Clinical Insights: March 6, 2024

Clinical Insights: April 3, 2024

Clinical Insights: March 20, 2024

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

New Drug/Vaccine Approval

Lenmeldy™ (atidarsagene autotemcel) – New Drug Approval – March 18, 2024 – Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, announced the U.S. Food and Drug Administration (FDA) has approved Lenmeldy™ (atidarsagene autotemcel), formerly known as OTL-200, for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ)—collectively referred to as early-onset—metachromatic leukodystrophy (MLD). <Read More> Rezdiffra™ (resmetirom) Tablets – New Drug Approval – March 14, 2024 – The U.S. Food and Drug Administration approved Rezdiffra™  (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), to be used along with diet and exercise…NASH is a result of the progression of nonalcoholic fatty liver disease where liver inflammation, over time, can lead to liver scarring and liver dysfunction. NASH is often associated with other health problems such as high blood pressure and type 2 diabetes. <Read More> Tevimbra® (tislelizumab-jsgr) Injection – New Drug Approval – March 13, 2024 – BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, announced that the U.S. Food and Drug Administration (FDA) has approved Tevimbra® (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Tevimbra® will be available in the U.S. in the second half of 2024. <Read More>

New Indication/Dosage/Formulation Approval

Xhance® (fluticasone propionate) Nasal Spray – New Label Expansion – March 15, 2024 – Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, announced the U.S. Food and Drug Administration (FDA) has approved Xhance® (fluticasone propionate) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older. <Read More> Breyanzi® (lisocabtagene maraleucel) Suspension for Intravenous Infusion – New Label Expansion – March 14, 2024 – Bristol Myers Squibb (NYSE: BMY) announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). <Read More> Livmarli® (maralixibat) Oral Solution – New Label Expansion – March 13, 2024 – Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) announced that the U.S. Food and Drug Administration (FDA) has approved Livmarli® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients five years of age and older with progressive familial intrahepatic cholestasis (PFIC). Mirum has also submitted an additional supplemental new drug application (sNDA) to introduce a higher concentration formulation of Livmarli®, used during the MARCH study, to enable label expansion for younger patients with PFIC, later this year. Livmarli® is also approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) in the U.S. (three months and older), Europe (two months and older), in Canada and other regions globally. <Read More> Praluent® (alirocumab) Injection – New Label Expansion – March 8, 2024 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the U.S. Food & Drug Administration (FDA) has extended the approval of Praluent® (alirocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to include pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia (HeFH). <Read More> Wegovy® (semaglutide) Injection -New Label Expansion – March 8, 2024 – Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved a label expansion for Wegovy® based on a supplemental New Drug Application (sNDA) for the indication of reducing risks of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with either overweight or obesity and established cardiovascular disease (CVD). <Read More> Brukinsa (zanubrutinib) Capsules – New Label Expansion – March 7, 2024 – The Food and Drug Administration granted accelerated approval to zanubrutinib (Brukinsa®, BeiGene USA, Inc.) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The regimen was evaluated in Study BGB-3111-212 (ROSEWOOD; NCT03332017), an open-label, multicenter, randomized trial that enrolled 217 adult patients with relapsed or refractory FL after at least 2 prior systemic treatments. <Read More> Opdivo® (nivolumab) Injection – New Label Expansion – March 6, 2024 - The Food and Drug Administration approved nivolumab (Opdivo®, Bristol-Myers Squibb Company) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC). Efficacy was evaluated in CHECKMATE-901 (NCT03036098), a randomized, open-label trial enrolling 608 patients with previously untreated unresectable or metastatic UC. Patients were randomized (1:1) to receive either nivolumab in combination with cisplatin and gemcitabine (up to 6 cycles) followed by nivolumab alone for up to two years or cisplatin and gemcitabine (up to 6 cycles). <Read More>  Besponsa (inotuzumab ozogamicin) for Injection – New Label Expansion – March 6, 2024 – The Food and Drug Administration approved inotuzumab ozogamicin (Besponsa®, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). Efficacy was evaluated in a multicenter, single-arm, open-label study in 53 pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor ALL. Two dose levels were evaluated--an initial dose of 1.4 mg/m2/cycle in 12 patients and 1.8 mg/m2/cycle in 41 patients. <Read More>

New Drug Shortage

March 18, 2024

March 15, 2024

March 11, 2024

Updated Drug Shortage

March 19, 2024

March 18, 2024

March 15, 2024

March 13, 2024

March 12, 2024

New Drug Recall and Safety Alerts

Treprostinil Injection by Par Pharmaceuticals – New Voluntary Recall – March 12, 2024 – Endo International plc announced that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product solution. <Read More>

New Generic/Biosimilar Approval and Launch

Jubbonti® (denosumab-bbdz) and Wyost® (denosumab-bbdz) Injections – New Biosimilar Approvals – March 5, 2024 - FDA approved Jubbonti® (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Prolia® (denosumab), and Wyost® (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Xgeva® (denosumab). These products bind to RANKL (receptor activator of nuclear factor kappa beta ligand), blocking its ability to bind to its receptor, a protein called RANK. Inhibition of the RANKL/RANK interaction helps prevent bone cells called osteoclasts from breaking down bone in the body. This is the first interchangeable biosimilar for a RANKL inhibitor. <Read More> Tyenne® (tocilizumab-aazg) Injection – New Biosimilar Approval – March 5, 2024 - Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Tyenne® (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra® (tocilizumab). Tyenne® becomes the first tocilizumab biosimilar with both IV and subcutaneous formulations approved by the FDA. In accordance with its patent settlement agreement with Genentech, Fresenius Kabi has a license to market its tocilizumab products in the U.S. commencing on the license dates, which are confidential. <Read More>

Clinical and Pharmacy News

The Future of Medicare Advantage – March 13, 2024 – The undeniable story of early 2024 for US health insurers has been the sustained economic pressures that Medicare Advantage (MA) payers are experiencing. This was borne out in 2023 year-end financial results, with several MA payers pointing to inpatient and outpatient care utilization being higher than expected, consequently increasing the medical-loss ratio. Looking ahead, the financial pressure on payers could worsen. In its 2025 advance notice for new payment rates, the US Centers for Medicare & Medicaid Services (CMS) notes that there will be an aggregate revenue growth (3.7 percent) when the increase (3.86 percent) driven by the risk score trend is included. Payers’ estimates of this number, however, vary widely. <Read More> Eli Lilly Partners With Amazon Pharmacy for Home Delivery of its Weight Loss, Diabetes and Migraine Drugs – March 13, 2024 – Eli Lilly is partnering with Amazon's pharmacy unit to offer home delivery for diabetes, migraine and obesity medications, including GLP-1 weight loss drug Zepbound™. The drugmaker launched its direct-to-consumer service, LillyDirect, in January to provide consumers access to telehealth and pharmacy services and the ability to get some medications directly from the company via online pharmacies. Lilly selected Amazon Pharmacy to serve as a third-party dispensing provider for LillyDirect Pharmacy Solutions, delivering prescribed Lilly medications directly to a patient’s home, according to an Amazon Pharmacy blog post. <Read More> Oregon Set to Tighten Rules for Pharmacy Benefit Managers. Here’s What They Do – March 10, 2024 – The Legislature passed a bill tightening regulations on companies that serve as pharmacy benefit managers. House Bill 4149 will require the pharmaceutical middlemen to apply for licensing from the state among other new rules. The bipartisan bill passed with overwhelming majorities in both the House and Senate. It now heads to Gov. Tina Kotek for a signature. But what exactly is a pharmacy benefit manager? To help us demystify them, OPB “Weekend Edition” host Lillian Karabaic talked to Crystal Ligori about what exactly they are. <Read More> Prevalence of Self-Reported Hypertension and Antihypertensive Medication Use Among Adults — United States, 2017–2021 – March 7, 2024 – Hypertension, or high blood pressure, is a major risk factor for heart disease and stroke. It increases with age and is highest among non-Hispanic Black or African American persons, men, persons aged ≥65 years, those of lower socioeconomic status, and those who live in the southern United States. Hypertension affects approximately one half of U.S. adults, and approximately one quarter of those persons have their blood pressure under control…Increases in antihypertensive medication use were observed in most sociodemographic groups and in many states. Assessing current trends in hypertension diagnosis and treatment can help guide the development of policies and implementation of interventions to reduce this important risk factor for cardiovascular disease and can aid in addressing health disparities. <Read More> Veklury® Appears to Reduce Risk for Long COVID – March 7, 2024 – Remdesivir (Veklury®, Gilead) appears to reduce the risk for certain long COVID-19 symptoms in people who were hospitalized for COVID-19, according to data presented at CROI 2024. To understand remdesivir’s potential effect on the risk for long COVID, Gilead researchers analyzed HealthVerity data from 52,006 patients. They found using remdesivir, a nucleotide analog prodrug, was associated with a 10% lower risk for any long COVID symptom in patients younger than 65 years (hazard ratio [HR], 0.90; 95% CI, 0.86-0.93) and in those 65 and older (HR, 0.90; 95% CI,0.86-0.95). <Read More> Biden Is Right. The US Generally Pays Double That of Other Countries for Rx Drugs – March 6, 2024 – It’s well documented that Americans pay high prices for health care. But do they pay double or more for prescriptions compared with the rest of the world? President Joe Biden said they did. “If I put you on Air Force One with me, and you have a prescription — no matter what it’s for, minor or major — and I flew you to Toronto or flew to London or flew you to Brazil or flew you anywhere in the world, I can get you that prescription filled for somewhere between 40 to 60% less than it costs here,” Biden said Feb. 22 at a campaign reception in California. <Read More> Clinical Practice Recommendations for Kidney Involvement in Tuberous Sclerosis Complex: A Consensus Statement by the ERKnet Working Group for Autosomal Dominant Structural Kidney Disorders and the ERA Genes & Kidney Working Group – March 5, 2024 – Tuberous sclerosis complex (TSC) is an autosomal dominant disorder characterized by the presence of proliferative lesions throughout the body. Management of TSC is challenging because patients have a multifaceted systemic illness with prominent neurological and developmental impact as well as potentially severe kidney, heart and lung phenotypes; however, every organ system can be involved. Adequate care for patients with TSC requires a coordinated effort involving a multidisciplinary team of clinicians and support staff...Here, we summarize the current evidence and present recommendations for the multidisciplinary management of kidney involvement in TSC. <Read More>

340B in the News

Appeals Court Affirms Arkansas Law Against Drugmakers' 340B Contract Pharmacy Restrictions – March 13, 2024 – A federal appellate court upheld an Arkansas law prohibiting drugmakers from restricting 340B drug discounts for providers using contract pharmacies, potentially setting up other states to pass similar legislation. The ruling was handed down Tuesday by the U.S. Court of Appeals for the Eighth Circuit’s three-judge panel. The judges disagreed with a pharmaceutical industry group’s argument that Arkansas’ 340B Drug Pricing Nondiscrimination Act passed in 2021 is preempted by existing federal law outlining the program, which requires drug manufacturers to sell drugs at a discount to safety-net providers. <Read More>

 

As Urged by the AHA, 8th Circuit Upholds Arkansas Law Protecting 340B Contract Pharmacy Arrangements – March 12, 2024 – The U.S. Court of Appeals for the 8th Circuit March 12 upheld Arkansas’ 340B Drug Pricing Nondiscrimination Act against a constitutional challenge brought by the Pharmaceutical Research and Manufacturers of America, ruling that the Federal Food, Drug, and Cosmetic Act does not preempt the state law. The Arkansas law (Act 1103) prohibits drug company policies that restrict provider access to 340B discounts through community and specialty pharmacy partners. In a friend-of-the-court brief filed in the case last year, AHA argued that the Arkansas statute does not conflict with federal law, but rather supports and complements the 340B program. The court agreed. <Read More>

 


Clinical Insights: July 31, 2026

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> 

Read More

Clinical Insights: July 31, 2026

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> 

Read More

Clinical Insights: July 10, 2026

New Drug/Vaccine Approval

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

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

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

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

New Label Expansions

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

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

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

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

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

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

Capvaxive (pneumococcal 21-valent conjugate vaccine) Injection – New Label Expansion – Patient Population Altered: June 18, 2026 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Capvaxive® (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. <Read More> 

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

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

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

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

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

New Drug Shortage

July 02, 2026

June 30, 2026

June 29, 2026

June 17, 2026

June 15, 2026

Updated Drug Shortage

July 04, 2026

July 02, 2026

July 01, 2026

June 26, 2026

June 25, 2026

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

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

Clinical and Pharmacy News

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

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

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

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

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

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

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

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

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

340B in the News

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

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

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


Read More

Clinical Insights: July 10, 2026

New Drug/Vaccine Approval

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

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

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

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

New Label Expansions

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

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

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

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

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

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

Capvaxive (pneumococcal 21-valent conjugate vaccine) Injection – New Label Expansion – Patient Population Altered: June 18, 2026 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Capvaxive® (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. <Read More> 

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

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

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

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

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

New Drug Shortage

July 02, 2026

June 30, 2026

June 29, 2026

June 17, 2026

June 15, 2026

Updated Drug Shortage

July 04, 2026

July 02, 2026

July 01, 2026

June 26, 2026

June 25, 2026

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

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

Clinical and Pharmacy News

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

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

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

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

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

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

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

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

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

340B in the News

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

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

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


Read More

Clinical Insights: June 10th, 2026

New Drug/Vaccine Approval

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

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

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

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

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

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

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

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

New Label Expansions

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

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

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

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

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

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

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

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

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

New Drug Shortage

June 08, 2026

June 05, 2026

June 04, 2026

June 01, 2026

May 27, 2026

May 21, 2026

May 15, 2026

May 14, 2026

Updated Drug Shortage

June 09, 2026

June 08, 2026

June 05, 2026

June 04, 2026

June 03, 2026

June 01, 2026

May 27, 2026

May 26, 2026

May 22, 2026

May 21, 2026

New Drug Recall and Safety Alerts

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

New Generic/Biosimilar Approval and Launch

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

Clinical and Pharmacy News

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

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

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

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

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

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

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

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

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

340B in the News

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

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

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


Read More

Clinical Insights: June 10th, 2026

New Drug/Vaccine Approval

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

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

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

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

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

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

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

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

New Label Expansions

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

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

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

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

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

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

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

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

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

New Drug Shortage

June 08, 2026

June 05, 2026

June 04, 2026

June 01, 2026

May 27, 2026

May 21, 2026

May 15, 2026

May 14, 2026

Updated Drug Shortage

June 09, 2026

June 08, 2026

June 05, 2026

June 04, 2026

June 03, 2026

June 01, 2026

May 27, 2026

May 26, 2026

May 22, 2026

May 21, 2026

New Drug Recall and Safety Alerts

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

New Generic/Biosimilar Approval and Launch

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

Clinical and Pharmacy News

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

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

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

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

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

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

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

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

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

340B in the News

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

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

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


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

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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