

April 08, 2026

April 07, 2026

April 06, 2026

Updated Drug Shortage

April 10, 2026

April 09, 2026

April 08, 2026

April 07, 2026

April 06, 2026

New Drug Recall and Safety Alerts

Wound Care Gel Products by Blaine Labs, Inc - New Voluntary Recall – April 8, 2026 - Blaine Labs, Inc. is voluntarily recalling three (3) lot numbers of Wound Care Gel products, 1 oz. & 3 oz. (0.1% Benzalkonium Chloride) to the consumer level due to microbial contamination. The affected product has been found to contain Lysinibacillus fusiformis, an environmental organism. <Read More> 

Magnesium Sulfate in Water for Injection, USP 4 g/100mL (NDC 70121-1720-3) by Amneal Pharmaceuticals LLC – New Voluntary Recall – March 24, 2026 - Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag, to the hospital level. A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL. <Read More> 

Webcol™ Large Alcohol Prep Pad by Cardinal Health – New Voluntary Recall – March 19, 2026 - Cardinal Health has issued a voluntary recall for select lots of Webcol™ Large Alcohol Prep Pads (70% isopropyl alcohol) to the consumer level. The product is being recalled due to microbial contamination identified as Paenibacillus phoenicis. <Read More> 

New Generic/Biosimilar Approval and Launch

Ponlimsi™ (denosumab-adet) Injection – New Prolia® Biosimilar Approval – March 27, 2026 - Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced milestones in its biosimilar portfolio, demonstrating continued momentum in the advancement of its Pivot to Growth strategy. The United States (U.S.) Food and Drug Administration (FDA) has approved Ponlimsiä (denosumab-adet) as a biosimilar to Prolia®. <Read More> 

Clinical and Pharmacy News

Questioning the Prescription: Antidepressants and the Medicalization of Childhood – April 10, 2026 – This week Mad in America explores four recently published articles related to antidepressant use in children and adolescents. The first reports that although clinical trials have found little efficacy for the use of fluoxetine (Prozac®) as a treatment for depression in children, clinical guidelines still recommend it. The second finds that persistent antidepressant use is common and rising in Australian children… <Read More> 

Under the Magnifying Glass: A Wave of Drug Price Transparency – April 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). <Read More> 

How Hospital Pharmacies Can Access Restrictive Specialty Networks – March 2, 2026 - As payors and pharmacy benefit managers (PBMs) narrow specialty pharmacy networks, health system pharmacies face increasing exclusion from dispensing high-cost therapies to their own patients. For many organizations, accessing these restrictive networks has become both a strategic imperative and an operational challenge. Signature Healthcare, a regional health system in southern Massachusetts, addressed this challenge by partnering with Clearway Health, a specialty pharmacy services organization that originated from Boston Medical Center Health System. Clearway Health now collaborates with hospitals nationwide to improve access to care for patients requiring complex, high-cost medications. <Read More> 

As Rare Disease Drug Approvals Accelerate, Survey Highlights Gaps in Care Coordination – March 2, 2026 - As the pipeline for rare disease therapies continues to expand, new survey data suggest that the healthcare system is not keeping pace with the coordination demands required to deliver those treatments effectively. A national survey commissioned by PANTHERx Rare and conducted by Morning Consult found that patients, caregivers, and healthcare professionals perceive wide gaps in rare disease care delivery, whereas payors view care coordination far more favorably. Among patients and caregivers, 76% rated the current rare disease care system as average, below average, or poor, with 44% describing it as poor. Healthcare professionals were even more critical: 86% rated the system as average or worse, and 50% described it as poor. In contrast, a majority of payors (58%) rated the system as good, revealing what the report describes as a stakeholder disconnect. <Read More> 

Pharmacist Welcomes Bill Restricting Pharmacy Benefit Managers; CVS Projects Mass Closures – February 25, 2026 - Tennessee’s Senate Health and Welfare Committee considered a bill to place restrictions on pharmacy benefit managers (PBMs) on Wednesday. According to the American Medical Association, a pharmacy benefit manager is a middleman in the prescription drug supply chain. They manage prescription drug plan benefits for insurers and employers. PBMs negotiate rebates and discounts, put together networks, and conduct management tasks. Sen. Bobby Harshbarger (R-Kingsport), a pharmacist himself, proposed the bill known as the Fair Rx Act. Christian Tate, a pharmacist at Berry’s Pharmacy in Kingsport, said independent pharmacists just want an equal playing field, and the bill would be a step in the right direction. <Read More> 

Bridging the Gap in Biosimilar Use and Uptake in Inflammatory Conditions – February 24, 2026 - Within the last 5 years, the FDA has approved several key biosimilars for inflammatory conditions such as inflammatory bowel disease and rheumatologic disorders. Infliximab biosimilars entered the market in 2016 as IV infusions only and are billed through the medical benefit. In 2023 and 2025, adalimumab and ustekinumab biosimilars were approved, respectively. Adalimumab has 10 biosimilars, and ustekinumab has 7 on the market. Given that self-administered adalimumab and ustekinumab are billed through the pharmacy benefit, they introduce a new set of challenges and opportunities. This article addresses barriers that arise for the prescribing provider and team, including specialty pharmacists who manage biologic access in collaboration with the clinic, and provides recommendations for future biosimilar utilization. <Read More> 

ACC, AHA Release First-Ever Guideline for Treatment and Management of Acute PE – February 19, 2026 - The new “ACC/AHA Guideline for the Evaluation and Management of Acute Pulmonary Embolism (PE) in Adults” is a de novo document offering comprehensive, evidence‑based recommendations for the evaluation, management and follow‑up of adults with acute PE. Collaborated on and endorsed by an additional eight societies, the new guideline recognizes that management of patients with acute PE "is uniquely multidisciplinary and crosses emergency department, inpatient settings and outpatient clinics." <Read More> 

House Members Push for PBM Changes, Question Trump Drug Plan – February 11, 2026 - Lawmakers from both sides of the aisle on Wednesday came down hard on various sectors of the U.S. prescription drug supply chain during a hearing to shed light on the reasons for rising costs. At a House Energy and Commerce Health Subcommittee hearing, Rep. Brett Guthrie, R-Ky., touted changes in the fiscal 2026 spending package enacted this month to improve pharmacy-benefit manager pricing transparency and reduce incentives for PBMs to promote higher-priced drugs to Medicare Part D beneficiaries. But Guthrie stressed that further changes could be forthcoming. “Historic PBM reform is just the beginning,” said Guthrie, who chairs the full Energy and Commerce panel. “More needs to be done throughout the drug supply chain to improve affordability.” <Read More> 

340B in the News

AbbVie Challenges 'Outdated' 340B Drug Discount Program Guidance in New Lawsuit – April 9, 2026 - AbbVie is spearheading a new battle in pharma’s long-running fight to reform the federal government’s 340B drug discount program with a lawsuit that challenges the definition of what it means to be a “patient” under the program's framework. AbbVie, a three-decade participant in the 340B system, leveled the suit to “restore integrity” to the drug discount program, the company explained in its 72-page complaint against the Department of Health and Human Services (HHS) and its secretary Robert F. Kennedy Jr., plus the Department of Health Resources and Services Administration (HRSA) and administrator Thomas Engels. <Read More> 

Updates to 340B and What Pharmacists Need to Know – March 26, 2026 - The 340B Drug Pricing Program is a federally mandated drug pricing program created by Congress in 1992 that allows certain health care organizations (called covered entities) to purchase specific outpatient drugs at significantly discounted prices. The core intent is to help these providers “stretch scarce resources” so they can serve low-income and underserved patients, reach more patients, and provide more comprehensive services in their communities. However, despite its original intent, the program faces various challenges in the shape of manufacturer restrictions, legal and regulatory uncertainty, administrative burdens, and compliance risks. As restrictions, litigation, and reimbursement cuts stack up, 340B savings shrink. <Read More> 

Association Between 340B Contract Pharmacy Growth and Payer-Specific Drug Coverage – February 27, 2026 - The 340B Drug Pricing Program entitles participating hospitals and clinics (called covered entities) to purchase outpatient drugs at a substantial discount from manufacturers. Covered entities either distribute 340B drugs at reduced prices to patients or generate a subsidy by charging insured patients market prices for discounted drugs. Drugs purchased through 340B accounted for $66 billion in 2023, with approximately one-fifth of this sum coming from sales through unaffiliated community retail pharmacies, called contract pharmacies. We linked data on contract pharmacy locations to Managed Market Surveyor data to describe the markets in which 340B covered entities locate contract pharmacies. <Read More> 

Report Questions Drug Pricing as Supporters Defend 340B Program – February 19, 2026 - Hospitals and clinics in Michigan participating in a federal drug discount program are marking up medications and shifting costs onto public employee health plans, according to a new analysis. The report from IQVIA, a health data analytics and research company, found that providers participating in the federal 340B Drug Pricing Program are buying medications at steep discounts and billing insurers at much higher rates – increasing costs for both state health plans and taxpayers. <Read More> 

Trump Administration Restarts its Efforts to Pilot 340B Rebates – February 13, 2026 – Only a week after calling it quits on a court-halted pilot program, the Trump administration is already revving the engine on how it could test out a rebate model for the 340B Drug Discount program. The Health Resources and Services Administration (HRSA) released a request for information (RFI) asking stakeholders and the public for input on whether and how such a model should be implemented for 340B, which, for over 30 years, has required drug manufacturers to provide upfront discounts on their products to help subsidize safety-net care. <Read More> 

Following Legal Setbacks, HHS Agrees to Toss 340B Rebate Model Pilot Program – February 6, 2026 - The Department of Health and Human Services has officially backed down on its halted 340B Rebate Model Pilot Program, telling the courts this week that it plans to pull relevant notices and application approvals. Lawyers for the government and plaintiffs who sued to block the program—several hospitals and hospital groups including American Hospital Association (AHA)—filed Thursday afternoon in the U.S. District Court for the District of Maine a joint motion for vacatur and remand. <Read More> 

Site-of-Care Shift for Physician-Administered Drug Therapies: 2026 Update – January 2026 - Using new Medicare data, this paper updates a prior analysis1 evaluating the site of care for all Medicare Part B drug therapies and finds that previously observed trends are continuing. Specifically, 340B Drug Pricing Program hospital outpatient departments (HOPDs)—including both HOPDs at the hospital itself and off-campus locations—continue to represent a growing share of outpatient drug administrations. This analysis also examines how these trends are reflected in top drugs used to treat breast cancer, rheumatoid arthritis, and multiple myeloma. <Read More> 

Read More

Clinical Insights: April 16th, 2026

New Drug/Vaccine Approval

Foundayo™ (orforglipron) Tablets – New Drug Approval – April 1, 2026 - Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved Foundayo™ (orforglipron) for adults with obesity, or overweight with weight-related medical problems. When used alongside a reduced-calorie diet and increased physical activity, Foundayo™ helps individuals lose excess body weight and keep the weight off. Foundayo™ will be available via LillyDirect®, with prescriptions accepted immediately and shipping beginning April 6, followed shortly after by broad availability through U.S. retail pharmacies and telehealth providers. <Read More>

Awiqli® (insulin icodec-abae) Injection – New Drug Approval – March 26, 2026 - Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Awiqli® (insulin icodec-abae) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycaemic control (blood sugar) in adults living with type 2 diabetes. The approval offers the only once‑weekly basal insulin option, providing a new treatment solution that fits different patient routines and preferences for adults living with type 2 diabetes. <Read More> 

Kresladi™ (marnetegragene autotemcel) Suspension for Intravenous Infusion – New Drug Approval – March 26, 2026 - The U.S. Food and Drug Administration approved Kresladi™ (marnetegragene autotemcel), the first gene therapy for the treatment of severe Leukocyte Adhesion Deficiency Type I (LAD-I). Kresladi™ is indicated for the treatment of pediatric patients with severe leukocyte adhesion deficiency I (LAD-I) due to biallelic variants in ITGB2 without an available human leukocyte antigen (HLA)-matched sibling donor for allogeneic hematopoietic stem cell transplant. <Read More> 

Lifyorli™ (relacorilant) Capsules – New Drug Approval – March 25, 2026 - The Food and Drug Administration approved relacorilant (Lifyorli™, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. <Read More> 

Avlayah™ (tividenofusp alfa-eknm) Lyophilized Powder for Injection – New Drug Approval – March 24, 2026 - Denali Therapeutics Inc. (Nasdaq: DNLI) announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Avlayah™ (tividenofusp alfa-eknm), the first FDA-approved biologic specifically designed to cross the blood-brain barrier and reach the whole body, including the brain. Avlayah™ is an enzyme replacement therapy indicated for the treatment of neurologic manifestations of Hunter syndrome (mucopolysaccharidosis type II, or MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial. <Read More> 

Lynavoy™ (linerixibat) Tablets – New Drug Approval – March 17, 2026 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Lynavoy™ (linerixibat) for the treatment of cholestatic pruritus in adult patients with PBC. Lynavoy™, an ileal bile acid transporter (IBAT) inhibitor that reduces multiple drivers of chronic itch, is the first medicine approved in the US for this indication. <Read More> 

Icotyde™ (icotrokinra hydrochloride) Tablets – New Drug Approval – March 17, 2026 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Icotyde™ (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. Icotyde™ is the first and only targeted oral peptide that precisely blocks the IL-23 receptor. <Read More> 

Yuviwel® (navepegritide) Lyophilized Powder for Injection - formerly TransCon CNP – New Drug Approval – February 27, 2026 - Ascendis Pharma A/S (Nasdaq: ASND) announced that the U.S. Food & Drug Administration (FDA) has granted approval under the FDA’s Accelerated Approval Program for Yuviwel® (navepegritide; developed as TransCon® CNP), the first and only once-weekly treatment indicated to increase linear growth in children 2 years of age and older with achondroplasia with open epiphyses and the only one to provide continuous systemic exposure to CNP over the weekly dosing interval. Continued approval for this indication, which was based on an improvement in annualized growth velocity (AGV), may be contingent upon verification and description of clinical benefit in confirmatory trial(s). <Read More> 

Desmoda™ (desmopressin acetate) Oral Solution - formerly ET-600 – New Drug Approval – February 25, 2026 - Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced the U.S. Food and Drug Administration (FDA) approval of a New Drug Application (NDA) for Desmoda™ (desmopressin acetate) Oral Solution for the management of central diabetes insipidus, also known as arginine vasopressin deficiency (AVP-D), as antidiuretic replacement therapy for patients of all ages. <Read More> 

Loargys® (pegzilarginase-nbln) Injection – New Drug Approval – February 23, 2026 - Immedica Pharma announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Loargys® (pegzilarginase-nbln), an arginine specific enzyme indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction. <Read More> 

Bysanti™ (milsaperidone) Tablets – New Drug Approval – February 20, 2026 - Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced that the U.S. Food and Drug Administration (FDA) has approved Bysanti™ (milsaperidone) tablets, a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. <Read More> 

New Label Expansions

Eylea HD® (aflibercept) Injection – New Label Expansion – New Dosage Regimen: April 2, 2026 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved the extension of dosing intervals for Eylea HD® (aflibercept) up to every 20 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) following one year of successful response based on visual and anatomic outcomes. As part of the approval, the FDA has updated the Eylea HD® label to include 96-week (2-year) data from the pivotal PULSAR trial in wAMD and the pivotal PHOTON trial in DME, demonstrating sustained efficacy and safety through 2 years with extended dosing intervals. <Read More> 

Tecartus® (brexucabtagene autoleucel) Suspension for Intravenous Infusion – New Label Expansion – Labeling Revision Approved: April 1, 2026 - The U.S. Food and Drug Administration (FDA) has granted traditional (full) approval to Kite’s CAR T-cell therapy, Tecartus® (brexucabtagene autoleucel), for adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). The full approval now includes efficacy, safety and pharmacokinetic data from Cohort 3 of the ZUMA-2 study in patients who are R/R after one or more lines of therapy and who are Bruton tyrosine kinase inhibitor (BTKi)-naïve. <Read More> 

Spinraza® (nusinersen) Injection – New Label Expansion – New Dosage Regimen: March 27, 2026 - Biogen Inc. (Nasdaq: BIIB) announced that the High Dose Regimen of Spinraza® (nusinersen), which is comprised of 50 mg/5 mL and 28 mg/5 mL doses, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of spinal muscular atrophy (SMA). Backed by more than 10 years of clinical data supporting the Low Dose Regimen of Spinraza® (12 mg), High Dose Spinraza® was designed to deliver a higher concentration of drug through both the loading and maintenance dosing phases, to provide a new option in response to the ongoing needs of the community. <Read More>  

Alyftrek® (deutivacaftor, tezacaftor and vanzacaftor) – New Label Expansion – Labeling Revision Approved: March 27, 2026 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced the U.S. Food and Drug Administration (FDA) has approved expanded use of Alyftrek® (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of people with cystic fibrosis (CF) ages 6 and older with a variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. Additionally, the U.S. FDA has also expanded the indication statement for Trikafta® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 2 and older. <Read More> 

neffy® (epinephrine) Nasal Spray – New Label Expansion – Labeling Revision Approved: March 26, 2026 - ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, announced that the U.S. Food and Drug Administration (FDA) has approved updating the neffy® 1 mg (epinephrine nasal spray) prescribing information to remove the age criteria so all children and adults who weigh 33 lbs. or more can utilize neffy® for the emergency treatment of Type 1 allergic reactions, including anaphylaxis. Prior to the update, pediatric patients needed to meet a weight requirement and be at least four years of age. <Read More>  

Adstiladrin® (nadofaragene firadenovec-vncg) Suspension for Intravesical Use – New Label Expansion – Labeling Revision Approved: March 23, 2026 - Ferring Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Adstiladrin® (nadofaragene firadenovec-vncg), enabling an accelerated water-bath thawing method, completed in about 25 minutes, to enhance efficient clinical preparation for healthcare teams. <Read More> 

Opdivo® (nivolumab) Injection – New Label Expansion – New Indication Approved: March 20, 2026 - Bristol Myers Squibb (NYSE: BMY) announced that Opdivo® (nivolumab) has received approval for two new classical Hodgkin Lymphoma (cHL) indications in the U.S. and the European Union (EU). The U.S. Food and Drug Administration (FDA) granted approval of Opdivo® in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV cHL. <Read More> 

Imcivree® (setmelanotide) Injection – New Label Expansion – New Indication Approved: March 19, 2026 - Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for Imcivreeâ (setmelanotide) seeking approval for the treatment of conditions associated with acquired hypothalamic obesity. <Read More> 

Wegovy® (semaglutide) Injection and Tablets – New Label Expansion – New Dosage Form Approved: March 19, 2026 - The U.S. Food and Drug Administration approved a new higher dose (7.2 mg) of Wegovy® (semaglutide) injection, called Wegovy® HD, for weight loss and long-term maintenance of weight loss for certain adult patients. The decision was granted just 54 days after filing and represented the fourth approval under the Commissioner’s National Priority Voucher (CNPV) pilot program. <Read More>  

Cosentyx® (secukinumab) Injection – New Label Expansion – Patient Population Altered: March 13, 2026 - Novartis announced that Cosentyx® (secukinumab) received US Food and Drug Administration (FDA) approval for treating pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS), making it the only IL-17A inhibitor for this population. The approval of a distinct biologic option for pediatric patients living with HS allows treatment to be tailored to the individual and establishes Cosentyx® as a meaningful addition to the treatment landscape. <Read More> 

Arexvy™ (respiratory syncytial virus vaccine, adjuvanted) Suspension for Intramuscular Injection – New Label Expansion – Patient Population Altered: March 12, 2026 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has expanded the approved age indication of Arexvy™ (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV. Arexvy™ was previously approved in the US for the prevention of RSV-related LRTD in adults aged 60 and older, and adults aged 50–59 at increased risk for LRTD caused by RSV. This vaccine is not for use in pregnant individuals. <Read More> 

Wellcovorin™ (leucovorin calcium) Tablets – New Label Expansion – New Indication Approved: March 9, 2026 - The U.S. Food and Drug Administration approved expanded use of Wellcovorin™ (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1). <Read More> 

Pylarify™ (piflufolastat F 18) Injection – New Label Expansion – New Formulation Approved: March 6, 2026 - Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced that the U.S. Food and Drug Administration (FDA) has approved Pylarify TruVu™ (piflufolastat F 18) injection, a new formulation of its F 18 prostate-specific membrane antigen (PSMA) imaging agent. Pylarify TruVu™ is indicated for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. <Read More>

Sotyktu® (deucravacitinib) Tablets – New Label Expansion – New Indication Approved: March 6, 2026 - Bristol Myers Squibb (NYSE:BMY) announced that the U.S. Food and Drug Administration (FDA) has approved Sotyktu® (deucravacitinib) for the treatment of adults with active psoriatic arthritis (PsA). Sotyktu®, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, is the first TYK2 inhibitor to be approved for PsA. <Read More> 

Tecvayli® (teclistamab-cqyv) Injection – New Label Expansion – New Indication Approved: March 5, 2026 - Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, announced that the U.S. Food and Drug Administration (FDA) approved Tecvayli® (teclistamab-cqyv) plus Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. <Read More> 

Palynziq® (pegvaliase-pqpz) Injection – New Label Expansion – Patient Population Altered: February 27, 2026 - BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for Palynziq® (pegvaliase-pqpz) to include pediatric patients 12 years of age and older with phenylketonuria (PKU). Palynziq® is the only enzyme substitution therapy approved to reduce blood phenylalanine (Phe) concentrations in people with PKU. <Read More>  

Sogroya® (somapacitan-beco) Injection – New Label Expansion – Patient Population Altered: February 27, 2026 - Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved three new indications for once-weekly Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg, a long-acting growth hormone. Sogroya® is now indicated for children aged 2.5 years and older with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome (NS). Sogroya® is also indicated for children aged 2.5 years and older and adults with growth hormone deficiency (GHD). <Read More> 

Hernexeos® (zongertinib) Tablets – New Label Expansion – New Indication Approved: February 26, 2026 - The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim’s Hernexeos® (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. This indication is approved under accelerated approval based on objective response rate and duration of response. <Read More> 

Juxtapid® (lomitapide) Capsules – New Label Expansion – Patient Population Altered: February 25, 2026 - Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Juxtapid® (lomitapide) capsules for pediatric use in homozygous familial hypercholesterolemia (HoFH) for children 2 years of age and older. Juxtapid® is a proven therapy that has been approved in the United States for adult patients with HoFH to be used along with diet and other lipid-lowering treatments, since 2012. <Read More> 

Braftovi® (encorafenib) Capsules – New Label Expansion – New Indication Approved: February 24, 2026 - Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Braftovi® (encorafenib) in combination with cetuximab (marketed as Erbitux®) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation based on results from the global Phase 3 BREAKWATER trial. <Read More>  

Dupixent® (dupilumab) Injection – New Label Expansion – New Indication Approved: February 23, 2026 - The US Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. The FDA evaluated Dupixent® under priority review for the treatment of AFRS, which is reserved for medicines that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. This approval expands our approved indications in sino-nasal diseases to now include AFRS, alongside chronic rhinosinusitis with nasal polyps. <Read More> 

Elucirem™ (gadopiclenol) Injection – New Label Expansion – Patient Population Altered: February 20, 2026 - Guerbet, a global specialist in contrast media and solutions for medical imaging, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved a labeling update for Elucirem™ (gadopiclenol) injection. The new indication includes approval for pediatric patients aged 0-2 years (including term neonates) for its macrocyclic high-relaxivity gadolinium-based contrast agent. <Read More>  

Calquence® (acalabrutinib) Capsules and Tablets – New Label Expansion – New Indication Approved: February 19, 2026 - AstraZeneca’s Calquence® (acalabrutinib) in combination with venetoclax has been approved in the US as the first all-oral, fixed-duration regimen for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The approval by the US Food and Drug Administration (FDA) was based on positive results from the AMPLIFY Phase III trial, which were presented at the American Society of Hematology 2024 Annual Meeting and published in The New England Journal of Medicine. <Read More> 

Wakix® (pitolisant) Tablets – New Label Expansion – Patient Population Altered: February 13, 2026 - Harmony Biosciences (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for Wakix® (pitolisant) tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. Wakix® is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult narcolepsy patients with or without cataplexy. <Read More> 

Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) Injection – New Label Expansion – New Dosage Regimen: February 13, 2026 - Johnson & Johnson (NYSE: JNJ) announced the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule for Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj). When administered in combination with oral Lazcluze® (lazertinib) for the first-line treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC), monthly dosing delivers consistent outcomes with the previously approved bi-weekly subcutaneous (SC) dosing schedule. <Read More> 

Enzeevu® (aflibercept-abzv) Injection – New Label Expansion – New Indication Approved: February 12, 2026 - Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, announced that the US Food and Drug Administration (FDA) has approved an expanded label for Enzeevu® (aflibercept-abzv), to include multiple retinal indications. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – New Indication Approved: February 10, 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) plus paclitaxel, with or without bevacizumab, for the treatment of adults with PD-L1+ (Combined Positive Score [CPS] ≥1), as determined by an FDA-authorized test, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received one or two prior systemic treatment regimens. <Read More>  

Yescarta® (axicabtagene ciloleucel) Suspension for Intravenous Infusion – New Label Expansion – Labeling Revision Approved: February 5, 2026 - Kite, a Gilead Company (Nasdaq: GILD), announced the U.S. Food and Drug Administration (FDA) approved an update to the Yescarta® (axicabtagene ciloleucel) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL).

Ozempic® (semaglutide) Injection and Tablets – New Label Expansion – Labeling Revision Approved: January 30, 2026 – Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Ozempic® (semaglutide) tablets 1.5 mg, 4 mg, and 9 mg as the name for oral semaglutide 1.5 mg, 4 mg, and 9 mg. The active ingredient remains the same semaglutide molecule, and the Ozempic® pill is FDA-approved for use in adults with type 2 diabetes to improve blood sugar along with diet and exercise, and to reduce the risk of major adverse cardiovascular events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes who are at high risk for these events. <Read More> 

New Drug Shortage

April 10, 2026

April 09, 2026

April 08, 2026

April 07, 2026

April 06, 2026

Updated Drug Shortage

April 10, 2026

April 09, 2026

April 08, 2026

April 07, 2026

April 06, 2026

New Drug Recall and Safety Alerts

Wound Care Gel Products by Blaine Labs, Inc - New Voluntary Recall – April 8, 2026 - Blaine Labs, Inc. is voluntarily recalling three (3) lot numbers of Wound Care Gel products, 1 oz. & 3 oz. (0.1% Benzalkonium Chloride) to the consumer level due to microbial contamination. The affected product has been found to contain Lysinibacillus fusiformis, an environmental organism. <Read More> 

Magnesium Sulfate in Water for Injection, USP 4 g/100mL (NDC 70121-1720-3) by Amneal Pharmaceuticals LLC – New Voluntary Recall – March 24, 2026 - Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag, to the hospital level. A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL. <Read More> 

Webcol™ Large Alcohol Prep Pad by Cardinal Health – New Voluntary Recall – March 19, 2026 - Cardinal Health has issued a voluntary recall for select lots of Webcol™ Large Alcohol Prep Pads (70% isopropyl alcohol) to the consumer level. The product is being recalled due to microbial contamination identified as Paenibacillus phoenicis. <Read More> 

New Generic/Biosimilar Approval and Launch

Ponlimsi™ (denosumab-adet) Injection – New Prolia® Biosimilar Approval – March 27, 2026 - Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced milestones in its biosimilar portfolio, demonstrating continued momentum in the advancement of its Pivot to Growth strategy. The United States (U.S.) Food and Drug Administration (FDA) has approved Ponlimsiä (denosumab-adet) as a biosimilar to Prolia®. <Read More> 

Clinical and Pharmacy News

Questioning the Prescription: Antidepressants and the Medicalization of Childhood – April 10, 2026 – This week Mad in America explores four recently published articles related to antidepressant use in children and adolescents. The first reports that although clinical trials have found little efficacy for the use of fluoxetine (Prozac®) as a treatment for depression in children, clinical guidelines still recommend it. The second finds that persistent antidepressant use is common and rising in Australian children… <Read More> 

Under the Magnifying Glass: A Wave of Drug Price Transparency – April 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). <Read More> 

How Hospital Pharmacies Can Access Restrictive Specialty Networks – March 2, 2026 - As payors and pharmacy benefit managers (PBMs) narrow specialty pharmacy networks, health system pharmacies face increasing exclusion from dispensing high-cost therapies to their own patients. For many organizations, accessing these restrictive networks has become both a strategic imperative and an operational challenge. Signature Healthcare, a regional health system in southern Massachusetts, addressed this challenge by partnering with Clearway Health, a specialty pharmacy services organization that originated from Boston Medical Center Health System. Clearway Health now collaborates with hospitals nationwide to improve access to care for patients requiring complex, high-cost medications. <Read More> 

As Rare Disease Drug Approvals Accelerate, Survey Highlights Gaps in Care Coordination – March 2, 2026 - As the pipeline for rare disease therapies continues to expand, new survey data suggest that the healthcare system is not keeping pace with the coordination demands required to deliver those treatments effectively. A national survey commissioned by PANTHERx Rare and conducted by Morning Consult found that patients, caregivers, and healthcare professionals perceive wide gaps in rare disease care delivery, whereas payors view care coordination far more favorably. Among patients and caregivers, 76% rated the current rare disease care system as average, below average, or poor, with 44% describing it as poor. Healthcare professionals were even more critical: 86% rated the system as average or worse, and 50% described it as poor. In contrast, a majority of payors (58%) rated the system as good, revealing what the report describes as a stakeholder disconnect. <Read More> 

Pharmacist Welcomes Bill Restricting Pharmacy Benefit Managers; CVS Projects Mass Closures – February 25, 2026 - Tennessee’s Senate Health and Welfare Committee considered a bill to place restrictions on pharmacy benefit managers (PBMs) on Wednesday. According to the American Medical Association, a pharmacy benefit manager is a middleman in the prescription drug supply chain. They manage prescription drug plan benefits for insurers and employers. PBMs negotiate rebates and discounts, put together networks, and conduct management tasks. Sen. Bobby Harshbarger (R-Kingsport), a pharmacist himself, proposed the bill known as the Fair Rx Act. Christian Tate, a pharmacist at Berry’s Pharmacy in Kingsport, said independent pharmacists just want an equal playing field, and the bill would be a step in the right direction. <Read More> 

Bridging the Gap in Biosimilar Use and Uptake in Inflammatory Conditions – February 24, 2026 - Within the last 5 years, the FDA has approved several key biosimilars for inflammatory conditions such as inflammatory bowel disease and rheumatologic disorders. Infliximab biosimilars entered the market in 2016 as IV infusions only and are billed through the medical benefit. In 2023 and 2025, adalimumab and ustekinumab biosimilars were approved, respectively. Adalimumab has 10 biosimilars, and ustekinumab has 7 on the market. Given that self-administered adalimumab and ustekinumab are billed through the pharmacy benefit, they introduce a new set of challenges and opportunities. This article addresses barriers that arise for the prescribing provider and team, including specialty pharmacists who manage biologic access in collaboration with the clinic, and provides recommendations for future biosimilar utilization. <Read More> 

ACC, AHA Release First-Ever Guideline for Treatment and Management of Acute PE – February 19, 2026 - The new “ACC/AHA Guideline for the Evaluation and Management of Acute Pulmonary Embolism (PE) in Adults” is a de novo document offering comprehensive, evidence‑based recommendations for the evaluation, management and follow‑up of adults with acute PE. Collaborated on and endorsed by an additional eight societies, the new guideline recognizes that management of patients with acute PE "is uniquely multidisciplinary and crosses emergency department, inpatient settings and outpatient clinics." <Read More> 

House Members Push for PBM Changes, Question Trump Drug Plan – February 11, 2026 - Lawmakers from both sides of the aisle on Wednesday came down hard on various sectors of the U.S. prescription drug supply chain during a hearing to shed light on the reasons for rising costs. At a House Energy and Commerce Health Subcommittee hearing, Rep. Brett Guthrie, R-Ky., touted changes in the fiscal 2026 spending package enacted this month to improve pharmacy-benefit manager pricing transparency and reduce incentives for PBMs to promote higher-priced drugs to Medicare Part D beneficiaries. But Guthrie stressed that further changes could be forthcoming. “Historic PBM reform is just the beginning,” said Guthrie, who chairs the full Energy and Commerce panel. “More needs to be done throughout the drug supply chain to improve affordability.” <Read More> 

340B in the News

AbbVie Challenges 'Outdated' 340B Drug Discount Program Guidance in New Lawsuit – April 9, 2026 - AbbVie is spearheading a new battle in pharma’s long-running fight to reform the federal government’s 340B drug discount program with a lawsuit that challenges the definition of what it means to be a “patient” under the program's framework. AbbVie, a three-decade participant in the 340B system, leveled the suit to “restore integrity” to the drug discount program, the company explained in its 72-page complaint against the Department of Health and Human Services (HHS) and its secretary Robert F. Kennedy Jr., plus the Department of Health Resources and Services Administration (HRSA) and administrator Thomas Engels. <Read More> 

Updates to 340B and What Pharmacists Need to Know – March 26, 2026 - The 340B Drug Pricing Program is a federally mandated drug pricing program created by Congress in 1992 that allows certain health care organizations (called covered entities) to purchase specific outpatient drugs at significantly discounted prices. The core intent is to help these providers “stretch scarce resources” so they can serve low-income and underserved patients, reach more patients, and provide more comprehensive services in their communities. However, despite its original intent, the program faces various challenges in the shape of manufacturer restrictions, legal and regulatory uncertainty, administrative burdens, and compliance risks. As restrictions, litigation, and reimbursement cuts stack up, 340B savings shrink. <Read More> 

Association Between 340B Contract Pharmacy Growth and Payer-Specific Drug Coverage – February 27, 2026 - The 340B Drug Pricing Program entitles participating hospitals and clinics (called covered entities) to purchase outpatient drugs at a substantial discount from manufacturers. Covered entities either distribute 340B drugs at reduced prices to patients or generate a subsidy by charging insured patients market prices for discounted drugs. Drugs purchased through 340B accounted for $66 billion in 2023, with approximately one-fifth of this sum coming from sales through unaffiliated community retail pharmacies, called contract pharmacies. We linked data on contract pharmacy locations to Managed Market Surveyor data to describe the markets in which 340B covered entities locate contract pharmacies. <Read More> 

Report Questions Drug Pricing as Supporters Defend 340B Program – February 19, 2026 - Hospitals and clinics in Michigan participating in a federal drug discount program are marking up medications and shifting costs onto public employee health plans, according to a new analysis. The report from IQVIA, a health data analytics and research company, found that providers participating in the federal 340B Drug Pricing Program are buying medications at steep discounts and billing insurers at much higher rates – increasing costs for both state health plans and taxpayers. <Read More> 

Trump Administration Restarts its Efforts to Pilot 340B Rebates – February 13, 2026 – Only a week after calling it quits on a court-halted pilot program, the Trump administration is already revving the engine on how it could test out a rebate model for the 340B Drug Discount program. The Health Resources and Services Administration (HRSA) released a request for information (RFI) asking stakeholders and the public for input on whether and how such a model should be implemented for 340B, which, for over 30 years, has required drug manufacturers to provide upfront discounts on their products to help subsidize safety-net care. <Read More> 

Following Legal Setbacks, HHS Agrees to Toss 340B Rebate Model Pilot Program – February 6, 2026 - The Department of Health and Human Services has officially backed down on its halted 340B Rebate Model Pilot Program, telling the courts this week that it plans to pull relevant notices and application approvals. Lawyers for the government and plaintiffs who sued to block the program—several hospitals and hospital groups including American Hospital Association (AHA)—filed Thursday afternoon in the U.S. District Court for the District of Maine a joint motion for vacatur and remand. <Read More> 

Site-of-Care Shift for Physician-Administered Drug Therapies: 2026 Update – January 2026 - Using new Medicare data, this paper updates a prior analysis1 evaluating the site of care for all Medicare Part B drug therapies and finds that previously observed trends are continuing. Specifically, 340B Drug Pricing Program hospital outpatient departments (HOPDs)—including both HOPDs at the hospital itself and off-campus locations—continue to represent a growing share of outpatient drug administrations. This analysis also examines how these trends are reflected in top drugs used to treat breast cancer, rheumatoid arthritis, and multiple myeloma. <Read More> 

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Clinical Insights: February 6th, 2026

New Drug/Vaccine Approval

Yuvezzi™ (brimonidine tartrate and carbachol) Ophthalmic Solution - formerly Brimochol PF™ – New Drug Approval – January 28, 2026 – Tenpoint Therapeutics, Ltd., a global, commercial biotechnology company focused on developing groundbreaking treatments to improve vision in the aging eye, announced that the U.S. Food and Drug Administration (FDA) approved Yuvezzi™ (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as Brimochol PF™, the first and only dual-agent eye drop for the treatment of presbyopia in adults. <Read More> 

Zycubo™ (copper histidinate) Injection - formerly CUTX-101 – New Drug Approval – January 12, 2026 - The U.S. Food and Drug Administration approved the Zycubo™ (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients. “With today’s action, children with this devastating, degenerative disease will have an FDA-approved treatment option and the potential to live longer,” said Christine Nguyen, M.D., Deputy Director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “The FDA will continue to work with the rare disease community to advance drug development for patients with Menkes disease and other rare conditions.” <Read More>  

New Label Expansions

Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection – New Label Expansion – January 27, 2026 – Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of transplant eligibility. <Read More> 

Afrezza® (insulin human [rDNA origin]) Inhalation Powder - New Label Expansion – January 23, 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 an update to the Prescribing Information for Afrezza® (insulin human) Inhalation Powder, revising recommendations for the starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens. <Read More>  

Nexplanon® (etonogestrel) Implant - New Label Expansion – January 16, 2026 - Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Nexplanon® (etonogestrel implant), which is indicated for use by women of reproductive potential to prevent pregnancy. The sNDA extends the duration of use of Nexplanon® for up to five years, an extension of the previous three-year indication. <Read More>  

New Drug Shortage

January 30, 2026

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January 20, 2026

January 13, 2026

Updated Drug Shortage

February 02, 2026

January 27, 2026

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January 22, 2026

January 21, 2026

New Drug Recall and Safety Alerts

No new update.

Clinical and Pharmacy News

Prior Authorization Ranked Top Barrier to Health Care Access After Cost – February 2, 2026 – While the cost of health care remains the dominant worry among Americans, the process of obtaining prior authorization from insurers has become the most burdensome noncost barrier for insured adults trying to access care, according to a new KFF Health Tracking Poll released today. The findings underscore growing public frustration with insurance-driven obstacles that can delay, alter, or even block necessary medical services, treatments, and medications. <Read More>  

Why Pharmacy Transparency is Becoming a C-Suite Issue – January 29, 2026 – The U.S. healthcare industry is entering a pivotal moment in its debate over pharmacy benefit transparency, and HR executives—especially those overseeing self-insured health plans—are increasingly at the center of it. In Congress, lawmakers have introduced legislation aimed at improving visibility into how pharmacy benefit managers (PBMs) operate and how prescription drug prices are set, while a growing number of lawsuits challenge opaque pricing practices, rebate arrangements and whether plan sponsors exercised appropriate oversight. Public scrutiny is rising as well, with high-profile business figures like Mark Cuban using conference stages, media interviews and social channels to urge employers to demand greater transparency (an argument that aligns with his business interest in reshaping how prescription drugs are priced and purchased). And that pressure has reached PBMs themselves: As of 2025, the CEOs of the three largest PBMs have all publicly stated that rebates would be returned to customers. <Read More>

US Labor Department Proposes Rule to Boost Transparency in Pharmacy Benefit Manager Fees – January 29, 2026 - The U.S. Department of Labor's Employee Benefits Security Administration on Thursday issued a proposed rule aimed at increasing transparency around fees and compensation collected by pharmacy benefit managers. The move, which follows a directive under President Donald Trump's executive order on lowering drug prices, seeks to clarify PBM business practices that affect employer-sponsored health plans covering millions of Americans. <Read More> 

US Vaccine Guideline Changes Challenge Clinical Practice, Insurance Coverage – January 27, 2026 – Recent changes to routine vaccine recommendations have created confusion and uncertainty regarding public health guidance. These changes may limit or restrict access to certain vaccines due to a lack of availability or insurance coverage, which could increase costs. Clinicians are advised to provide opportunities to discuss the underlying scientific evidence supporting recommended vaccines. The American Academy of Pediatrics (AAP) no longer endorses the immunization schedule from the Centers for Disease Control and Prevention (CDC) and strongly recommends the full set of immunizations. <Read More> 

New Guideline Expands Stroke Treatment for Adults, Offers First Pediatric Stroke Guidance – January 26, 2026 – Expanded eligibility for advanced stroke therapies and new recommendations for diagnosing and treating stroke in children and adults are among the major updates in the new 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke from the American Stroke Association, a division of the American Heart Association, published in the Association’s flagship journal Stroke. <Read More>

New Clinical Practice Guideline Recognizes Insomnia and Sleep Apnea Can Occur Together – January 22, 2026 – Getting regular restorative sleep on a regular basis is essential to good health — yet studies have shown that lack of sleep has left the military less combat ready. To address this urgent issue, the Department of Defense and the Department of Veterans Affairs revised the Clinical Practice Guideline for the Management of Chronic Insomnia Disorder and Obstructive Sleep on July 29, 2025. The lack of restorative sleep is known as chronic insomnia disorder. Obstructive sleep apnea is characterized by repetitive snoring, choking, and awakenings. These two conditions often go together, resulting in sleepiness that affects service member duty performance and overall readiness, and can lead to serious physical and mental health consequences. <Read More>

How Specialty Pharmacists Can Keep HIV Patients on ART – January 21, 2026 – A team of specialty pharmacists and pharmacy liaisons in Brooklyn successfully transitioned a small group of patients living with HIV from daily oral antiviral therapy (ART) to injectable long-acting antiretroviral therapy (LA-ART). The switch improved medication access and adherence, and optimized treatment outcomes for HIV management and PrEP, the team reported at the NASP 2025 Annual Meeting & Expo, in Denver (poster OPR17-OR). Treatment shortcomings of oral ART, according to the poster, include daily pill fatigue, social stigma, and inconsistent access to medication. <Read More>

FDA Schedules Review Meeting After Gene Therapy Shows Slowing of Huntington’s Progression – January 13, 2026 – The FDA has scheduled a Type A meeting with uniQure to discuss materials supporting a potential accelerated approval pathway for AMT-130, the company’s investigational gene therapy for Huntington’s disease, reopening regulatory engagement after a setback in late 2025. In an announcement on Jan. 9, 2026, uniQure said the meeting will focus on its data supporting accelerated approval of AMT-130. The company said it expects to issue a further update after receiving official minutes. <Read More> 

340B in the News

A Win for Kids — And Why 340B Still Needs Defending – January 27, 2026 – Protecting the 340B Drug Pricing Program remains a top priority for the Children’s Hospital Association, and recent developments underscore the importance of our advocacy. Working closely with our member hospitals, we have taken action to safeguard 340B and the children’s hospitals that rely on it. Our efforts helped halt a pilot rebate program that would fundamentally alter how 340B operates and place an unsustainable financial burden on children’s hospitals. In January, a federal appeals court paused the proposed rebate program that would provide money back to hospitals after drugs were purchased. The administration dropped an appeal of the courts’ decision, allowing upfront discounts to continue. With the pilot rebate program now on an indefinite pause, CHA is building on that momentum to continue protecting this vital program. <Read More> 

Government Withdraws Appeal in 340B Rebate Pilot Program Litigation, Signaling Shift – January 27, 2026 – The recent litigation concerning the government’s 340B Rebate Model Pilot Program (the Rebate Program), as further described below, took an unexpected turn as the federal government recently signaled that it intended to revise its approach to the Rebate Program. This change in strategy was previewed by the government in a letter filed with the Court on January 12, 2026—the deadline for briefing regarding the preliminary injunction—stating that the government was considering “returning the approvals challenged [in the lawsuit] to [the Health Resources and Services Administration] for reconsideration,” and that the parties “plan to dismiss the appeal in short order.” The government formally moved to dismiss its appeal on January 16, 2026, and the First Circuit dismissed the appeal on January 20, 2026. <Read More>

AHA Urges HRSA to Stop Eli Lilly’s 340B Claims-Data Submission Policy from Going Into Effect  – January 26, 2026 – The urged the Health Resources and Services Administration to take immediate action to stop a new Eli Lilly and Company policy from taking effect on Feb. 1, including by “assessing civil monetary penalties for intentionally overcharging 340B hospitals.” On Jan. 15, Lilly issued a notice to all 340B covered entities that the company was updating its data requirements for its 340B distribution program. The policy would require 340B covered entities to submit claims data for all dispensations of all Lilly drugs, regardless of setting. <Read More> 

HRSA Announces 340B Rebate Model Pilot Program – January 23, 2026 – On August 1, 2025, the Health Resources and Services Administration (HRSA) released a federal register notice announcing its long-anticipated 340B rebate model guidance, which implements a relatively narrow pilot program focusing on drugs subject to Medicare drug price negotiations for 2026. While the pilot program is voluntary for manufacturers, covered entities will need to submit the required data to access the 340B price via rebate on selected drugs under approved manufacturer plans. The notice states the pilot model is intended to address the 340B and Inflation Reduction Act (IRA) maximum fair price (MFP) deduplication. The model requirements mention that rebates should not be denied based on compliance concerns with diversion or Medicaid duplicate discounts. <Read More> 


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Clinical Insights: February 6th, 2026

New Drug/Vaccine Approval

Yuvezzi™ (brimonidine tartrate and carbachol) Ophthalmic Solution - formerly Brimochol PF™ – New Drug Approval – January 28, 2026 – Tenpoint Therapeutics, Ltd., a global, commercial biotechnology company focused on developing groundbreaking treatments to improve vision in the aging eye, announced that the U.S. Food and Drug Administration (FDA) approved Yuvezzi™ (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as Brimochol PF™, the first and only dual-agent eye drop for the treatment of presbyopia in adults. <Read More> 

Zycubo™ (copper histidinate) Injection - formerly CUTX-101 – New Drug Approval – January 12, 2026 - The U.S. Food and Drug Administration approved the Zycubo™ (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients. “With today’s action, children with this devastating, degenerative disease will have an FDA-approved treatment option and the potential to live longer,” said Christine Nguyen, M.D., Deputy Director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “The FDA will continue to work with the rare disease community to advance drug development for patients with Menkes disease and other rare conditions.” <Read More>  

New Label Expansions

Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection – New Label Expansion – January 27, 2026 – Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of transplant eligibility. <Read More> 

Afrezza® (insulin human [rDNA origin]) Inhalation Powder - New Label Expansion – January 23, 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 an update to the Prescribing Information for Afrezza® (insulin human) Inhalation Powder, revising recommendations for the starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens. <Read More>  

Nexplanon® (etonogestrel) Implant - New Label Expansion – January 16, 2026 - Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Nexplanon® (etonogestrel implant), which is indicated for use by women of reproductive potential to prevent pregnancy. The sNDA extends the duration of use of Nexplanon® for up to five years, an extension of the previous three-year indication. <Read More>  

New Drug Shortage

January 30, 2026

January 28, 2026

January 27, 2026

January 20, 2026

January 13, 2026

Updated Drug Shortage

February 02, 2026

January 27, 2026

January 23, 2026

January 22, 2026

January 21, 2026

New Drug Recall and Safety Alerts

No new update.

Clinical and Pharmacy News

Prior Authorization Ranked Top Barrier to Health Care Access After Cost – February 2, 2026 – While the cost of health care remains the dominant worry among Americans, the process of obtaining prior authorization from insurers has become the most burdensome noncost barrier for insured adults trying to access care, according to a new KFF Health Tracking Poll released today. The findings underscore growing public frustration with insurance-driven obstacles that can delay, alter, or even block necessary medical services, treatments, and medications. <Read More>  

Why Pharmacy Transparency is Becoming a C-Suite Issue – January 29, 2026 – The U.S. healthcare industry is entering a pivotal moment in its debate over pharmacy benefit transparency, and HR executives—especially those overseeing self-insured health plans—are increasingly at the center of it. In Congress, lawmakers have introduced legislation aimed at improving visibility into how pharmacy benefit managers (PBMs) operate and how prescription drug prices are set, while a growing number of lawsuits challenge opaque pricing practices, rebate arrangements and whether plan sponsors exercised appropriate oversight. Public scrutiny is rising as well, with high-profile business figures like Mark Cuban using conference stages, media interviews and social channels to urge employers to demand greater transparency (an argument that aligns with his business interest in reshaping how prescription drugs are priced and purchased). And that pressure has reached PBMs themselves: As of 2025, the CEOs of the three largest PBMs have all publicly stated that rebates would be returned to customers. <Read More>

US Labor Department Proposes Rule to Boost Transparency in Pharmacy Benefit Manager Fees – January 29, 2026 - The U.S. Department of Labor's Employee Benefits Security Administration on Thursday issued a proposed rule aimed at increasing transparency around fees and compensation collected by pharmacy benefit managers. The move, which follows a directive under President Donald Trump's executive order on lowering drug prices, seeks to clarify PBM business practices that affect employer-sponsored health plans covering millions of Americans. <Read More> 

US Vaccine Guideline Changes Challenge Clinical Practice, Insurance Coverage – January 27, 2026 – Recent changes to routine vaccine recommendations have created confusion and uncertainty regarding public health guidance. These changes may limit or restrict access to certain vaccines due to a lack of availability or insurance coverage, which could increase costs. Clinicians are advised to provide opportunities to discuss the underlying scientific evidence supporting recommended vaccines. The American Academy of Pediatrics (AAP) no longer endorses the immunization schedule from the Centers for Disease Control and Prevention (CDC) and strongly recommends the full set of immunizations. <Read More> 

New Guideline Expands Stroke Treatment for Adults, Offers First Pediatric Stroke Guidance – January 26, 2026 – Expanded eligibility for advanced stroke therapies and new recommendations for diagnosing and treating stroke in children and adults are among the major updates in the new 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke from the American Stroke Association, a division of the American Heart Association, published in the Association’s flagship journal Stroke. <Read More>

New Clinical Practice Guideline Recognizes Insomnia and Sleep Apnea Can Occur Together – January 22, 2026 – Getting regular restorative sleep on a regular basis is essential to good health — yet studies have shown that lack of sleep has left the military less combat ready. To address this urgent issue, the Department of Defense and the Department of Veterans Affairs revised the Clinical Practice Guideline for the Management of Chronic Insomnia Disorder and Obstructive Sleep on July 29, 2025. The lack of restorative sleep is known as chronic insomnia disorder. Obstructive sleep apnea is characterized by repetitive snoring, choking, and awakenings. These two conditions often go together, resulting in sleepiness that affects service member duty performance and overall readiness, and can lead to serious physical and mental health consequences. <Read More>

How Specialty Pharmacists Can Keep HIV Patients on ART – January 21, 2026 – A team of specialty pharmacists and pharmacy liaisons in Brooklyn successfully transitioned a small group of patients living with HIV from daily oral antiviral therapy (ART) to injectable long-acting antiretroviral therapy (LA-ART). The switch improved medication access and adherence, and optimized treatment outcomes for HIV management and PrEP, the team reported at the NASP 2025 Annual Meeting & Expo, in Denver (poster OPR17-OR). Treatment shortcomings of oral ART, according to the poster, include daily pill fatigue, social stigma, and inconsistent access to medication. <Read More>

FDA Schedules Review Meeting After Gene Therapy Shows Slowing of Huntington’s Progression – January 13, 2026 – The FDA has scheduled a Type A meeting with uniQure to discuss materials supporting a potential accelerated approval pathway for AMT-130, the company’s investigational gene therapy for Huntington’s disease, reopening regulatory engagement after a setback in late 2025. In an announcement on Jan. 9, 2026, uniQure said the meeting will focus on its data supporting accelerated approval of AMT-130. The company said it expects to issue a further update after receiving official minutes. <Read More> 

340B in the News

A Win for Kids — And Why 340B Still Needs Defending – January 27, 2026 – Protecting the 340B Drug Pricing Program remains a top priority for the Children’s Hospital Association, and recent developments underscore the importance of our advocacy. Working closely with our member hospitals, we have taken action to safeguard 340B and the children’s hospitals that rely on it. Our efforts helped halt a pilot rebate program that would fundamentally alter how 340B operates and place an unsustainable financial burden on children’s hospitals. In January, a federal appeals court paused the proposed rebate program that would provide money back to hospitals after drugs were purchased. The administration dropped an appeal of the courts’ decision, allowing upfront discounts to continue. With the pilot rebate program now on an indefinite pause, CHA is building on that momentum to continue protecting this vital program. <Read More> 

Government Withdraws Appeal in 340B Rebate Pilot Program Litigation, Signaling Shift – January 27, 2026 – The recent litigation concerning the government’s 340B Rebate Model Pilot Program (the Rebate Program), as further described below, took an unexpected turn as the federal government recently signaled that it intended to revise its approach to the Rebate Program. This change in strategy was previewed by the government in a letter filed with the Court on January 12, 2026—the deadline for briefing regarding the preliminary injunction—stating that the government was considering “returning the approvals challenged [in the lawsuit] to [the Health Resources and Services Administration] for reconsideration,” and that the parties “plan to dismiss the appeal in short order.” The government formally moved to dismiss its appeal on January 16, 2026, and the First Circuit dismissed the appeal on January 20, 2026. <Read More>

AHA Urges HRSA to Stop Eli Lilly’s 340B Claims-Data Submission Policy from Going Into Effect  – January 26, 2026 – The urged the Health Resources and Services Administration to take immediate action to stop a new Eli Lilly and Company policy from taking effect on Feb. 1, including by “assessing civil monetary penalties for intentionally overcharging 340B hospitals.” On Jan. 15, Lilly issued a notice to all 340B covered entities that the company was updating its data requirements for its 340B distribution program. The policy would require 340B covered entities to submit claims data for all dispensations of all Lilly drugs, regardless of setting. <Read More> 

HRSA Announces 340B Rebate Model Pilot Program – January 23, 2026 – On August 1, 2025, the Health Resources and Services Administration (HRSA) released a federal register notice announcing its long-anticipated 340B rebate model guidance, which implements a relatively narrow pilot program focusing on drugs subject to Medicare drug price negotiations for 2026. While the pilot program is voluntary for manufacturers, covered entities will need to submit the required data to access the 340B price via rebate on selected drugs under approved manufacturer plans. The notice states the pilot model is intended to address the 340B and Inflation Reduction Act (IRA) maximum fair price (MFP) deduplication. The model requirements mention that rebates should not be denied based on compliance concerns with diversion or Medicaid duplicate discounts. <Read More> 


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Ready to get started?

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

Contact Us

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