Clinical Insights: April 3, 2024

New Drug/Vaccine Approval

Atebrioz™ (zilurgisertib) Tablets – New Drug Approval – September 25, 2026 – The U.S. Food and Drug Administration (FDA) has approved Atebrioz™ (zilurgisertib) tablets to reduce the volume of total new heterotopic ossification (bone formation outside the skeleton) in adults and pediatric patients 12 years and older with fibrodysplasia ossificans progressiva (FOP). The recommended starting dosage is 100 mg orally once daily with or without food. <Read More> 

Onswik™ (insulin efsitora alfa-gobe) Injection - New Drug Approval – September 24, 2026 – Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) approval of Onswik™ (insulin efsitora alfa-gobe), a once-weekly basal insulin, indicated along with diet and exercise to control high blood sugar in adults with type 2 diabetes. Onswik™ is designed to deliver steady basal insulin levels over a full seven days. <Read More> 

Lyrfigtu™ (lirafugratinib) Capsules – New Drug Approval – September 23, 2026 – The Food and Drug Administration approved lirafugratinib (Lyrfigtu™, Elevar Therapeutics, Inc.), a kinase inhibitor, for the treatment of adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement. <Read More> 

Fayuvi™ (rebisufligene etisparvovec-hopf) Suspension for Intravenous Infusion - formerly UX111 – New Drug Approval – September 17, 2026 – The U.S. Food and Drug Administration approved Fayuvi™ (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A., MPS IIIA is a rare inherited disease that progressively damages the brain and nervous system, causing children to lose cognitive, language and other developmental abilities over time. Until now, treatment was limited to managing symptoms; there was no FDA-approved therapy designed to change the underlying course of the disease. <Read More> 

Bexlutry™ (lutetium Lu 177 dotatate) Injection – New Drug Approval – September 14, 2026 – Curium™ announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Bexlutry™ lutetium Lu 177 dotatate injection for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. <Read More> 

Pixclara® (floretyrosine F 18) Injection – New Drug Approval – September 11, 2026 – Telix announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Pixclara® (floretyrosine F 18 or 18F-FET), an amino acid positron emission tomography (PET) drug for imaging gliomas (brain cancer). <Read More> 

Isembyld™ (apitegromab-mstn) Injection – New Drug Approval – September 11, 2026 – Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its leading platform in myostatin biology, announced that the FDA has approved Isembyld™ (apitegromab-mstn) for the treatment of spinal muscular atrophy (SMA) in adults and children two years of age and older who are currently receiving a survival motor neuron 2 (SMN2)-targeted treatment. <Read More> 

Etcamah™ (camizestrant) Tablets – New Drug Approval – September 4, 2026 – The Food and Drug Administration granted accelerated approval to camizestrant (Etcamah™, AstraZeneca), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test. <Read More> 

Zanvastro™ (zilganersen) Injection – New Drug Approval – September 3, 2026 – The U.S. Food and Drug Administration has approved Zanvastro™ (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients. Zanvastro™ is the first FDA-approved treatment for Alexander disease and the first therapy to directly target the protein buildup that drives the disease. <Read More>  

Omcazio™ (cabozantinib) Capsules – New Drug Approval – September 3, 2026 – Handa Pharmaceuticals, Inc. (“Handa” or the “Company”) (TSE:6620) announced that the U.S. Food and Drug Administration (“FDA”) has granted final approval to Omcazio™ (cabozantinib) capsules, the lauryl sulfate salt formulation of cabozantinib developed by the Company’s U.S. subsidiary, Handa Oncology, LLC. The action converts Handa’s prior tentative approval to final approval and authorizes Omcazio™ for commercialization in the United States. <Read More>

Mimrylo™ (rusfertide) Lyophilized Powder for Injection – New Drug Approval – August 28, 2026 – Takeda (TSE:4502/NYSE:TAK) announced U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA) for Mimrylo™ (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a blood cancer. <Read More> 

Bixlenvo™ (bictegravir and lenacapavir) Tablets – New Drug Approval – August 27, 2026 – Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo™ (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed. Bixlenvo™ is now the first and only STR option for virologically suppressed people with HIV who are on complex regimens and unable to take currently available STRs. <Read More> 

Lisraya™ (brepocitinib) Tablets – New Drug Approval – August 27, 2026 - The U.S. Food and Drug Administration has approved Lisraya™ (brepocitinib) tablets for the treatment of dermatomyositis in adults. For decades, dermatomyositis patients have had limited treatment options to manage their symptoms. The approval of Lisraya™ offers patients an important new alternative by providing an effective oral treatment option. <Read More> 

Rasonque™ (daraxonrasib) Tablets – New Drug Approval – August 26, 2026 – The U.S. Food and Drug Administration approved Rasonque™ (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer—delivering a new treatment option to patients with advanced pancreatic cancer months ahead of schedule. <Read More> 

New Label Expansions

Welireg® (belzutifan) Tablets – New Expanded Label – September 24, 2026 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai announced the U.S. Food and Drug Administration (FDA) has approved the dual oral regimen of Welireg® (belzutifan), Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, plus Lenvima® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, for the treatment of adult patients with advanced renal cell carcinoma with a clear cell component (ccRCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. <Read More> 

Aqneursa® (levacetylleucine) Granules for Oral Suspension – New Expanded Label – September 18, 2026 – The U.S. Food and Drug Administration has approved Aqneursa® (levacetylleucine) for oral suspension to treat ataxia in adults and pediatric patients with ataxia-telangiectasia weighing at least 15 kg (about 33 pounds). Aqneursa® was previously approved in 2024 to treat the neurological manifestations of Niemann-Pick disease type C. This approval makes Aqneursa® the first treatment approved for ataxia in patients with ataxia-telangiectasia. <Read More> 

Kerendia® (finerenone) Tablets – New Expanded Label – September 17, 2026 – Bayer announced that the U.S. Food and Drug Administration (FDA) approved Kerendia® (finerenone) to reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease in adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D), following the agency’s Priority Review of the supplemental New Drug Application (sNDA). <Read More> 

Ibtrozi® (taletrectinib) Capsules – New Expanded Label – September 16, 2026 – Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Ibtrozi® (taletrectinib), a ROS1 inhibitor approved for the treatment of locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). <Read More> 

Inluriyo® (imlunestrant) Tablets – New Expanded Label – September 16, 2026 – Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Inluriyo® (imlunestrant), an oral estrogen receptor (ER) antagonist, in combination with Verzenio® (abemaciclib), a CDK4/6 inhibitor, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated locally advanced or metastatic breast cancer (MBC), as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

Joenja® (leniolisib) Tablets – New Expanded Label – September 11, 2026 – FDA has approved Joenja® (leniolisib) tablets as the first treatment for activated phosphoinositide 3-kinase delta syndrome (APDS) in children 4-11 years who weigh at least 27 kg. Joenja® was first approved in 2023 for the same indication in patients 12 years and older at a dose of 70 mg orally twice a day. Children 4-11 years take a weight-based dosage (40, 50, or 70 mg) orally twice a day, approximately 12 hours apart. <Read More> 

Imdelltra® (tarlatamab-dlle) for Injection – New Expanded Label – September 11, 2026 – Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) approved an update to the Imdelltra® (tarlatamab-dlle) Prescribing Information that substantially reduces the recommended monitoring time for the first two doses of treatment in an appropriate healthcare setting. This approval means that patients receiving Imdelltra® should now be monitored for 6 to 8 hours from the start of their first two infusions, compared with the previously recommended 22 to 24 hours. <Read More> 

Ameluz® (aminolevulinic acid) Gel – New Expanded Label – September 9, 2026 – Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for Ameluz® (aminolevulinic acid hydrochloride) topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED® lamp series, for the treatment of superficial Basal Cell Carcinoma (sBCC) in adults. <Read More> 

Hyrnuo® (sevabertinib) Tablets – New Expanded Label – September 9, 2026 – The Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo®, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. <Read More> 

Stelara® (ustekinumab) Injection – New Expanded Label – August 28, 2026 – The U.S. Food and Drug Administration has approved Stelara® (ustekinumab) injection for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients aged 2 years old and older. On April 15, 2026, Stelara® was approved for the treatment of moderately to severely active Crohn’s disease (CD) in pediatric patients aged 2 years old and older. Stelara® is the first approved therapeutic monoclonal antibody that does not target human tumor necrosis factor alpha (TNFα) for the two main forms of pediatric inflammatory bowel disease. <Read More> 

Besremi® (ropeginterferon alfa-2b-njft) Injection – New Expanded Label – August 28, 2026 – PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446) announced the U.S. Food and Drug Administration (FDA) has approved Besremi® (ropeginterferon alfa-2b-njft) for the treatment of adults with essential thrombocythemia (ET), making it the first new FDA-approved treatment for ET in nearly three decades. Besremi® has been approved for adults with ET, regardless of their genotype or disease status, including newly diagnosed patients who are naive to cytoreductive therapy. <Read More> 

Spikevax® (COVID-19 Vaccine, mRNA) Injection – New Expanded Label – August 27, 2026 – Moderna, Inc. (NASDAQ:MRNA) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2026-2027 formulas for Spikevax® (COVID-19 Vaccine, mRNA) and mNEXSPIKE® (COVID-19 Vaccine, mRNA), containing the JN.1-lineage XFG subvariant of SARS-CoV-2 to help prevent COVID-19. <Read More> 

Nuvaxovid™ (COVID-19 Vaccine, Adjuvanted) Injectable Suspension – August 27, 2026 – Novavax, Inc.'s (Nasdaq: NVAX) partners have received approvals for the Nuvaxovid™ formulation to target the SARS-CoV-2 XFG variant for the 2026-2027 vaccination season in major markets including the U.S., European Union (EU) and Japan. These approvals position Novavax to continue earning royalties on net sales in these markets this season. <Read More> 

Comirnaty® (COVID-19 Vaccine, mRNA) Injection – New Expanded Label – August 27, 2026 – Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ 2026-2027 COVID-19 vaccine formula targeting the XFG variant (Comirnaty® XFG; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. <Read More> 

Mounjaro® (tirzepatide) Injection – New Expanded Label – August 27, 2026 – Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) approved Mounjaro® (tirzepatide), a dual GIP and GLP-1 hormone receptor agonist, to lower the risk of major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes who are at high risk for these events. <Read More> 

Tevimbra® (tislelizumab-jsgr) Injection – New Expanded Label – August 25, 2026 – BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Tevimbra® (tislelizumab) in combination with Ziihera® (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive (HER2+) gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA). <Read More> 

New Drug Shortage

September 21, 2026

• Arsenic Trioxide Injection (Discontinuation)

September 18, 2026

• Rivaroxaban For Suspension (Discontinuation)

• Rivastigmine Film, Extended Release (Discontinuation)

September 16, 2026

• Melphalan Hydrochloride Injection (Discontinuation)

• Mesalamine Capsule, Extended Release (Discontinuation)

September 11, 2026

• Cisatracurium Besylate Injection (Discontinuation)

• Micafungin Sodium Injection (Discontinuation)

September 10, 2026

• Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride Solution (Discontinuation)

Updated Drug Shortage

September 22, 2026

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently in Shortage)

• Carboplatin Injection (Currently in Shortage)

• Dobutamine Hydrochloride Injection (Currently in Shortage)

• Dopamine Hydrochloride Injection (Currently in Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently in Shortage)

• Fentanyl Citrate Injection (Currently in Shortage)

• Furosemide Injection (Currently in Shortage)

• Heparin Sodium Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Lorazepam Injection (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Sodium Bicarbonate Injection (Currently in Shortage)

September 21, 2026

• Clindamycin Phosphate Injection (Currently in Shortage)

• Methylprednisolone Acetate Injection (Currently in Shortage)

• Penicillin G Benzathine Injection (Currently in Shortage)

September 18, 2026

• Bumetanide Injection (Currently in Shortage)

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

• Fentanyl Citrate Injection (Currently in Shortage)

• Furosemide Oral Solution (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Lisdexamfetamine Dimesylate Tablet, Chewable (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Methylphenidate Hydrochloride Tablet, Extended Release (Currently in Shortage)

• Methylprednisolone Acetate Injection (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Promethazine Hydrochloride Injection (Currently in Shortage)

• Technetium TC-99M Pyrophosphate Kit Injection (Currently in Shortage)

September 17, 2026

• Carboplatin Injection (Currently in Shortage)

• Clindamycin Phosphate Injection (Currently in Shortage)

• Dextrose Monohydrate 10% Injection (Currently in Shortage)

• Dextrose Monohydrate 5% Injection (Currently in Shortage)

• Dextrose Monohydrate 70% Injection (Currently in Shortage)

• Ifosfamide Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

September 16, 2026

• Desmopressin Acetate Spray (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Streptozocin Powder, For Solution (Currently in Shortage)

New Drug Recall and Safety Alerts

Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection – September 18, 2026 - Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellulose or stopper material. <Read More> 

Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP – September 17, 2026 - Otsuka ICU Medical LLC is issuing a voluntary recall for one lot of 0.9% Sodium Chloride Injection, USP, 100mL single pack to the user level due to a potential mix-up. The affected lot of 0.9% Sodium Chloride Injection, USP (NDC: 0990-7984-23 Lot 1042188) may potentially contain the overwrap with labeling indicating it to be 0.9% Sodium Chloride Injection, USP (NDC: 0990-7984-23) but the actual product within the overwrap may be Potassium Chloride Inj. 10 mEq, (NDC 0990-7074-26) Lot 1035181. <Read More> 

B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container – September 3, 2026 - B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron oxide, inorganic, cellulose or polystyrene particulate matter. <Read More>

Baxter Issues Voluntary Nationwide Recall for Two Lots of 0.9% Sodium Chloride Injection – August 25, 2026 - Baxter International Inc. (NYSE:BAX) is voluntarily recalling two lots of 0.9% Sodium Chloride Injection due to the potential presence of particulate matter identified as fiberglass in the solution. <Read More> 

Baxter Issues Voluntary Nationwide Recall for One Lot of Anticoagulant Sodium Citrate Solution – August 25, 2026 - Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Anticoagulant Sodium Citrate Solution due to the potential presence of particulate matter identified as fiberglass in the solution. <Read More>

Baxter Issues Voluntary Nationwide Recall for One Lot of 70% Dextrose Injection – August 25, 2026 - Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of 70% Dextrose Injection due to the potential presence of particulate matter identified as stainless steel particles in the solution. <Read More> 

New Generic/Biosimilar Approval and Launch

Bravnetsa™ (lutetium Lu 177 dotatate) Injection – New Lutathera® Biosimilar Approval – September 21, 2026 – Lantheus Holdings, Inc. ("Lantheus" or the "Company") (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 granted final approval for Bravnetsa™ (lutetium Lu 177 dotatate), a bioequivalent and therapeutically equivalent radiopharmaceutical to Lutathera® (lutetium Lu 177 dotatate). <Read More>

Clinical and Pharmacy News

Navigating GLP-1 Switches: A Guide for Primary Care – September 29, 2026 - As GLP-1 receptor agonists and dual incretin agents become more common in treating obesity and type 2 diabetes, primary care providers are handling more medication switches. The reason may be insurance coverage, ongoing gastrointestinal side effects, inadequate response, or the need for better blood sugar control or weight support. Whatever the driver, switching is not simply trading one prescription for another. It requires planning around half-lives, dose history, side effects, and the risk for blood sugar swings. <Read More> 

Insurance Coverage Lags as Cancer Science, Treatment Move Forward – September 24, 2026 - Eighteen months after his initial diagnosis, chemotherapy hadn’t slowed 21-year-old Mason Henderson’s rare brain tumor, which had spread to his spinal fluid. So, he left his home in southeastern Texas to spend three weeks in a clinical trial in New York City. But that failed, too, leaving a murky path for Henderson, whose cancer was so rare the World Health Organization had only given it a name in 2021. So early this year, Henderson’s doctors, evaluating his tumor’s deep genetic language, turned to a drug made by Merck and AstraZeneca called Lynparza®. <Read More> 

Cholesterol Control Gets Personalized—How New Guidelines Tailor Treatment to Your Unique Risk Profile – September 24, 2026 – As a cardiologist with expertise in sports and exercise science, I routinely care for patients who want to make healthy lifestyle choices to control their cholesterol levels, reduce their risk of cardiovascular disease and improve their overall health. In March 2026, the American Heart Association and the American College of Cardiology issued new guidelines on how to treat dyslipidemia. The guidelines, last updated in 2018, incorporate findings from several new studies on how to more effectively treat—and prevent—the condition. The new guidelines can help doctors personalize treatment to reduce each patient's risk of developing cardiovascular disease. <Read More> 

VA/DoD Release Updated Tobacco Cessation Clinical Practice Guidelines – September 22, 2026 - The US Department of Veterans Affairs (VA) and Department of Defense (DoD) have released an updated clinical practice guideline recommending varenicline or combination nicotine replacement therapy as the preferred treatments for tobacco cessation, according to a synopsis published in Annals of Internal Medicine. The updated guidance addresses nicotine and tobacco use among service members and veterans, noting that use leads to adverse physical and mental health effects, and reduces military force readiness. For respiratory therapists and allied healthcare professionals treating patients with chronic lung conditions and nicotine dependence, the document outlines practical strategies to improve long-term abstinence rates. <Read More>

Generic Drug Costs Burdening Patients as Much as Brand Name Options – September 18, 2026 - Aggregate OOP burden for generics exceeds brands due to utilization intensity, especially among Medicare beneficiaries with higher generic fill counts and near-parity annual OOP spending versus brands. Cost-related nonadherence remains substantial, with reported treatment abandonment and dose modification, positioning community pharmacists as key actors in mitigating downstream acute-care utilization. <Read More> 

Specialty Pharmacy Leaders to Convene for NASP inSPire2026 – September 18, 2026 - As specialty pharmacy addresses the rising cost and complexity of cell and gene therapies, this year's newly rebranded inSPire2026 meeting will bring pharmacists, nurses, and industry leaders together to chart how those breakthroughs actually reach patients. From September 22 to 25, 2026, specialty pharmacy professionals gathered for inSPire2026, the newly rebranded successor to the National Association of Specialty Pharmacy's (NASP) Annual Meeting & Expo. <Read More> 

340B in the News

340B Hospitals Lag Behind Peers in Charity Care Spending: Report – September 25, 2026 - A new report from a conservative think tank is accusing 340B hospitals of providing less charity care than other nonprofit hospitals, despite receiving discounted drugs. Hospitals participating in the 340B drug discount program spent 2.16% of their operating expenses on free or discounted care for low-income patients, called charity care, compared with 2.82% at non-340B hospitals, according to a Thursday analysis from the Pioneer Institute and CancerCare. <Read More> 

What the Revised 340B Rebate Pilot Programme Means for Pharma Revenue Operations – September 24, 2026 - The US government's revised 340B rebate pilot programme signals that pharmaceutical manufacturers need to prepare their operations for the next phase of drug discount management. The pilot shifts how pharmaceutical manufacturers provide 340B discounts to eligible hospitals and healthcare providers. The savings for certain medications will now come in the form of rebates, rather than upfront discounts. Under this new arrangement, covered entities must purchase selected Medicare negotiation drugs at the wholesale acquisition cost (WAC) or negotiated prices, then seek a manufacturer refund for the difference to the 340B price. <Read More> 

The 340B Debate Can’t Ignore Supply Chain Realities – September 23, 2026 - Healthcare distributors deliver roughly 15 million medicines and healthcare products every day to hospitals, physicians’ offices, pharmacies, and other providers across the country. While they play a critical role in keeping the healthcare supply chain moving, they are largely removed from the design and operation of the 340B Drug Pricing Program. As lawmakers debate changes to 340B, it is essential to recognize the distinct role distributors serve — and avoid policies that assign them responsibility for decisions they do not control. <Read More> 

Johnson & Johnson Next Major Drugmaker to Require 340B Claims Data – September 18, 2026 - Johnson & Johnson now requires comprehensive pharmacy/medical claims elements to be submitted to its 340B ESP platform, with suspension of all 340B pricing within five business days after repeated noncompliance. Eli Lilly’s January 2026 policy expanded reporting to in-house dispensing and provider-administered drugs, enforcing 45–60 day deadlines and threatening termination, with suspensions already prompting litigation. <Read More> 

Utilizing 340B Margin to Create a Patient Prescription Assistance Program – September 16, 2026 - Medicaid work/volunteer/school hour verification and 6-month renewals may drive coverage losses, disrupting continuity and access to specialty drugs among adults aged 19 to 64 years in expansion populations. Manufacturer restrictions on 340B pricing and claims-submission requirements add administrative burden and risk multimillion-dollar annual acquisition-cost increases for noncompliant safety-net health systems. Hospital-owned specialty pharmacies can fund PAPs with 340B savings to lower patient cost exposure, improve adherence, reduce abandonment, and mitigate reliance on external subsidies or foundations. <Read More> 

New Drug/Vaccine Approval

Pasatru™ (garetosmab-grts) Injection – New Drug Approval – August 19, 2026 - Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the U.S. Food and Drug Administration (FDA) has granted approval for Pasatru™ (garetosmab-grts) to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). Recognizing the significant mobility challenges faced by many people with FOP, Pasatru can be administered across a range of care settings, including home infusion where appropriate. <Read More>  

Genglycos™ (pariglasgene brecaparvovec-opnr) Suspension for Intravenous Infusion - formerly DTX401 – New Drug Approval – August 19, 2026 - Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Genglycos™ (pariglasgene brecaparvovec-opnr), also known as DTX401, in adult and pediatric patients eight years and older with glycogen storage disease type Ia (GSDIa). <Read More>  

Zenbexus™ (iberdomide) Capsules – New Drug Approval – August 13, 2026 - The Food and Drug Administration granted accelerated approval to iberdomide (Zenbexus™, Bristol-Myers Squibb Company) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. <Read More>  

Tauklarify™ (florquinitau F 18) Injection - formerly MK-6240 – New Drug Approval – August 13, 2026 - Lantheus Holdings, Inc. ("Lantheus" or the "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced U.S. Food and Drug Administration (FDA) approval of Tauklarify™ (florquinitau F 18 injection), also referred to as MK-6240, a radiodiagnostic agent indicated for positron emission tomography (PET) of the brain in adults with cognitive impairment who are being evaluated for Alzheimer's disease to identify patients with tau neurofibrillary tangle (NFT) pathology. <Read More>  

Tudriqev™ (vusolimogene oderparepvec-wtpg) Suspension for Intratumor Injection – New Drug Approval – August 6, 2026 - The Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev™, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. <Read More>  

Orzeyful™ (oveporexton) Tablets – New Drug Approval – August 5, 2026 - Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) approved Orzeyful™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults. The persistent 24-hour nature of NT1 is driven by orexin deficiency and can severely impact people's lives. As a first-in-class orexin treatment, ORZEYFUL is the only medicine indicated in the U.S. to treat the disease holistically rather than individual symptoms. <Read More>  

mFLUSIVA® (influenza vaccine, mRNA) Injection - formerly mRNA-1010 – New Drug Approval – August 5, 2026 - Moderna, Inc. (NASDAQ:MRNA) announced that the U.S. Food and Drug Administration (FDA) has approved mFLUSIVA® (mRNA-1010), a new vaccine against seasonal influenza, for use in all adults 50 years and older. This approval follows unanimous recommendations from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) supporting mFLUSIVA® – for adults 50 years of age and older. <Read More> 

Gwyn Lo™ (ethinyl estradiol and norelgestromin) Transdermal System – New Drug Approval – July 28, 2026 - Viatris Inc. (Nasdaq: VTRS), a global healthcare company, announced that the U.S. Food and Drug Administration (FDA) has approved Gwyn Lo™ (norelgestromin and ethinyl estradiol transdermal system). Gwyn Lo™ is a new combined hormonal contraceptive (CHC) patch with low-dose estrogen. The patch has demonstrated contraceptive efficacy for women of childbearing potential with a body mass index (BMI) below 30 kg/m® who are appropriate candidates for CHC. The Gwyn Lo™ dosage is norelgestromin 220 mcg/day and ethinyl estradiol 20 mcg/day. <Read More> 

New Label Expansions

Imaavy® (nipocalimab-aahu) Injection – New Expanded Label – August 24, 2026 – Johnson & Johnson (NYSE: JNJ) announced the U.S. Food and Drug Administration (FDA) approval of Imaavy® (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) – a rare, life-threatening autoantibody disease – in adults and pediatric patients 12 years of age and older currently or previously treated with corticosteroids. <Read More> 

Lerochol® (lerodalcibep-liga) Injection - New Expanded Label – August 13, 2026 – LIB Therapeutics, Inc. (LIB)… announced the U.S. Food and Drug Administration (FDA) has approved an autoinjector for Lerochol® (lerodalcibep-liga) Injection 300 mg/1.2 mL, a third-generation Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor that combines robust and sustained efficacy with once-monthly, single injection self-administration to support long-term adherence. <Read More> 

Pluvicto® (lutetium lu 177 vipivotide tetraxetan) Injection - New Expanded Label – July 31, 2026 - Novartis announced the US Food and Drug Administration (FDA) approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer, commonly known as metastatic hormone-sensitive prostate cancer (mHSPC). <Read More> 

New Drug Shortage

August 25, 2026

• Liraglutide Injection (Discontinuation)

• Mesalamine Capsule, Extended Release (Discontinuation)

August 24, 2026

• Disopyramide Phosphate Capsule, Extended Release (Discontinuation)

August 14, 2026

• Fulvestrant Injection (Discontinuation)

August 13, 2026

• Diclofenac Sodium Tablet, Delayed Release (Discontinuation)

• Polyethylene glycol 3350, Sodium Ascorbate, Sodium Sulfate Anhydrous, Ascorbic Acid, Sodium Chloride, and Potassium Chloride Oral Solution (Discontinuation)

August 10, 2026

• Glyburide Tablet (Discontinuation)

Updated Drug Shortage

August 25, 2026

• Dexamethasone Sodium Phosphate Injection (Currently in Shortage)

• Liraglutide Injection (Currently in Shortage)

• Rifampin Injection (Currently in Shortage)

August 24, 2026

• Atropine Sulfate Injection (Currently in Shortage)

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently in Shortage)

• Desmopressin Acetate Spray (Currently in Shortage)

• Dextrose Monohydrate 50% Injection (Currently in Shortage)

• Dobutamine Hydrochloride Injection (Currently in Shortage)

• Dopamine Hydrochloride Injection (Currently in Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Methylprednisolone Acetate Injection (Currently in Shortage)

• Penicillin G Benzathine Injection (Currently in Shortage)

August 21, 2026

• Bumetanide Injection (Currently in Shortage)

August 20, 2026

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Currently in Shortage)

August 18, 2026

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Currently in Shortage)

• Clindamycin Phosphate Injection (Currently in Shortage)

• Furosemide Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Metronidazole Injection (Currently in Shortage)

• Rifampin Capsule (Currently in Shortage)

New Drug Recall and Safety Alerts

Thyroid Tablets, USP 30 mg by Vitruvias Therapeutics, Inc – New Voluntary Recall – August 21, 2026 - Vitruvias Therapeutics Inc. is voluntarily recalling one lot (Lot. No. 504950) of Thyroid Tablets, USP 30 mg to the consumer level. The product is being recalled because testing confirmed the potential for the product to be superpotent. <Read More> 

Glutathione 200 mg/mL Multi-Dose Vials by Optimal Balance Pharmacy – New Voluntary Recall – August 19, 2026 - Optimal Balance Pharmacy is voluntarily recalling one lot of Compounded Glutathione 200 MG/ML 30 ML Multi-Dose Vials to the patient level. The product is being recalled because pharmacy testing identified elevated bacterial endotoxin levels. <Read More> 

Excel® Lactated Ringers Injection, 1000mL by B. Braun Medical Inc. – New Voluntary Recall – August 19, 2026 - B. Braun Medical Inc (B. Braun), is voluntarily recalling one lot of Excel® Lactated Ringers Injection, 1000mL to the hospital/healthcare facility level, due to the presence of particulate matter in solution identified primarily as cellulose cotton fibers, with individual particles also identified as cellulose wood fiber and polystyrene. <Read More> 

Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL Vials by Fresenius Kabi – New Voluntary Recall – August 10, 2026 - Fresenius Kabi, an operating company of the Fresenius Group, is recalling one lot of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 mL vials to the user level. An internal investigation at the firm found the product to contain glass particles. <Read More> 

Morphine Sulfate Injection, USP in a Simplist® Prefilled Syringe by Fresenius Kabi – New Voluntary Recall – August 4, 2026 - Fresenius Kabi, an operating company of the Fresenius Group, is voluntarily recalling one lot of Morphine Sulfate Injection USP, Simplist® – 2 mg/1 mL due to a label mix-up. The MicroVault labeled as morphine 2 mg/1 mL, may contain a Prefilled Syringe of Dilaudid® – 0.5 mg/0.5 mL. This recall is being conducted to the user level. <Read More> 

Optiray® Imaging Bulk Package - 350, 500mL, Vial by Liebel-Flarsheim Company, LLC – New Voluntary Recall – July 31, 2026 - Liebel-Flarsheim Company, LLC, is recalling one lot of Optiray® Imaging Bulk Package (IBP) 350, 500mL in vial, (Ioversol Injection 74% 350 mg iodine/ml) for intra-arterial or intra-venous use to the user level (hospitals, imaging centers, healthcare facilities and clinics, and other potential users of the product) due to the presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass. <Read More> 

New Generic/Biosimilar Approval and Launch

No new update

Clinical and Pharmacy News

Hidden Single-Source Risk Behind Generic Drug Supply – August 24, 2026 - Healthcare procurement teams have spent years building redundancy into pharmaceutical purchasing. A critical generic may have multiple approved manufacturers, multiple distributors and several products available for substitution, and on paper that looks diversified. Upstream, it can be something very different, and the deeper problem is that the usual numbers can still understate just how concentrated that dependency really is. <Read More> 

Fewer Employers are Covering GLP-1 Drugs for Weight Loss. Should They? – August 24, 2026 - Two recent news items reveal countervailing trends in employer health insurance coverage for GLP-1 drugs, the highly effective and highly expensive medications for treating diabetes and obesity. The insurer Cigna reported a pullback in coverage of GLP-1 drugs for weight loss. Six percent of large employers dropped coverage in 2026, according to Bloomberg. Meanwhile, Bank of America is doubling down. It's continuing to cover GLP-1s for weight loss (in addition to covering them to treat diabetes), while also providing healthcare and lifestyle coaching for those on the drugs – at a cost of $250 million a year. That now represents 13% of the company's total healthcare spending. <Read More> 

REMS Removed: Why CAR-T's Expansion into Community Oncology Could Benefit the Big Three Wholesalers – August 18, 2026 – The FDA's removal of CAR-T REMS requirements eliminates one obstacle to expanding treatment beyond traditional academic medical centers. That change could disproportionately benefit the Big Three wholesalers, which have spent billions building positions in community oncology while simultaneously investing in cell-and-gene-therapy distribution and support infrastructure. <Read More> 

Panel Offers First Guidelines for Using E-Cigarettes to Help Smokers Quit – August 18, 2026 - A panel of experts has issued the first clinical guidelines for using e-cigarettes to help adults quit smoking. E-cigarettes should be offered alongside other smoking cessation strategies like nicotine replacement therapies or medications like varenicline and bupropion, a panel from the Society for Research on Nicotine and Tobacco said. Its recommendations were published recently in the Journal of the American Medical Association. <Read More> 

States Should Not Wait Until 2028 to Open PBMs' Books – August 18, 2026 - Prescription drug prices do not become opaque by accident. They become opaque because the middlemen who manage drug benefits are allowed to hide many of their revenue streams from the employers, insurers, pharmacies, and patients who ultimately pay the bill. Congress has already recognized the problem. Federal pharmacy benefit manager (PBM) reporting requirements are scheduled to reshape what PBMs must disclose, but many of the most important provisions will not take effect until 2028. That delay creates a basic question for state lawmakers: why wait? <Read More> 

Clinical Guidance: Malaria Diagnosis and Treatment in the U.S. – August 17, 2026 - Approximately 2,000 cases of malaria are reported annually in the United States, primarily among travelers. Malaria can be a severe, potentially fatal disease. Urgent diagnosis followed by immediate treatment is critical. Healthcare providers in the United States can use this guidance to ensure appropriate diagnosis and treatment of malaria. As of August 2026, guidance extends artemether-lumefantrine duration to 5 days (10 doses) for Plasmodium falciparum malaria, both for the treatment of uncomplicated infections and following IV artesunate for severe infections. <Read More> 

Employers Tighten Benefits Cost Oversight as Medical and Pharmacy Pressures Mount – August 17, 2026 - More than a third of employers reported health plan premium increases of 10% or more at their latest renewal, and pharmacy and voluntary benefits are facing similar scrutiny, according to Gallagher. Medical cost pressure is intensifying even as employers make changes to health care plans intended to control it, according to Gallagher's U.S. Benefits Strategy & Benchmarking Survey. <Read More> 

Major PBMs to Boost Prescription Drug Price Transparency Through TrumpRx – August 13, 2026 - A group of nine pharmacy benefit managers (PBMs) announced Thursday that they will work with an industry group to boost the transparency of prescription drug pricing through the TrumpRx platform. Fox Business exclusively learned that the Pharmaceutical Care Management Association (PCMA) and nine PBMs reached an agreement to showcase the cash price of prescriptions from TrumpRx within their benefit tools. The agreement aims to give patients better visibility into the cost of the medication and how they might save money on it. <Read More> 

Employer Survey Signals Coming Shakeup in PBM Market Dynamics – August 13, 2026 – Employers are increasingly shifting business away from the big three pharmacy benefit managers of Express Scripts Inc., CVS Caremark and UnitedHealth Group's OptumRx, according to a survey released Wednesday. The three companies – which manage prescription drugs for health plans – are believed to control 80% of the market, and have garnered blowback from Congress and state regulators over opaque pricing practices and pressure on local pharmacies. <Read More> 

From Blame to Data: How Medication Error Reporting Systems Drive Patient Safety – August 12, 2026 - A single medication error can have devastating consequences for patients, pharmacists, and institutions. Globally, medication-related errors are responsible for approximately 5% to 41% of all hospital admissions and 22% of readmissions. The annual costs associated with medication errors globally are approximately $42 billion. Error reporting and analysis can only decrease error rates if health care shifts its culture from one of punitive blame to one that treats errors as systemic data points for identification and correction. This requires a robust, nonpunitive reporting system coupled with systematic analysis to prevent future harm. <Read More> 

The New Era of Pharma Distribution: Balancing Precision and Scale – July 14, 2026 - Specialty medicines comprise ~75% of ~7,000 pipeline assets, with nearly 180 advanced therapies expected by 2030, accelerating demand for scalable, operationally sustainable distribution models. Cold-chain exposure is rising, with ~50% of launches through 2027 requiring temperature control; 3PLs are expanding ambient-to-cryogenic capacity, including ultra-low and liquid-nitrogen storage. <Read More> 

340B in the News

HRSA Revives the 340B Rebate Pilot: Covered Entities Should Prepare Now for 2027 – August 18, 2026 - HRSA is again moving toward a 340B rebate model, and covered entities should begin preparing for the possibility that the way they purchase certain 340B drugs will change on January 1, 2027. On July 31, 2026, the Health Resources and Services Administration (HRSA) announced a revised 340B Rebate Model Pilot Program. The proposal would allow qualifying manufacturers to provide the 340B ceiling price for certain drugs through a post-purchase rebate rather than the upfront discount that has long been the norm in the 340B Program. <Read More> 

340B Drug Payment Cuts Headline CMS Proposal to Lower Medicare Costs – July 7, 2026 – CMS proposes paying 340B-acquired drugs at ASP minus 33.4% starting CY 2027, replacing ASP plus 6%, based on survey findings that acquisition costs are well below ASP. Projected 2027 impact includes $1.15 billion lower Original Medicare beneficiary drug costs and $4.55 billion reduced taxpayer spending, with OPPS budget neutrality offsetting via increased non-drug payments. <Read More> 

New Drug/Vaccine Approval

Lytenava™ (bevacizumab-vikg) Intravitreal Injection - formerly ONS-5010 – New Drug Approval – July 24, 2026 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/Lytenava™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Lytenava™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD), commonly known as wet AMD. <Read More> 

Simtriyo® (centanafadine) Extended-Release Capsules – New Drug Approval – July 24, 2026 – Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announced that the U.S. Food and Drug Administration (FDA) has granted approval of Simtriyo® (centanafadine), a once-daily extended-release capsule for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older weighing at least 20kg. <Read More> 

Tylenol® with Naproxen (acetaminophen and naproxen sodium) Tablets – New Drug Approval – July 24, 2026 – FDA approved Tylenol® with Naproxen (acetaminophen 325 mg/naproxen sodium 110 mg tablets), the first fixed-dose combination product to pair acetaminophen with naproxen sodium in a single combination tablet for up to 12 hours of pain relief. This nonprescription product is indicated for the temporary relief of minor aches and pains due to headache, backache, muscular aches, toothache, menstrual cramps, and minor pain of arthritis in adults and children 12 years and older. <Read More> 

Jideytro™ (zidesamtinib) Tablets - New Drug Approval – July 22, 2026 – The Food and Drug Administration approved zidesamtinib (Jideytro™, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI). <Read More>  

Lipfendra® (enlicitide) Tablets – New Drug Approval – July 16, 2026 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has approved Lipfendra® (enlicitide) tablets 20 mg as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Lipfendra® is a novel macrocyclic peptide and is the first FDA-approved oral PCSK9 inhibitor shown to lower LDL-C, also known as bad cholesterol. <Read More>

Revtorpyk™ (gedatolisib) Lyophilized Powder for Injection – New Drug Approval – July 14, 2026 – Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor indications, announced that the U.S. Food and Drug Administration (“FDA”) approved Revtorpyk™ (gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. <Read More> 

Sarclisa Escena™ (isatuximab-irfc) Subcutaneous Injection – New Drug Approval – July 9, 2026 – The US Food and Drug Administration (FDA) has approved subcutaneous (SC) Sarclisa (isatuximab-irfc) Escena™ in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all existing indications of Sarclisa intravenous (IV) formulation. With the approval, Sarclisa Escenaä is the first anticancer treatment to be administered through both an on-body injector (OBI) and manual SC administration. <Read More> 

Trutakna™ (atacicept-vymj) Injection – New Drug Approval – July 7, 2026 – Vera Therapeutics, Inc. (Nasdaq: VERA), a commercial-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted Trutakna™ (atacicept-vymj) accelerated approval to reduce proteinuria in adults with primary IgAN at risk for disease progression. In a prespecified interim analysis of the ongoing ORIGIN 3 trial, participants treated with Trutakna™ achieved a 46% reduction from baseline in proteinuria, with a statistically significant and clinically meaningful 42% reduction compared to placebo (p<0.0001) at 36 weeks. In this registrational program, Trutaknaä was generally well tolerated. The most common adverse reactions were infections and local administration reactions. <Read More> 

New Label Expansions

Furoscix™ (furosemide) Injection - New Label Expansion – New Dosage Regimen: July 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 Furoscix ReadyFlow™ (furosemide injection) for the treatment of edema (fluid overload) in adults with heart failure (HF) or chronic kidney disease (CKD). <Read More> 

Fabhalta® (iptacopan) Capsules - New Label Expansion – Labeling Revision Approved: July 16, 2026 - Novartis announced that the US Food and Drug Administration (FDA) has granted traditional approval for Fabhalta® (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. Fabhalta®, a first-in-class complement inhibitor, received approval under a priority review designation after an initial FDA accelerated approval in August 2024 for the reduction of proteinuria in primary IgAN. <Read More>

Retevmo® (selpercatinib) Capsules and Tablets - New Label Expansion – Labeling Revision Approved: July 14, 2026 - The Food and Drug Administration granted traditional approval to selpercatinib (Retevmo®, Eli Lilly and Company) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. Selpercatinib received accelerated approval for this indication for adult patients in 2022 and for pediatric patients two years of age and older in 2024. <Read More> 

Leqembi® (lecanemab-irmb) Injection - New Label Expansion – New Indication Approved: July 13, 2026 - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (brand name: Leqembi Iqlik®) as an initiation dose for the treatment of early Alzheimer’s disease. <Read More> 

Keytruda® (pembrolizumab) for Injection - New Label Expansion – New Indication Approved: July 10, 2026 - the Food and Drug Administration approved pembrolizumab (Keytruda®, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex®, Merck) each in combination with enfortumab vedotin-ejfv (Padcev®, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle invasive bladder cancer (MIBC). This extends the prior approval for the regimen in this setting from patients who are cisplatin-ineligible to all patients with MIBC who are candidates for cystectomy. <Read More> 

Padcev® (enfortumab vedotin-ejfv) Lyophilized Powder for Injection - New Label Expansion – New Indication Approved: July 10, 2026 - Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) announced that the U.S. Food and Drug Administration (FDA) has approved Padcev® (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, plus the PD-1 inhibitor, Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) as neoadjuvant and adjuvant (before and after surgery) treatment for adult patients with muscle-invasive bladder cancer regardless of cisplatin eligibility. <Read More> 

Ryaltris® (mometasone furoate and olopatadine hydrochloride) Nasal Spray - New Label Expansion – Patient Population Altered: July 7, 2026 - Glenmark Specialty S.A. (Glenmark) announced that U.S. FDA has approved the expanded use of Ryaltris® (olopatadine hydrochloride and mometasone furoate) Nasal Spray, 665 mcg/25 mcg per spray, for the treatment of symptoms of Seasonal Allergic Rhinitis (SAR) in pediatric patients aged 6 to less than 12 years. <Read More> 

wilate® (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) Injection - New Label Expansion – Patient Population Altered: July 2, 2026 - the U.S. Food and Drug Administration (FDA) approved the use of wilate® (von Willebrand Factor/Coagulation Factor VIII Complex [Human]) for routine prophylaxis to reduce the frequency of bleeding episodes in pediatric patients with von Willebrand Disease (VWD) who are younger than 6 years of age. This approval expands access to the first von Willebrand Factor (VWF) concentrate indicated for prophylactic treatment across all ages and forms of VWD, the most common inherited bleeding disorder. <Read More> 

Casgevy® (exagamglogene autotemcel) Suspension for Intravenous Infusion - New Label Expansion – Patient Population Altered: July 1, 2026 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the U.S. Food and Drug Administration (FDA) has approved expanded use of Casgevy® (exagamglogene autotemcel) for the treatment of people ages 2 years and older with either sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent beta thalassemia (TDT). CASGEVY is the first approved genetic therapy indicated for children as young as 2 years for both SCD and TDT. <Read More> 

New Drug Shortage

July 27, 2026

• Fluticasone Propionate and Salmeterol Xinafoate Aerosol, Metered (Discontinuation)

July 24, 2026

• Lopinavir and Ritonavir Oral Solution (Discontinuation)

• Lopinavir and Ritonavir Tablet (Discontinuation)

• Ritonavir Oral Powder (Discontinuation)

• Ritonavir Tablet (Discontinuation)

July 23, 2026

• Aspirin Suppository (Discontinuation)

• Belladonna and Opium Suppository (Discontinuation)

• Bendamustine Hydrochloride Injection, Solution (Discontinuation)

• Hydrocortisone Acetate Suppository (Discontinuation)

• Hydromorphone Hydrochloride Suppository (Discontinuation)

• Morphine Sulfate Suppository (Discontinuation)

• Podophyllum Resin Topical Tincture (Discontinuation)

• Succinylcholine Chloride Injection (Discontinuation)

July 20, 2026

• Atropine Sulfate Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Sodium Acetate Injection (Currently in Shortage)

July 17, 2026

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

Updated Drug Shortage

July 23, 2026

• Atropine Sulfate Injection (Currently in Shortage)

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently in Shortage)

• Dextrose Monohydrate 50% Injection (Currently in Shortage)

• Dobutamine Hydrochloride Injection (Currently in Shortage)

• Dopamine Hydrochloride Injection (Currently in Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently in Shortage)

• Etomidate Injection (Currently in Shortage)

• Fentanyl Citrate Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Lisdexamfetamine Dimesylate Tablet, Chewable (Currently in Shortage)

• Lorazepam Injection (Currently in Shortage)

• Meperidine Hydrochloride Injection (Currently in Shortage)

• Methylphenidate Hydrochloride Tablet, Extended Release (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Sodium Bicarbonate Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

• Sufentanil Citrate Injection (Currently in Shortage)

• Technetium TC-99M Pyrophosphate Kit Injection (Currently in Shortage)

• Triamcinolone Acetonide Injection (Currently in Shortage)

July 22, 2026

• Methylprednisolone Acetate Injection (Currently in Shortage)

• Penicillin G Benzathine Injection (Currently in Shortage)

July 21, 2026

• Azacitidine Injection (Currently in Shortage)

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently in Shortage)

• Carboplatin Injection (Currently in Shortage)

• Dexamethasone Sodium Phosphate Injection (Currently in Shortage)

• Dextrose Monohydrate 5% Injection (Currently in Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently in Shortage)

• Fentanyl Citrate Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Ifosfamide Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Remifentanil Hydrochloride Injection (Currently in Shortage)

• Rifampin Injection (Currently in Shortage)

• Ropivacaine Hydrochloride Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

July 20, 2026

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

• Carboplatin Injection (Currently in Shortage)

• Dexamethasone Sodium Phosphate Injection (Currently in Shortage)

• Dextrose Monohydrate 5% Injection (Currently in Shortage)

• Furosemide Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Ropivacaine Hydrochloride Injection (Currently in Shortage)

• Technetium TC-99M Pyrophosphate Kit Injection (Currently in Shortage)

July 19, 2026

• Clindamycin Phosphate Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Dextrose Monohydrate 70% Injection (Currently in Shortage)

• Heparin Sodium Injection (Currently in Shortage)

• Ifosfamide Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Sterile Water Irrigant (Currently in Shortage)

New Drug Recall and Safety Alerts

Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL by American Regent, Inc. - New Voluntary Recall – July 24, 2026 - American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consumer level. The product is being recalled due to the presence of particulate matter identified as glass and/or paraformaldehyde. <Read More>

Cefazolin in Dextrose Injection, USP, 2g / 100ml (20mg/ml) Single-Dose Infusion Bag in 100ml by Baxter - New Voluntary Recall – July 24, 2026 – Baxter International Inc. (NYSE:BAX) is voluntarily recalling Lot LD175708, Exp 14-Feb 2027 of Cefazolin in Dextrose Injection due to a report of particulate matter found in the solution identified as cardboard. <Read More> 

Cyclophosphamide for Injection, USP by Sunny Pharmtech, Inc. - New Voluntary Recall – July 24, 2026 - Sunny Pharmtech, Inc is voluntarily recalling three lots of Cyclophosphamide for Injection, USP, 1g/vial and 2g/vial, to the User Level due to the presence of particulate matter identified as steel. To date, no adverse events or injuries associated with this particulate matter issue have been reported. <Read More> 

Cetirizine Hydrochloride Tablets USP 5 mg by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) – New Voluntary Recall – July 18, 2026 – Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) is voluntarily recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg to the consumer level due to cross contamination with Ranitidine. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Stopping Medications Safely Is Hard. This Federal Guidance Could Change Everything – July 28, 2026 - Deprescribing doesn’t mean stopping medications on your own. It refers to the supervised process of reducing or discontinuing drugs that may no longer provide more benefit than harm. Many people stay on medications longer than necessary. Over time, prescriptions can accumulate, increasing the risk of side effects, drug interactions, and falls. New Medicare guidance could make deprescribing more common. Clinicians may be able to bill for the work involved in safely tapering medications under existing Medicare care-management services. Pharmacists could play a much larger role. The guidance may help expand pharmacist-led medication management programs that review whether each medication is still necessary. <Read More> 

New STS Guideline Tackles the Prevention of AFib After Cardiac Surgery – July 28, 2026 - A new clinical guidance from the Society of Thoracic Surgeons (STS) recommends being more aggressive with amiodarone and posterior pericardiotomy to prevent new-onset atrial fibrillation (AFib) after cardiac surgery. Cardiovascular Business spoke to Subhasis Chatterjee, MD, lead author of that guideline and director of the Thoracic Surgical ICU and ECMO Program at Baylor St. Luke's Medical Center, to learn more. He outlined key recommendations from the document, which was based on data found and reviewed by experts from the fields of cardiac surgery, cardiology, critical care and anesthesiology. <Read More> 

New Guideline Will Shift Statins to Younger and Lower-Risk U.S. Adults – July 20, 2026 - Three studies used nationally representative survey data to project how the new dyslipidemia guideline would affect population health. A large percentage of U.S. adults age 30 or older were new candidates for guideline-directed lipid-lowering therapy based on updated guideline criteria, one study showed. Another study found that in those age 40-79, the proportion of people who may be recommended lipid-lowering therapy was 49.6% with the 2026 guideline versus 49.4% before the guideline. <Read More> 

GLP-1 Use Rising Rapidly Among U.S. Adolescents, Young Adults – July 20, 2026 - Adolescents and young adults in the U.S. are increasingly using popular GLP-1 weight-loss drugs alone or in conjunction with metabolic and bariatric surgery (MBS) to manage obesity, according to a study by UT Southwestern Medical Center researchers published in JAMA Pediatrics. Severe obesity among adolescents and young adults has increased substantially over the past two decades, currently affecting about 9% of people between ages 12 and 18. Among adults, the rate of severe obesity increased from 5% to 10%. <Read More> 

New Pharmacy Benefit Manager Rules Shift Focus to Verifiable Accountability – July 17, 2026 - New federal transparency requirements for pharmacy benefit managers (PBMs) are poised to fundamentally change how the industry demonstrates compliance. Rather than simply reporting pricing and rebate data, the new rules require pharmacy benefit operations to prove, at the claim level, how financial outcomes were generated. <Read More> 

Senate Seeks to Audit TRICARE Pharmacy Benefits Program Amid Conflict Concerns – July 16, 2026 – Senate lawmakers are pushing for an independent audit of the Defense Department’s multibillion-dollar TRICARE pharmacy program amid concerns that its longtime contractor, which acts as a pharmacy benefit manager, may also be steering business toward its own pharmacies. The Senate Armed Services Committee’s version of the fiscal 2027 defense policy bill includes a provision that would require the comptroller general to examine how Express Scripts, the contractor that manages the TRICARE pharmacy program while also operating its own mail-order and specialty pharmacies that participate in the network, reimburses its own pharmacies and their competitors. <Read More> 

Pharmacy Closures Disproportionately Burden Minority, Underserved Communities – July 14, 2026 - Analysis of 955 Rite Aid closures found 96.4% of prescriptions transferred to major chains and 68.7% to PBM-affiliated pharmacies, concentrating access within vertically integrated dispensing networks. Independent pharmacies are structurally disincentivized to accept bulk transfers because PBM reimbursement and opaque fees can make incremental volume cash-flow negative and operationally unmanageable. <Read More> 

CVS Caremark Reaches Settlement With FTC Over Insulin Suit – July 14, 2026 – CVS Health’s Caremark has reached a settlement with the Federal Trade Commission requiring notable changes to the pharmacy benefit manager’s business practices, including that Caremark prefer the lowest-cost drugs on its standard formularies and pass through savings negotiated with drugmakers to clients. <Read More> 

340B in the News

D.C. Appeals Court Sides With HHS in 340B Drug Discount Program Rebate Challenge – July 23, 2026 – An appellate court panel ruled Tuesday that drug manufacturers may not impose 340B rebates without approval from the U.S. Department of Health and Human Services (HHS). The ruling (PDF) from the U.S. Court of Appeals for the District of Columbia Circuit upheld a previous decision that Section 340B of the Public Health Service Act does not allow pharmaceutical companies to impose proposed rebate models without HHS Secretary approval. The suit was brought by Novartis, Eli Lilly and Bristol Myers Squibb against HHS Secretary Robert F. Kennedy Jr. and HHS. The decision did not touch on the legality of HHS’ proposed rebate pilot program, which has been embraced by drugmakers and opposed by hospitals. <Read More> 

340B Spending Ballooned to $100B in 2025, Federal Data Shows – July 16, 2026 – Hospitals and outpatient facilities purchased $100 billion worth of drugs in the 340B discount program in 2025, an almost 23% increase from the year prior as regulators look to reform the program. The latest data from the Health and Services Administration, released this week, shows 340B spending has more than doubled since 2021. The vast majority of purchases — almost $80 billion — were made by disproportionate share hospitals last year. Regulators said pricey specialty drugs that treat complex, chronic conditions were also making up a larger portion of 340B spending. Although specialty drugs constituted about 38% of purchases, they accounted for almost 62% of total spending last year, according to the data. <Read More>