New Drug/Vaccine Approval

Miudella® (copper) Intrauterine System – New Drug Approval – February 24, 2025 - Sebela Women’s Health Inc., a part of Sebela Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) granted approval of Miudella® (copper intrauterine system) for the prevention of pregnancy in females of reproductive potential for up to three years. Miudella® is a next-generation, hormone-free, low-dose copper intrauterine device or IUD, the first to be approved by the FDA in the United States in over 40 years. <Read More> 

Ctexli™ (chenodiol) Tablets – New Drug Approval – February 21, 2025 - The U.S. Food and Drug Administration approved Ctexli™ (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli™ is the first FDA-approved drug to treat CTX, a very rare lipid storage disease. <Read More> 

Romvimza™ (vimseltinib) Capsules – New Drug Approval – February 14, 2025 - The Food and Drug Administration approved vimseltinib (Romvimza™, Deciphera Pharmaceuticals, LLC), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. <Read More> 

Penmenvy™ (meningococcal groups A, B, C, W, and Y vaccine) Lyophilized Powder for Injection – New Vaccine Approval – February 14, 2025 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Penmenvy™ (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of Neisseria meningitidis (A, B, C, W, and Y) which commonly cause invasive meningococcal disease (IMD).  <Read More> 

Vimkunya™ (chikungunya vaccine, recombinant) Injection – New Vaccine Approval – February 14, 2025 - Bavarian Nordic A/S (OMX: BAVA) announced that the U.S. Food and Drug Administration (FDA) has approved Vimkunya™ (Chikungunya Vaccine, Recombinant) for injection, the first virus-like particle (VLP) single-dose chikungunya vaccine in the U.S. for persons 12 years of age and older. The FDA approved Vimkunya™ under Priority Review, based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. <Read More> 

Gomekli™ (mirdametinib) Capsules and Tablets for Oral Suspension – New Drug Approval – February 11, 2025 - The Food and Drug Administration approved mirdametinib (Gomekliä, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. <Read More> 

Emblaveo™ (avibactam and aztreonam) Lyophilized Powder for Injection – New Drug Approval – February 7, 2025 - AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has approved Emblaveo™ (aztreonam and avibactam), as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic. It is approved in combination with metronidazole, for patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI), including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. <Read More> 

Onapgo™ (apomorphine hydrochloride) Subcutaneous Infusion Device - formerly SPN-830 – New Infusion Device Approval – February 4, 2025 - Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) approved Onapgo™ (apomorphine hydrochloride) injection, formerly known as SPN-830, as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). Supernus will make Onapgo™ available in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support at launch. <Read More> 

New Indication/Dosage/Formulation Approval

TNKase® (tenecteplase) Lyophilized Powder for Injection – New Label Expansion – March 3, 2025 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved TNKase® (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS) in adults. This approval of TNKase® marks Genentech’s second approval for stroke, reinforcing the company's long-standing dedication to advancing stroke care as the developer of the only two FDA-approved medicines for AIS, TNKase® and Activase® (alteplase). <Read More> 

Odactra® (house dust mite allergen extract) Sublingual Tablets – New Label Expansion – February 27, 2025 - ALK (ALKB:DC / OMX: ALK B) announced that the US Food and Drug Administration (FDA) has approved ALK’s Odactra® tablet for use in young children with house dust mite (HDM) allergy Odactra® is now indicated to treat HDM-induced allergic rhinitis, with or without conjunctivitis, in children aged five through 11, in addition to patients aged 12 through 65. Odactra® is an allergy immunotherapy (AIT) tablet which dissolves under the tongue and helps patients reduce their allergy symptoms and their reliance on symptomatic medication. <Read More> 

Sublocade® (buprenorphine) Sustained-Release Injection – New Label Expansion – February 24, 2025 - Indivior PLC (Nasdaq/LSE: INDV), a global leader in addiction treatment, announced that the U.S. Food and Drug Administration (FDA) has approved label changes for Sublocade® including a rapid initiation protocol and alternative injection sites, marking a significant advancement in the treatment of moderate to severe opioid use disorder (OUD). Key label changes include:  1) Rapid initiation Protocol: Healthcare providers can now initiate treatment with Sublocade® after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability, 2) Alternative Injection Sites: Sublocade® can now be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering patients and healthcare providers increased flexibility in treatment administration. <Read More> 

Izervay™ (avacincaptad pegol) Intravitreal Solution – New Label Expansion – February 12, 2025 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) announced the U.S. Food and Drug Administration (FDA) approved expanded U.S. Prescribing information for Izervay™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). As a result, Izervay™ is now approved without a limitation on duration of dosing—providing physicians and patients with greater flexibility when managing GA. <Read More> 

Evrysdi® (risdiplam) Powder for Oral Solution and Oral Tablets – New Label Expansion – February 12, 2025 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for an Evrysdi® (risdiplam) tablet for people living with spinal muscular atrophy (SMA). Evrysdi® is the only non-invasive disease-modifying treatment for SMA. The 5 mg Evrysdi® tablet can either be swallowed whole or dispersed in water. <Read More> 

Adcetris® (brentuximab vedotin) Injection – New Label Expansion – February 12, 2025 - Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Adcetris® (brentuximab vedotin) in combination with lenalidomide and a rituximab product for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy. <Read More>  

Susvimo® (ranibizumab) Injection for Intravitreal Use via Ocular Implant – New Label Expansion – February 4, 2025 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes, affecting more than 29 million adults worldwide. Susvimo® is the first and only FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-of-care eye injections. Susvimo® is now available to U.S. retina specialists and their patients with DME. <Read More> 

Ozempic® (semaglutide) Injection – New Label Expansion – January 28, 2025 - Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved Ozempic® to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD). This approval, along with its existing indications for adults with type 2 diabetes to improve glycemic control and to reduce the risk of major cardiovascular events in adults also with known heart disease, establishes Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg as the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class. <Read More> 

Leqembi® (lecanemab-irmb) Injection – New Label Expansion – January 26, 2025 - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four weeks lecanemab-irmb (U.S. brand name: Leqembi®) intravenous (IV) maintenance dosing. Leqembi® is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in the U.S. After 18 months of once every two weeks initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two weeks may be continued. <Read More> 

New Drug Shortage

March 4, 2025

• Amlodipine Besylate; Benazepril Hydrochloride Capsule (Discontinuation)

March 3, 2025

• Acyclovir Ointment (Discontinuation)

• Adalimumab-adbm Injection (Discontinuation)

• Bacitracin Ophthalmic Ointment (Currently In Shortage)

• Dapagliflozin; Saxaglipitin Hydrochloride Tablet (Discontinuation)

February 28, 2025

• Methylphenidate Film, Extended Release (Currently In Shortage)

• Pimecrolimus Cream (Discontinuation)

February 26, 2025

• Tolterodine Tartrate Capsule, Extended Release (Discontinuation)

• Tolterodine Tartrate Tablet (Discontinuation)

February 20, 2025

• Silodosin Capsule (Discontinuation)

Updated Drug Shortage

March 4, 2025

• Cromolyn Sodium Concentrate (Currently In Shortage)

• Flurazepam Hydrochloride Capsule (Currently In Shortage)

March 3, 2025

• Methylphenidate Film, Extended Release (Currently In Shortage)

February 28, 2025

• Cefotaxime Sodium Powder, for Solution (Currently In Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently In Shortage)

February 27, 2025

• Triamcinolone Acetonide Injection (Currently In Shortage)

February 26, 2025

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine

• Saccharate, Dextroamphetamine Sulfate Tablet (Currently In Shortage)

• Bupivacaine Hydrochloride Injection (Currently In Shortage)

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

• Clonazepam Tablet (Currently In Shortage)

• Dobutamine Hydrochloride Injection (Currently In Shortage)

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

• Hydrocortisone Sodium Succinate Injection (Currently In Shortage)

• Hydromorphone Hydrochloride Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Lorazepam Injection (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylprednisolone Acetate Injection (Currently In Shortage)

• Midazolam Hydrochloride Injection (Currently In Shortage)

• Morphine Sulfate Injection (Currently In Shortage)

• Penicillin G Benzathine Injection (Currently In Shortage)

• Quinapril Hydrochloride Tablet (Currently In Shortage)

• Quinapril/Hydrochlorothiazide Tablet (Currently In Shortage)

• Riluzole Oral Suspension (Currently In Shortage)

• Sodium Bicarbonate Injection (Currently In Shortage)

• Sodium Chloride 0.9% Injection (Currently In Shortage)

• Sodium Chloride 23.4% Injection (Currently In Shortage)

• Sterile Water Injection (Currently In Shortage)

New Drug Recall and Safety Alerts

Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags by Central Admixture Pharmacy Services (CAPS) - New Voluntary Recall – February 24, 2025 - Central Admixture Pharmacy is recalling three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags (NDC: 71285-6092-1) to the hospital level. The product is being recalled because CAPS was notified by their raw material supplier of the detection of visible black particulate matter in a single sealed vial of Phenylephrine Hydrochloride. <Read More>

Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq by ICU Medical – New Voluntary Recall – February 13, 2025 – ICU Medical, Inc. is voluntarily recalling one lot each of Potassium Chloride Inj. bags with overwrap labels 10mEq, packaged in cases of Potassium Chloride Inj. 20 mEq, to the user level. ICU medical has received a customer complaint which states that bags of Potassium Chloride Inj. 20 mEq have incorrect overwrap labels which state Potassium Chloride Inj. 10 mEq. <Read More> 

New Generic/Biosimilar Approval and Launch

Ospomyv™ (denosumab-dssb) Injection – New Prolia® Biosimilar Approval – February 16, 2025 - Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Ospomyv™ (denosumab-dssb; SB16; 60 mg pre-filled syringe) and Xbryk™ (denosumab-dssb; SB16; 120 mg vial), biosimilars referencing Prolia® and Xgeva® respectively. In addition, the FDA granted a provisional determination for both Ospomyv™ and Xbryk™'s interchangeability designation. <Read More>

Xbryk™ (denosumab-dssb) Injection – New Xgeva® Biosimilar Approval – February 16, 2025 - Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Ospomyv™ (denosumab-dssb; SB16; 60 mg pre-filled syringe) and Xbryk™ (denosumab-dssb; SB16; 120 mg vial), biosimilars referencing Proliaâ and Xgeva® respectively. In addition, the FDA granted a provisional determination for both Ospomyv™ and Xbryk™'s interchangeability designation. <Read More> 

Merilog™ (insulin aspart-szjj) Injection – New Novolog® Biosimilar Approval – February 14, 2025 - The U.S. Food and Drug Administration approved Merilog™ (insulin-aspart-szjj) as biosimilar to NovoLog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Merilog™, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Merilog™ helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial. <Read More>

Clinical and Pharmacy News

ASTRO Issues Clinical Guideline on Radiation Therapy for Anal Cancer – February 27, 2025 - A new clinical guideline from the American Society for Radiation Oncology (ASTRO) provides guidance on the use of radiation therapy to treat adult patients with primary squamous cell carcinoma of the anal canal and anal margin. The guideline, ASTRO’s first for anal cancer, is published in Practical Radiation Oncology. Although anal cancer is relatively rare compared with colon or rectal cancers, incidence and mortality rates have risen steadily over the past 2 decades, particularly among adults in their 50s. An estimated 10,540 Americans are diagnosed with anal cancer each year, mostly frequently Black men and White women. Overall, women are more than twice as likely as men to develop the disease. <Read More>

Eli Lilly to Expand US Pharma Manufacturing With Four New Sites – February 27, 2025 – Eli Lilly has announced plans to expand its domestic medicine production in the US by establishing four new pharmaceutical manufacturing sites. The move increases the company’s total US capital expansion commitments to more than $50bn since 2020. Three of the four sites will concentrate on active pharmaceutical ingredients manufacturing, aiming to reshore essential small molecule chemical synthesis capabilities and reinforce the company’s supply chain. <Read More> 

How AI Drug Manufacturing is Changing the Game – February 26, 2025 – In drug discovery, companies face a long timeline and steep costs to receive drug approvals. The likelihood of getting to market successfully is less than 10%, according to a 2022 study. “Even small advancements in time-to-lead optimization and improvements in the likelihood of clinical success are important to addressing the thousands of diseases that today have no known treatment or cure,” writes Anthony Costa, NVIDIA director of digital biology, in a HealthTech article. Artificial intelligence helps with process control during drug production and can speed up time to market. Drug discovery and drug manufacturing are both part of pharma AI. <Read More> 

J&J Sues Samsung Bioepis Over ‘Surreptitious’ Breach of Stelaraâ Biosimilar Contract – February 25, 2025 – Johnson & Johnson (J&J) has sued Samsung Bioepis over a ‘concealed plan’ to supply an unnamed health conglomerate with a private label biosimilar version of blockbuster Stelera (ustekinumab). According to the lawsuit filed on 24 February in New Jersey, J&J alleges that Samsung Bioepis has conducted a “surreptitious and deliberate breach” that “threatens irreparable harm to Janssen” in the time since the existing settlement was reached. Developed by subsidiary Janssen, now J&J Innovative Medicine, Stelara has been J&J’s top selling drug since 2019, bringing in peak sales of $11bn in 2023. It is used to treat multiple inflammatory skin and bowel conditions. <Read More> 

How Modern Technology is Shaping the Future of Pharmacy Benefit Management – February 24, 2025 – The pharmacy benefits management (PBM) industry is at a turning point. While 70% of the market still relies on decades-old systems from the big three PBMs, modern technology is quickly transforming the landscape.  ’s cloud-based platforms provide real-time data, advanced analytics and seamless integration into the broader healthcare ecosystem. These innovations enable health plans to respond faster, improve member adherence and optimize benefit management. The shift to modern technology is redefining how organizations manage pharmacy benefits. <Read More> 

FDA Declares End to Semaglutide Shortage; Clock Ticking on Compounded Versions – February 24, 2025 – In the wake of the FDA’s Feb. 21, 2025 announcement declaring an end to the semaglutide (Ozempicâ/Wegovyâ, Novo Nordisk) shortage, stakeholders in the compounding arena offered their take on the agency’s decision and how it may affect patients’ ability to access—and afford—the blockbuster weight-loss medication. The most immediate result of the action will be to dramatically limit the ability of compounding pharmacies to make their own versions of semaglutide. The FDA announcement gave 503A compounders 60 calendar days to stop production of “essentially a copy” of the GLP-1 medications until April 22 this year; 503B compounders were given 90 days, until May 22. <Read More> 

Twenty Drug Interactions You Should Know About – February 21, 2025 – One of the scariest moments of my life happened in 2022 when my father, Tom Donvito, then 75 and unaware of any allergies, experienced an anaphylactic reaction to a hornet sting. After he passed out, my panicked mother called 911, but when the emergency medical technicians arrived, the shot of epinephrine they gave my dad didn’t work – and neither did the second. Why? My dad was on beta blockers, which reduce the effectiveness of epinephrine. Luckily, doctors were able to stabilize him at the hospital. Looking back now, my father doesn’t remember if there was a warning on the safety insert that came with his beta blockers. The EMTs didn’t ask if he was on beta blockers either. <Read More>  

Amazon Joins Forces With Memorial Sloan Kettering for AI-Powered Drug Discovery – February 19, 2025 – Amazon Web Services (AWS) and US-based Memorial Sloan Kettering Cancer Center (MSK) have announced a partnership to leverage artificial intelligence (AI), high-performance computing (HPC), and cloud technology to accelerate cancer research and drug discovery. AWS is one of the world’s largest cloud providers, recently reporting a $107.6bn in segment sales in 2024. The partnership will focus on building a longitudinal data resource for cancer research at MSK, a cancer treatment and research institution based in New York City. <Read More>

How PBMs Limit Access to MS Therapies – February 18, 2025 - The rising cost of specialty medications has long been a challenge for patients with chronic diseases, particularly those living with multiple sclerosis. The Federal Trade Commission’s January 2025 report sheds light on how pharmacy benefit managers are driving up prices, increasing barriers to access, and limiting competition in the specialty drug market. According to the report, pharmacy benefit managers (PBMs) marked up specialty generic drugs by hundreds or even thousands of percent, generating $7.3 billion in revenue over five years. This price inflation disproportionately affects multiple sclerosis (MS) patients, who rely on specialty generics such as Ampyraâ to manage symptoms and maintain their quality of life. However, instead of benefiting from the cost savings generics are supposed to offer, these patients often find their medications out of reach. <Read More> 

Pharmacy Benefit Managers Raised Prices by Over 1,000% on Specialty Drugs – February 14, 2025 – Reporters covering the cost of prescription drugs should be aware of two reports from the Federal Trade Commission on pharmacy benefit managers (PBMs): the first on July 9 and the second on Jan. 14. In the latest report, “Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit Managers,” the FTC staff reported that the three largest PBMs drove up the price of specialty generic drugs for patients with cancer, multiple sclerosis, HIV and pulmonary hypertension by more than 1,000% in some cases and by hundreds of percent in other cases. Together, the nation’s three largest PBMs manage 79% of all prescription drug claims for some 270 million Americans, the FTC staff noted in the July report, “Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies.” <Read More> 

The Remarkable Evolution of HIV/AIDS Treatment – February 14, 2025 – HIV/AIDS was a death sentence. Until LGBT people, people living with HIV, and allies demanded action and pushed the scientific establishment to address the crisis. What followed is nothing short of extraordinary. First came the discovery that AZT (azidothymidine), a drug previously abandoned as a failed cancer treatment, suppressed HIV replication in a petri dish without killing normal cells. Under significant pressure from activists and the public, the FDA fast-tracked testing and review, and approved the drug to treat AIDS in 1987. It worked. <Read More> 

LAAO or DOAC? Mayo Clinic AI Helps Guide Treatment of AFib Patients – February 14, 2025 – Researchers have developed a new artificial intelligence (AI) algorithm that can identify atrial fibrillation (AFib) patients who may benefit from left atrial appendage occlusion (LAAO). The group shared its findings in JACC: Clinical Electrophysiology. “Lifelong oral anticoagulation is recommended for stroke prevention in most patients with AFib, and clinical guidelines recommend direct oral anticoagulant (DOAC) in preference to warfarin in most patients,” wrote first author Che Ngufor, PhD, an AI specialist with Mayo Clinic, and colleagues. “However, oral anticoagulation increases the risk of bleeding and the adherence to lifelong drug therapy is poor, leaving many patients undertreated. Transcatheter LAAO offers an attractive alternative to lifelong drug therapy, but how to select the best candidates for LAAO remains unclear in everyday clinical practice.” <Read More> 

Identifying Weak Planks on the Bridge to Medication Safety – February 12, 2025 – A new review of all 50 state boards of pharmacy regulations by the Institute for Safe Medication Practices has shown that only one or two boards provided detailed guidance for pharmacy drug labeling, ISMP presenters noted at the NASP 2024 Annual Meeting & Expo, in Nashville, Tenn. “Most boards have just generalized, high-level suggestions outside listing requirements for a legal label,” said Jennifer Young, PharmD, BCPS, CSP, a medication safety specialist with ISMP, who noted that an ISMP fellow prepared the pharmacy board review in preparation for the NASP presentation. “I’ve worked in a variety of places in my career, and in each pharmacy, sometimes each store, they had their own preferences and nuances.” <Read More>

340B in the News

The 340B Reimbursement Battle: What Hospitals and Insurers Need to Know – February 12, 2025 – The U.S. Supreme Court’s ruling in American Hospital Association (“AHA”) v. Becerra (2022) sent shockwaves through the 340B drug pricing program when it held that CMS’ reduction of reimbursement for drugs purchased under the 340B program was not permitted by law. The Supreme Court chose not to address potential remedies and remanded the case back to the D.C. District Court for further proceedings on how to correct the underpayments. Instead of vacating the unlawful reimbursement rates, the District Court decided to remand without vacatur, allowing HHS the opportunity to remediate its underpayments. AHA v. Becerra (2023). <Read More>