Clinical Insights: June 4th, 2025

Clinical Insights: August 6th, 2025

Clinical Insights: July 10th, 2025

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

New Drug/Vaccine Approval

Ekterly® (sebetralstat) Tablets - New Drug Approval – July 7, 2025 - KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) announced that the U.S. Food and Drug Administration (FDA) has approved Ekterly® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. Ekterly® is the first and only oral on-demand treatment for HAE. <Read More>

Lynozyfic™ (linvoseltamab-gcpt) Injection - New Drug Approval – July 2, 2025 - The Food and Drug Administration granted accelerated approval to linvoseltamab-gcpt (Lynozyfic™, Regeneron Pharmaceuticals, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. <Read More> 

Zegfrovy® (sunvozertinib) Tablets – New Drug Approval – July 2, 2025 - The Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy®, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. <Read More>

Harliku™ (nitisinone) Tablets - New Drug Approval – June 19, 2025 - Cycle Pharmaceuticals announced that the FDA has approved Harliku (nitisinone) Tablets for the reduction of urine homogentisic acid (HGA) in adult patients with AKU. Launching in July 2025, Harliku™ will be the first and only FDA-approved treatment for AKU, an ultra-rare genetic metabolic disorder in which patients have a buildup of HGA that leads to osteoarthritis, ochronosis, and complications in the kidneys, and heart. <Read More> 

Yeztugo® (lenacapavir) Tablets and Injection - New Drug Approval – June 18, 2025 - Gilead Sciences, Inc. (Nasdaq: GILD)  announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir)—the company’s injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP. Data show that ≥99.9% of participants who received Yeztugo® in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative. <Read More> 

Andembry® (garadacimab-gxii) Injection - New Drug Approval – June 16, 2025 - Melbourne, Australia – CSL (ASX:CSL; USOTC:CSLLY) announces that the U.S. Food and Drug Administration (FDA) has approved Andembry® for immediate launch in the United States. Andembry® helps prevent attacks of hereditary angioedema (HAE). It is the first and only treatment targeting factor XIIa for prophylactic use to provide sustained protection from attacks of HAE in adult and pediatric patients aged 12 years and older. HAE occurs in about 1 in 50,000 people of any ethnic group. <Read More>

Zusduri™ (mitomycin) for Intravesical Solution - formerly UGN-102 - New Drug Approval – June 12, 2025 - UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers,  announced the U.S. Food and Drug Administration (FDA) approved Zusduri™, the first and only FDA-approved medication for adults with recurrent LG-IR-NMIBC. Zusduri™ consists of mitomycin and sterile hydrogel, using UroGen’s proprietary sustained release RTGel® technology. ZUSDURI has been designed for potent tumor ablation. <Read More> 

Ibtroz™ (taletrectinib) Capsules - New Drug Approval – June 11, 2025 - Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced that the U.S. Food and Drug Administration (FDA) has approved Ibtrozi™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). Ibtrozi™ is a highly selective, next-generation oral ROS1 tyrosine kinase inhibitor (TKI) designed to address some of the outstanding challenges of treating ROS1+ NSCLC. It has demonstrated high response rates with durable benefit and intracranial activity and is generally well tolerated, providing a new treatment option for patients with advanced ROS1+ NSCLC. <Read More> 

Enflonsia™ (clesrovimab-cfor) Injection - New Drug Approval – June 9, 2025 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada,  announced the U.S. Food and Drug Administration (FDA) has approved Enflonsia™ (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season. Enflonsia™ is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same 105 mg dose regardless of weight. A typical RSV season usually spans autumn to spring of the next year. <Read More>

Widaplik™ (amlodipine, indapamide and telmisartan) Tablets - formerly GMRx2 - New Drug Approval – June 5, 2025 - George Medicines, a late-stage biopharmaceutical company focused on addressing unmet needs in cardiometabolic disease,  announces that the US Food and Drug Administration (FDA) has approved Widaplik™ (telmisartan, amlodipine and indapamide), formerly known as “GMRx2”, for the treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure. Widaplik™ is a proprietary single pill combination of three medicines: telmisartan, amlodipine and indapamide and is available in three doses: a standard dose and two low doses. It is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Widaplik™, with its three different doses, can deliver the efficacy benefits of a triple mechanism approach early in the treatment pathway with an established safety profile and good tolerability. <Read More> 

Xifyrm™ (meloxicam) Injection - New Drug Approval – June 5, 2025 - Azurity Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved Xifyrm™ (meloxicam injection) an IV non-steroidal anti-inflammatory drug (NSAID) that offers once daily dosing. Xifyrm™  is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. Xifyrm™ provides a non-opioid analgesic in a 30mg/mL vial for IV bolus injection over 15 seconds. Because of delayed onset of analgesia, Xifyrm™ alone is not recommended for use when rapid onset of analgesia is required. <Read More> 

mNEXSPIKE® (COVID-19 Vaccine, mRNA) Injection - New Vaccine Approval – May 30, 2025 – Moderna, Inc. (NASDAQ:MRNA)  announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC). <Read More> 

New Label Expansions

Gamifant® (emapalumab-lzsg) Injection – New Label Expansion – June 28, 2025 - Sobi® (STO: SOBI)  announced that the U.S. Food and Drug Administration (FDA) approved Gamifant® (emapalumab-lzsg) for the treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. <Read More> 

Breyanzi® (lisocabtagene maraleucel) Suspension for Intravenous Infusion – New Label Expansion – June 26, 2025 -  Bristol Myers Squibb (NYSE: BMY)  announced that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi® (lisocabtagene maraleucel; liso-cel) for the treatment of large B cell lymphoma (LBCL) and other lymphomas and Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of multiple myeloma. These label updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that had been in place since each product was initially approved. <Read More>

Datroway® (datopotamab deruxtecan-dlnk) Lyophilized Powder for Injection – New Label Expansion – June 23, 2025 - Datroway® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. <Read More> 

Vizamyl™ (flutemetamol F 18) Injection – New Label Expansion – June 24, 2025 - GE HealthCare (Nasdaq: GEHC)  announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for its positron emission tomography (PET) imaging agent Vizamyl™ (flutemetamol F 18 injection) for beta-amyloid detection. The revised label, effective immediately, expands the indications for use, enables quantitative analysis of Vizamyl™ scans, and removes significant previous limitations such as monitoring patient response to anti-amyloid therapy. <Read More> 

Benlysta® (belimumab) Injection – New Label Expansion – June 24, 2025 - GSK plc (LSE/NYSE: GSK)  announced that the US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of Benlysta® (belimumab), a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody, for subcutaneous injection in patients five years of age and older with active lupus nephritis (LN) who are receiving standard therapy. With this approval, GSK is expanding choices for belimumab treatment, offering pediatric lupus nephritis patients and caregivers a first-of-its-kind subcutaneous option that can be administered at home. The 200 mg/mL autoinjector was approved for pediatric patients with active systemic lupus erythematosus (SLE) in 2024. <Read More> 

Dupixent® (dupilumab) Injection – New Label Expansion – June 18, 2025 - The US Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP). BP primarily affects elderly patients, and is characterized by intense itch, painful blisters, and lesions, as well as reddening of the skin. It can be chronic and relapsing with underlying type 2 inflammation. The blisters and rash can form over much of the body and cause the skin to bleed and break down, resulting in patients being more prone to infection and affecting their daily functioning. Available treatment options are limited and can add to overall disease burden by suppressing a patient’s immune system. <Read More> 

Monjuvi® (tafasitamab-cxix) for Injection – New Label Expansion – June 18, 2025 - Incyte (Nasdaq:INCY)  announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). <Read More> 

Endari® (L-glutamine) Oral Powder – New Label Expansion – June 12, 2025 - Emmaus Life Sciences, Inc. (OTCQB: EMMA), a leader in sickle cell disease treatment, announced  that it has received Food and Drug Administration (FDA) approval for changes to the labelling of Endari® to reflect additional prescribing information derived from post-marketing pharmacokinetic study data submitted by Emmaus. The additional information provides a more comprehensive characterization of Endari®, including confirmation of dosing by body weight, no unwanted accumulation through twice daily dosing, and the ability to administer Endari® with or without food. Endari® is approved in the U.S. and elsewhere to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – June 12, 2025 - 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 Keytruda® (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. <Read More> 

Steqeyma® (ustekinumab-stba) Injection – New Label Expansion – June 12, 2025 - Celltrion, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of Steqeyma® (ustekinumab-stba), a biosimilar to Stelara® (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis (PsO) or psoriatic arthritis (PsA). With this approval, Steqeyma® now offers all dosage forms and strengths of its reference product, providing flexibility to meet physicians' clinical needs while supporting treatment continuity for patients. <Read More>  

Mavyret® (glecaprevir and pibrentasvir) Tablets and Oral Pellets – New Label Expansion – June 10, 2025 - AbbVie (NYSE: ABBV)  announced that the U.S. Food and Drug Administration (FDA) approved a label expansion for Mavyret® (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. It is now approved for the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, Mavyret® is the first and only DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate. <Read More> 

Brukinsa® (zanubrutinib) Capsules and Tablets – New Label Expansion – June 3, 2025 - BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company,  announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of Brukinsa® (zanubrutinib) for all five approved indications. Brukinsa® remains the leader in new chronic lymphocytic leukemia (CLL) patient starts across all lines of therapy in the U.S., and for the first time, has become the overall BTK inhibitor market share leader. <Read More>

Nubeqa® (darolutamide) Tablets – New Label Expansion – June 3, 2025 - Bayer announced  that the U.S. Food and Drug Administration (FDA) has approved its oral androgen receptor inhibitor (ARi) Nubeqa® (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC), which is also known as metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which demonstrated a significant reduction of 46% in the risk of radiographic progression or death (rPFS) for those treated with Nubeqa® plus androgen deprivation therapy (ADT) compared to placebo plus ADT (hazard ratio [HR] 0.54; 95% CI 0.41-0.71; p<0.0001). <Read More> 

Xenoview® (xenon Xe 129 hyperpolarized) for Oral Inhalation – New Label Expansion – June 2, 2025 - Polarean Imaging plc (AIM: POLX) (“Polarean” or the “Company”), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ("MRI") of the lungs, announces that the US Food and Drug Administration (“FDA”) has approved the Company’s Supplemental New Drug Application (“NDA”) to expand the indication of Xenoview®. This approval immediately lowers the minimum patient age from 12 to six years old, significantly broadening access to this technology and expanding Polarean’s total addressable market. <Read More> 

New Drug Shortage

July 8, 2025

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June 18, 2025

Updated Drug Shortage

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June 20, 2025

New Drug Recall and Safety Alerts

Cefazolin for Injection by Sandoz Inc. – New Voluntary Recall – June 27, 2025 - Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial. This single lot is being recalled due to a customer complaint indicating that four (4) Penicillin G Potassium for Injection, USP, 20 million Units labelled vials were incorrectly included in a carton (25 vials per carton) of Cefazolin for Injection, USP 1 gram per vial product. <Read More> 

Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs by Church & Dwight Co., Inc. – New Voluntary Recall – June 6, 2025 - Church & Dwight Co., Inc. is voluntarily recalling all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs to the consumer level. The products are being recalled due to potential microbial contamination identified as fungi in cotton swab components. Swabs found to contain microbial contamination can potentially present a significant risk to the health and safety of consumers including serious and life-threatening blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries. The risk is highest (potentially severe or life-threatening) among children and individuals with compromised immune systems or other underlying medical conditions. To date, no serious adverse events associated with the affected product have been reported. <Read More> 

Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg Amneal Pharmaceutical LLC – New Voluntary Recall – June 4, 2025 - Amneal Pharmaceutical LLC, is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg to the consumer level as the tablets may exhibit black spots on the tablet surface due to microbial contamination. The observance of black spots was reported in a product quality complaint. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition – July 1, 2025 – On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as part of the agencies’ implementation of President Donald Trump’s Executive Order No. 14273, titled “Lowering Drug Prices by Once Again Putting Americans First.” That order instructed the Department of Health and Human Services (HHS) secretary to conduct “joint public listening sessions with the [… DOJ], the Department of Commerce and the [FTC] and issue a report with recommendations to reduce anti-competitive behavior from pharmaceutical manufacturers.” <Read More> 

Major Insurance Changes are Coming for Weight Loss Drugs. Here’s How it Could Affect Patients – July 1, 2025 – Last week, Tara Eacobacci had an appointment with her doctor that was devoted exclusively to the topic of health insurance. A major change to her prescription benefits meant the medication she was using to manage her weight – a treatment that had taken years of trial and error to get right – would no longer be covered by insurance. “I’m completely outraged,” Eacobacci said. “It’s not only causing me stress, but it is making me angry.” Starting Tuesday, CVS Caremark – a major pharmacy benefit manager that serves as a middleman for health insurers, large employers and other payers to manage their prescription drug plans – will stop covering Eli Lilly’s Zepbound, a blockbuster GLP-1 drug that has been approved by the U.S. Food and Drug Administration since November 2023 for chronic weight management in adults with obesity or who are overweight. <Read More> 

Congress Should Remove the Rare Disease Carve-Out From Medicare Drug Price Negotiation, Not Expand It – June 27, 2025 – The Inflation Reduction Act (IRA) of 2022 allowed the Centers for Medicare and Medicaid Services to begin negotiating prices for certain prescription drugs in Medicare. For products to be eligible, they must meet several statutory requirements, including generating more than $200 million in annual Medicare sales (a threshold that increases annually with inflation), being approved by the Food and Drug Administration (FDA) for at least seven years (for small-molecule products) or 11 years (for biologic products), and not yet facing biosimilar or generic competition. In addition, Congress exempted from negotiation any drugs that are approved to treat a single rare disease. <Read More> 

Trump Vows to Cut 'The Best Deal' on Drug Prices. What to Expect – June 26, 2025 – Imagine forking out north of $25,000 for a month's supply of the drug keeping you alive. That's what many hepatitis C patients in the U.S. have had to pay for a 28-day course of Gilead Sciences' (GILD) Epclusa. Canadians paid 35% less for the same treatment, while Australians could buy nearly three months of the drug for roughly the same price…The Trump administration has a plan to change that. Dubbed the "Most Favored Nation" approach, the strategy aims to bring drug prices paid by Americans down to roughly the same level charged by pharma companies in other countries. President Donald Trump said he aims to get Americans "the best deal" on their prescriptions. <Read More> 

Generic Cancer Drugs Used Around the World Fail Quality Tests, Investigation Shows – June 25, 2025 – Vital chemotherapy drugs used around the world have failed quality tests, putting cancer patients in more than 100 countries at risk of ineffective treatments and potentially fatal side effects, an investigation by the Bureau of Investigative Journalism (TBIJ) reveals. The generic drugs in question form the backbone of treatment plans for numerous common cancers — including breast, ovarian, and leukemia. Some drugs contained so little of their key ingredient that pharmacists said giving them to patients would be as good as doing nothing. Other drugs, containing too much of the active ingredient, create the risk of severe organ damage or even death. “Both scenarios are horrendous,” said one pharmacist. “It’s heartbreaking.” <Read More> 

Increasing Biosimilar Use Reflects Changing Practice in Pediatric IBD Care – June 25, 2025 – Infliximab biosimilar initiation among pediatric patients with inflammatory bowel disease (IBD) rose gradually from 1% in 2018 to nearly 42% in 2023, with no consistent differences by age, race, or ethnicity and notable regional variation, according to a retrospective study. The analysis, published in Children, incorporated data from the ImproveCareNow (ICN) Network, a multicenter pediatric IBD quality improvement collaborative. Pediatric IBD is becoming increasingly common, with an incidence of about 10 cases per 100,000 children in the US and Canada and a rising trend. In the US alone, IBD prevalence ranges from 100 to 200 per 100,000 children—amounting to an estimated 70,000 affected children—meaning that most pediatricians are likely to encounter and care for patients with IBD in their practice. <Read More> 

Abbvie Announces Head-to-Head Results Challenging Migraine Treatment Status Quo – June 24, 2025 – For the more than one billion people worldwide living with migraine, the path to effective prevention can feel like an obstacle course. While some migraine patients struggle to find a formal diagnosis, others must navigate a lengthy trial-and-error process with outdated therapies before they can access treatments that provide real relief. Despite migraine ranking as the second leading cause of disability globally, new patients must undergo a “step-therapy” approach, first trying older preventive medications such as anticonvulsants or antidepressants repurposed for migraine before being granted access to newer, more targeted therapies. <Read More> 

HRSA Announces Action to Lower Out-of-Pocket Costs for Life-Saving Medications at Health Centers Nationwide – June 24, 2025 – The Health Resources and Services Administration (HRSA announced new steps to lower out-of-pocket costs for life-saving medications. In alignment with President Trump’s Executive Order “Lowering Drug Prices by Putting Americans First,” HRSA has issued updated award terms requiring HRSA-funded health centers to provide insulin and injectable epinephrine to low-income patients at or below the price paid by the center through the 340B Drug Pricing Program…This new requirement aims to improve access and affordability for two of the most vital medications in emergency and chronic care: insulin, used by millions of Americans to manage diabetes, and injectable epinephrine, critical for the treatment of severe allergic reactions. The high costs of these medications have posed a growing challenge for underserved populations. <Read More> 

Infliximab Biosimilar Switch Due to Flare Risk: Monitoring Patients is Crucial for Pharmacists – June 5, 2025 – Infliximab biosimilars (infliximab-abda and infliximab-dyyb) may delay treatment after patients switch from the reference product, suggesting a possible risk factor for flaring/loss of disease control, according to a study published in the Journal of Pharmacy Technology. Clinicians often treat rheumatic diseases like ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and uveitis, with the anti-tumor necrosis factor agent, infliximab. Over the past few years, the FDA approved 4 infliximab biosimilars. <Read More>

New ACG Guidelines Reflect ‘Tremendous’ Surge in Treatments for Crohn’s, Ulcerative Colitis – June 4, 2025 – The ACG has released new clinical guidelines for the management of ulcerative colitis and Crohn’s disease in adult patients. The guidelines, published in The American Journal of Gastroenterology, reflect numerous advances and new therapeutic options in the management of the two conditions, according to Gary R. Lichtenstein, MD, FACG, lead author of the CD guideline and vice chief of the division of gastroenterology and hepatology, development and philanthropy at Perelman School of Medicine at University of Pennsylvania. <Read More> 

340B in the News

340B Could Have a New Cop on The beat - Hospitals are Worried – July 2, 2025 – The Trump administration wants to move oversight of the controversial drug discount program to the CMS, which has a more aggressive history with 340B than its covered providers would prefer. The Trump administration is pushing significant changes to the healthcare status quo that it says will save money, improve oversight and make the $4.9 trillion sector more efficient. Many of the HHS’ most controversial actions since President Donald Trump took office in January have sparked widespread discussion or been litigated in court as the healthcare industry looks to adjust to the “move fast and break things” mentality of the new Washington. <Read More> 

Judge Rules Against J&J, for HHS and 340B Hospitals in Rebate Model Case – June 27, 2025 – A U.S. District Court for the District of Columbia judge June 27 ruled against Johnson & Johnson and sided with the Department of Health and Human Services and hospitals in a lawsuit brought by J&J challenging the government’s authority to reject J&J’s proposed 340B rebate model. “In sum, based on the plain and unambiguous language of the 340B statute, and supported by its purpose and history, HRSA has the authority to ‘provide’ for discounts, rebates, or both,” Judge Rudolph Contreras wrote. “This conclusion defeats J&J’s claim that HRSA lacked the authority to require prior approval of J&J’s rebate model.” <Read More> 

Cancer Patients are Overmedicated to Enrich Health Systems, Study Claims – June 23, 2025 – Are patients being prescribed more medications not for their health, but to generate profit? A new economic study published in The Journal of Health Economics reveals that cancer patients treated by physicians participating in the 340B Program receive more medications—including those outside clinical guidelines—without improvements in survival. The federal program, named after Section 340B of the Public Health Service Act, was created by Congress in 1992 to support hospitals and clinics serving low-income communities. It allows eligible entities to purchase outpatient drugs at steep discounts and sell at full prices, retaining the difference. The Affordable Care Act expanded eligibility criteria, accelerating the program’s growth. <Read More> 


Clinical Insights: January 15th, 2026

New Drug/Vaccine Approval

Nereus™ (tradipitant) Capsules – New Drug Approval – December 30, 2025 - Vanda – Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) announced that the U.S. Food and Drug Administration (FDA) has approved Nereus™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion. This approval marks the first new pharmacologic treatment in motion sickness in over four decades, representing a significant advancement in the understanding and management of this debilitating physiologic response that affects a substantial portion of the population and has long been recognized as a factor affecting military operational readiness. <Read More>

Yartemlea® (narsoplimab-wuug) Injection - New Drug Approval – December 23, 2025 – Omeros Corporation (NASDAQ: OMER) announced that the U.S. Food and Drug Administration (FDA) has approved Yartemlea® (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), an often-fatal complication of stem-cell transplantation driven by activation of the lectin pathway of complement. Yartemlea® is the first and only approved lectin pathway inhibitor. <Read More>  

Aqvesme™ (mitapivat) Tablets - New Drug Approval – December 23, 2025 – Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Aqvesme™ (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of anemia in adults with alpha- or beta-thalassemia. <Read More> 

Myqorzo™ (aficamten) Tablets - New Drug Approval – December 19, 2025 – Cytokinetics, Incorporated (Nasdaq: CYTK) announced that the U.S. Food and Drug Administration (FDA) has approved Myqorzo™ (aficamten), 5 mg, 10 mg, 15 mg, 20 mg tablets for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. Myqorzo™ is an allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with Myqorzo™ reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction. <Read More>  

Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) Injection - New Drug Approval – December 17, 2025 – Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) approved Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously (SC) administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Rybrevant Faspro™ is approved across all indications of Rybrevant® (amivantamab-vmjw). <Read More> 

New Label Expansions

Cablivi® (caplacizumab-yhdp) Injection – New Label Expansion – December 23, 2025 – The U.S. Food and Drug Administration approved Cablivi® (caplacizumab-yhdp) for injection to treat pediatric patients 12 years and older with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy. Cablivi® was originally approved in 2019 to treat adults with this condition. <Read More> 

Furoscix® (furosemide) Injection – New Label Expansion – December 22, 2025 – MannKind Corporation (Nasdaq: MNKD) announced two business updates—approval of the Furoscix® (furosemide) On-body Infusor for pediatric patients and issuance of additional intellectual property protection for the investigational-stage Furoscix® ReadyFlow™ Autoinjector, which is currently under review by the U.S. FDA. <Read More>  

Wegovy® (semaglutide) Injection and Tablets – New Label Expansion – December 22, 2025 – Wegovy® pill is now available, providing those seeking help with their weight the revolutionary science of GLP-1 medicine in a pill for the first time. This advancement opens new possibilities for the more than 100 million Americans living with obesity. Wegovy® pill was approved on December 22, 2025 and is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off. <Read More>  

ACCRUFeR® (ferric maltol) Capsules – New Label Expansion – December 19, 2025 – Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency, announces that the US Food and Drug Administration (FDA), following a priority review of the clinical supplement, has approved the extension of the indication for ACCRUFeR® (ferric maltol) to include adolescents. ACCRUFeR® is now indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older. <Read More> 

Lunsumio Velo™ (mosunetuzumab-axgb) Injection – New Label Expansion – December 19, 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 CD20xCD3 bispecific Lunsumio Velo™ (mosunetuzumab-axgb), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the Phase I/II GO29781 study. <Read More> 

Jascayd® (nerandomilast) Tablets – New Label Expansion – December 19, 2025 – Boehringer Ingelheim’s Jascayd® (nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of progressive pulmonary fibrosis (PPF) in adults. This represents a new treatment option in the U.S. for this debilitating lung condition, with Jascayd® being the first and only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved in this indication. <Read More> 

Rubraca® (rucaparib) Tablets – New Label Expansion – December 17, 2025 - The Food and Drug Administration (FDA) approved rucaparib (Rubraca®, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic (CDx). Rucaparib was granted accelerated approval in 2020 for a similar indication. <Read More> 

New Drug Shortage

January 12, 2026

January 09, 2026

January 08, 2026

January 06, 2026

January 05, 2026

Updated Drug Shortage

January 09, 2026

January 08, 2026

January 06, 2026

January 05, 2026

January 04, 2026

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Boncresa™ (denosumab-mobz) Injection - New Prolia® Biosimilar Approval – December 19, 2025 – Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for Boncresa™ (denosumab-mobz), a biosimilar referencing Prolia®. <Read More> 

Oziltus™ (denosumab-mobz) Injection - New Xvega® Biosimilar Approval – December 19, 2025 – Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for…Oziltus™ (denosumab-mobz), a biosimilar referencing Xgeva®. <Read More> 

Nufymco® (ranibizumab-leyk) Injection - New Lucentis® Biosimilar Approval – December 18, 2025 – Formycon AG (FWB: FYB, Prime Standard, “Formycon”) and Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) has approved Nufymco® (ranibizumab-leyk), an interchangeable biosimilar to Lucentis®. <Read More> 

Clinical and Pharmacy News

Asthma Management Clinical Practice Guideline Revisions Include Single-Inhaler Approach – January 13, 2026 – The Clinical Practice Guideline for the Primary Care Management of Asthma from the Department of Veterans Affairs and Department of Defense recommends using newer, fast-onset medications and one inhaler rather than two for maintenance and rescue needs. These combination medications are called Single Maintenance and Reliever Therapy, or SMART or MART, explained Maj. (Dr.) Jonathan Schroeder. He is chief of pediatric pulmonology and medical director of the Cystic Fibrosis Center at Brooke Army Medical Center in San Antonio, Texas. <Read More> 

National Pharmacy Benefit Manager Implements Direct-to-Consumer Model – January 12, 2026 – As the healthcare landscape rapidly evolves, the direct-to-consumer (DTC) model is transforming how Americans access prescription medications, putting price transparency, convenience and control directly into patients’ hands, while also lowering costs patients pay for prescription medications. Recognizing this shift, a major Pharmacy Benefit Manager (PBM) has taken a step by launching its own DTC Program Opportunity for network pharmacies. This initiative enables pharmacies to offer upfront, competitive DTC pricing at the point of sale, empowering patients to make informed choices about their healthcare while streamlining the prescription process for providers. By embracing this patient-centric model, the PBM is responding to changing consumer expectations. <Read More> 

What to Expect in US Healthcare in 2026 and Beyond – January 12, 2026 – The US healthcare system continues to face considerable financial strain, although there are pockets of opportunity. Industry EBITDA as a percentage of national health expenditures (NHE) fell from 11.2 percent in 2019 to 8.9 percent in 2024. In 2027, the picture is expected to worsen slightly, with industry EBITDA as a percentage of NHE expected to drop to 8.7 percent. <Read More> 

Industry Voices—Relational Technology: How FQHCs Bridge Specialty Care’s Missed Connections – January 9, 2026 – The challenge in community health isn’t just providing access to specialists; it’s also bridging the gap between primary and specialty care. Technology promises to transform clinical practice, but needs a human connection to produce transformative outcomes. To succeed at their mission, community health centers must embrace what I call relational technology—not tools but relationship multipliers that strengthen the bond between patient and provider. For the over 32 million federally qualified health center (FQHC) clients, largely from underserved populations, a referral to a specialist is often not a solution but rather the start of a confusing journey. <Read More> 

FDA Grants First Priority Voucher Approval to Augmentin XR™ – January 9, 2026 – The FDA approved Augmentin XR™ (amoxicillin-clavulanate potassium) to be manufactured by USAntibiotics under the Commissioner’s National Priority Voucher (CNPV) pilot program, marking the first time since the program was announced in June that a drug has been approved though the new review pathway. Augmentin XR™ is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the beta-lactamase inhibitor clavulanate. The approval was completed in just two months, which the agency said “represent[s] a major reduction of the review timeline.” <Read More> 

CMS Proposes GLOBE and GUARD Drug Pricing Models to Reduce Medicare Costs – January 8, 2026 – CMS has proposed two mandatory Medicare drug pricing models: the GLOBE Model (for Part B drugs) and the GUARD Model (for Part D drugs). Both models would link Medicare drug rebate calculations to international pricing benchmarks from “economically comparable” countries. If finalized, the GLOBE and GUARD Models would create new and potentially significant rebate obligations for drug manufacturers. <Read More> 

WHO Releases Updated Recommendations on HIV Clinical Management – January 7, 2026 – The World Health Organization (WHO) has released updated recommendations on HIV clinical management providing new and revised guidance on antiretroviral therapy, management of vertical HIV transmission, and tuberculosis (TB) prevention for people living with HIV. These recommendations support an evidence-based, cost-effective approach to improving treatment outcomes, reducing HIV-related mortality and accelerating progress towards ending AIDS as a public health threat. <Read More> 

GLP-1 Coverage Expansion Under Medicare: What Digital Health Companies Need to Know – January 7, 2026 – The Trump administration has announced a pricing initiative designed to reduce the cost of glucagon-like peptide-1 (GLP-1) drug products for certain Medicare enrollees. This policy represents a significant departure from the administration’s prior position that Medicare and Medicaid would not cover anti-obesity medications, including GLP-1 products. The change is expected to influence market dynamics for both consumers and industry stakeholders, particularly telehealth companies. Telehealth providers and other digital health companies that have relied on lower-priced GLP-1 offerings as a competitive differentiator may face new challenges as Medicare pricing becomes more attractive to patients, especially as new products enter the market, such as a recent US Food and Drug Administration (FDA) approved oral GLP 1 pill. <Read More> 

Medical Experts Warn Federal Rollback of Childhood Vaccine Schedule Puts Children at Risk – January 7, 2026 – Medical and public health leaders expressed alarm after federal health officials announced sweeping changes to the U.S. childhood immunization schedule, an unprecedented move experts warn could accelerate the spread of vaccine-preventable diseases and dismantle decades of evidence-based vaccine policy. The Jan. 5 announcement by the CDC and the Department of Health and Human Services to revise long-standing childhood vaccine recommendations was finalized without public comment, marking a sharp departure from the transparent, science-driven process that has historically governed U.S. immunization guidance. <Read More> 

The 2026 Pharma Reset: How Industry Giants Are Navigating a New Era of Federal Price Controls – January 2, 2026 – January 1 marked the official commencement of the first-ever "Maximum Fair Prices" (MFPs) for ten of the most widely used drugs in the Medicare program, a direct result of the Inflation Reduction Act’s (IRA) negotiation provisions. This milestone represents a fundamental shift in the federal government’s role in drug pricing, moving from a passive payer to an active negotiator, and signaling the end of an era where manufacturers held unilateral pricing power for the duration of a drug's patent life. <Read More> 

340B in the News

340B Rebate Pilot Remains on Hold in Win for Hospitals – January 8, 2026 – The First Circuit Court of Appeals upheld the halt of the 340B rebate pilot on Wednesday, meaning the contentious payment experiment remains on hold as hospitals’ lawsuit seeking to block it progresses. Judges called the district court’s decision to pause the pilot “careful and thorough” in their Jan. 7 order, while noting that the Trump administration had failed to convince them it would succeed on the merits of its case. <Read More> 

Read More

Clinical Insights: January 15th, 2026

New Drug/Vaccine Approval

Nereus™ (tradipitant) Capsules – New Drug Approval – December 30, 2025 - Vanda – Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) announced that the U.S. Food and Drug Administration (FDA) has approved Nereus™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion. This approval marks the first new pharmacologic treatment in motion sickness in over four decades, representing a significant advancement in the understanding and management of this debilitating physiologic response that affects a substantial portion of the population and has long been recognized as a factor affecting military operational readiness. <Read More>

Yartemlea® (narsoplimab-wuug) Injection - New Drug Approval – December 23, 2025 – Omeros Corporation (NASDAQ: OMER) announced that the U.S. Food and Drug Administration (FDA) has approved Yartemlea® (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), an often-fatal complication of stem-cell transplantation driven by activation of the lectin pathway of complement. Yartemlea® is the first and only approved lectin pathway inhibitor. <Read More>  

Aqvesme™ (mitapivat) Tablets - New Drug Approval – December 23, 2025 – Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Aqvesme™ (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of anemia in adults with alpha- or beta-thalassemia. <Read More> 

Myqorzo™ (aficamten) Tablets - New Drug Approval – December 19, 2025 – Cytokinetics, Incorporated (Nasdaq: CYTK) announced that the U.S. Food and Drug Administration (FDA) has approved Myqorzo™ (aficamten), 5 mg, 10 mg, 15 mg, 20 mg tablets for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. Myqorzo™ is an allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with Myqorzo™ reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction. <Read More>  

Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) Injection - New Drug Approval – December 17, 2025 – Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) approved Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously (SC) administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Rybrevant Faspro™ is approved across all indications of Rybrevant® (amivantamab-vmjw). <Read More> 

New Label Expansions

Cablivi® (caplacizumab-yhdp) Injection – New Label Expansion – December 23, 2025 – The U.S. Food and Drug Administration approved Cablivi® (caplacizumab-yhdp) for injection to treat pediatric patients 12 years and older with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy. Cablivi® was originally approved in 2019 to treat adults with this condition. <Read More> 

Furoscix® (furosemide) Injection – New Label Expansion – December 22, 2025 – MannKind Corporation (Nasdaq: MNKD) announced two business updates—approval of the Furoscix® (furosemide) On-body Infusor for pediatric patients and issuance of additional intellectual property protection for the investigational-stage Furoscix® ReadyFlow™ Autoinjector, which is currently under review by the U.S. FDA. <Read More>  

Wegovy® (semaglutide) Injection and Tablets – New Label Expansion – December 22, 2025 – Wegovy® pill is now available, providing those seeking help with their weight the revolutionary science of GLP-1 medicine in a pill for the first time. This advancement opens new possibilities for the more than 100 million Americans living with obesity. Wegovy® pill was approved on December 22, 2025 and is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off. <Read More>  

ACCRUFeR® (ferric maltol) Capsules – New Label Expansion – December 19, 2025 – Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency, announces that the US Food and Drug Administration (FDA), following a priority review of the clinical supplement, has approved the extension of the indication for ACCRUFeR® (ferric maltol) to include adolescents. ACCRUFeR® is now indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older. <Read More> 

Lunsumio Velo™ (mosunetuzumab-axgb) Injection – New Label Expansion – December 19, 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 CD20xCD3 bispecific Lunsumio Velo™ (mosunetuzumab-axgb), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the Phase I/II GO29781 study. <Read More> 

Jascayd® (nerandomilast) Tablets – New Label Expansion – December 19, 2025 – Boehringer Ingelheim’s Jascayd® (nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of progressive pulmonary fibrosis (PPF) in adults. This represents a new treatment option in the U.S. for this debilitating lung condition, with Jascayd® being the first and only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved in this indication. <Read More> 

Rubraca® (rucaparib) Tablets – New Label Expansion – December 17, 2025 - The Food and Drug Administration (FDA) approved rucaparib (Rubraca®, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic (CDx). Rucaparib was granted accelerated approval in 2020 for a similar indication. <Read More> 

New Drug Shortage

January 12, 2026

January 09, 2026

January 08, 2026

January 06, 2026

January 05, 2026

Updated Drug Shortage

January 09, 2026

January 08, 2026

January 06, 2026

January 05, 2026

January 04, 2026

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Boncresa™ (denosumab-mobz) Injection - New Prolia® Biosimilar Approval – December 19, 2025 – Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for Boncresa™ (denosumab-mobz), a biosimilar referencing Prolia®. <Read More> 

Oziltus™ (denosumab-mobz) Injection - New Xvega® Biosimilar Approval – December 19, 2025 – Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for…Oziltus™ (denosumab-mobz), a biosimilar referencing Xgeva®. <Read More> 

Nufymco® (ranibizumab-leyk) Injection - New Lucentis® Biosimilar Approval – December 18, 2025 – Formycon AG (FWB: FYB, Prime Standard, “Formycon”) and Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) has approved Nufymco® (ranibizumab-leyk), an interchangeable biosimilar to Lucentis®. <Read More> 

Clinical and Pharmacy News

Asthma Management Clinical Practice Guideline Revisions Include Single-Inhaler Approach – January 13, 2026 – The Clinical Practice Guideline for the Primary Care Management of Asthma from the Department of Veterans Affairs and Department of Defense recommends using newer, fast-onset medications and one inhaler rather than two for maintenance and rescue needs. These combination medications are called Single Maintenance and Reliever Therapy, or SMART or MART, explained Maj. (Dr.) Jonathan Schroeder. He is chief of pediatric pulmonology and medical director of the Cystic Fibrosis Center at Brooke Army Medical Center in San Antonio, Texas. <Read More> 

National Pharmacy Benefit Manager Implements Direct-to-Consumer Model – January 12, 2026 – As the healthcare landscape rapidly evolves, the direct-to-consumer (DTC) model is transforming how Americans access prescription medications, putting price transparency, convenience and control directly into patients’ hands, while also lowering costs patients pay for prescription medications. Recognizing this shift, a major Pharmacy Benefit Manager (PBM) has taken a step by launching its own DTC Program Opportunity for network pharmacies. This initiative enables pharmacies to offer upfront, competitive DTC pricing at the point of sale, empowering patients to make informed choices about their healthcare while streamlining the prescription process for providers. By embracing this patient-centric model, the PBM is responding to changing consumer expectations. <Read More> 

What to Expect in US Healthcare in 2026 and Beyond – January 12, 2026 – The US healthcare system continues to face considerable financial strain, although there are pockets of opportunity. Industry EBITDA as a percentage of national health expenditures (NHE) fell from 11.2 percent in 2019 to 8.9 percent in 2024. In 2027, the picture is expected to worsen slightly, with industry EBITDA as a percentage of NHE expected to drop to 8.7 percent. <Read More> 

Industry Voices—Relational Technology: How FQHCs Bridge Specialty Care’s Missed Connections – January 9, 2026 – The challenge in community health isn’t just providing access to specialists; it’s also bridging the gap between primary and specialty care. Technology promises to transform clinical practice, but needs a human connection to produce transformative outcomes. To succeed at their mission, community health centers must embrace what I call relational technology—not tools but relationship multipliers that strengthen the bond between patient and provider. For the over 32 million federally qualified health center (FQHC) clients, largely from underserved populations, a referral to a specialist is often not a solution but rather the start of a confusing journey. <Read More> 

FDA Grants First Priority Voucher Approval to Augmentin XR™ – January 9, 2026 – The FDA approved Augmentin XR™ (amoxicillin-clavulanate potassium) to be manufactured by USAntibiotics under the Commissioner’s National Priority Voucher (CNPV) pilot program, marking the first time since the program was announced in June that a drug has been approved though the new review pathway. Augmentin XR™ is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the beta-lactamase inhibitor clavulanate. The approval was completed in just two months, which the agency said “represent[s] a major reduction of the review timeline.” <Read More> 

CMS Proposes GLOBE and GUARD Drug Pricing Models to Reduce Medicare Costs – January 8, 2026 – CMS has proposed two mandatory Medicare drug pricing models: the GLOBE Model (for Part B drugs) and the GUARD Model (for Part D drugs). Both models would link Medicare drug rebate calculations to international pricing benchmarks from “economically comparable” countries. If finalized, the GLOBE and GUARD Models would create new and potentially significant rebate obligations for drug manufacturers. <Read More> 

WHO Releases Updated Recommendations on HIV Clinical Management – January 7, 2026 – The World Health Organization (WHO) has released updated recommendations on HIV clinical management providing new and revised guidance on antiretroviral therapy, management of vertical HIV transmission, and tuberculosis (TB) prevention for people living with HIV. These recommendations support an evidence-based, cost-effective approach to improving treatment outcomes, reducing HIV-related mortality and accelerating progress towards ending AIDS as a public health threat. <Read More> 

GLP-1 Coverage Expansion Under Medicare: What Digital Health Companies Need to Know – January 7, 2026 – The Trump administration has announced a pricing initiative designed to reduce the cost of glucagon-like peptide-1 (GLP-1) drug products for certain Medicare enrollees. This policy represents a significant departure from the administration’s prior position that Medicare and Medicaid would not cover anti-obesity medications, including GLP-1 products. The change is expected to influence market dynamics for both consumers and industry stakeholders, particularly telehealth companies. Telehealth providers and other digital health companies that have relied on lower-priced GLP-1 offerings as a competitive differentiator may face new challenges as Medicare pricing becomes more attractive to patients, especially as new products enter the market, such as a recent US Food and Drug Administration (FDA) approved oral GLP 1 pill. <Read More> 

Medical Experts Warn Federal Rollback of Childhood Vaccine Schedule Puts Children at Risk – January 7, 2026 – Medical and public health leaders expressed alarm after federal health officials announced sweeping changes to the U.S. childhood immunization schedule, an unprecedented move experts warn could accelerate the spread of vaccine-preventable diseases and dismantle decades of evidence-based vaccine policy. The Jan. 5 announcement by the CDC and the Department of Health and Human Services to revise long-standing childhood vaccine recommendations was finalized without public comment, marking a sharp departure from the transparent, science-driven process that has historically governed U.S. immunization guidance. <Read More> 

The 2026 Pharma Reset: How Industry Giants Are Navigating a New Era of Federal Price Controls – January 2, 2026 – January 1 marked the official commencement of the first-ever "Maximum Fair Prices" (MFPs) for ten of the most widely used drugs in the Medicare program, a direct result of the Inflation Reduction Act’s (IRA) negotiation provisions. This milestone represents a fundamental shift in the federal government’s role in drug pricing, moving from a passive payer to an active negotiator, and signaling the end of an era where manufacturers held unilateral pricing power for the duration of a drug's patent life. <Read More> 

340B in the News

340B Rebate Pilot Remains on Hold in Win for Hospitals – January 8, 2026 – The First Circuit Court of Appeals upheld the halt of the 340B rebate pilot on Wednesday, meaning the contentious payment experiment remains on hold as hospitals’ lawsuit seeking to block it progresses. Judges called the district court’s decision to pause the pilot “careful and thorough” in their Jan. 7 order, while noting that the Trump administration had failed to convince them it would succeed on the merits of its case. <Read More> 

Read More

Clinical Insights: January 15th, 2026

New Drug/Vaccine Approval

Nereus™ (tradipitant) Capsules – New Drug Approval – December 30, 2025 - Vanda – Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) announced that the U.S. Food and Drug Administration (FDA) has approved Nereus™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion. This approval marks the first new pharmacologic treatment in motion sickness in over four decades, representing a significant advancement in the understanding and management of this debilitating physiologic response that affects a substantial portion of the population and has long been recognized as a factor affecting military operational readiness. <Read More>

Yartemlea® (narsoplimab-wuug) Injection - New Drug Approval – December 23, 2025 – Omeros Corporation (NASDAQ: OMER) announced that the U.S. Food and Drug Administration (FDA) has approved Yartemlea® (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), an often-fatal complication of stem-cell transplantation driven by activation of the lectin pathway of complement. Yartemlea® is the first and only approved lectin pathway inhibitor. <Read More>  

Aqvesme™ (mitapivat) Tablets - New Drug Approval – December 23, 2025 – Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Aqvesme™ (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of anemia in adults with alpha- or beta-thalassemia. <Read More> 

Myqorzo™ (aficamten) Tablets - New Drug Approval – December 19, 2025 – Cytokinetics, Incorporated (Nasdaq: CYTK) announced that the U.S. Food and Drug Administration (FDA) has approved Myqorzo™ (aficamten), 5 mg, 10 mg, 15 mg, 20 mg tablets for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. Myqorzo™ is an allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with Myqorzo™ reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction. <Read More>  

Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) Injection - New Drug Approval – December 17, 2025 – Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) approved Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously (SC) administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Rybrevant Faspro™ is approved across all indications of Rybrevant® (amivantamab-vmjw). <Read More> 

New Label Expansions

Cablivi® (caplacizumab-yhdp) Injection – New Label Expansion – December 23, 2025 – The U.S. Food and Drug Administration approved Cablivi® (caplacizumab-yhdp) for injection to treat pediatric patients 12 years and older with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy. Cablivi® was originally approved in 2019 to treat adults with this condition. <Read More> 

Furoscix® (furosemide) Injection – New Label Expansion – December 22, 2025 – MannKind Corporation (Nasdaq: MNKD) announced two business updates—approval of the Furoscix® (furosemide) On-body Infusor for pediatric patients and issuance of additional intellectual property protection for the investigational-stage Furoscix® ReadyFlow™ Autoinjector, which is currently under review by the U.S. FDA. <Read More>  

Wegovy® (semaglutide) Injection and Tablets – New Label Expansion – December 22, 2025 – Wegovy® pill is now available, providing those seeking help with their weight the revolutionary science of GLP-1 medicine in a pill for the first time. This advancement opens new possibilities for the more than 100 million Americans living with obesity. Wegovy® pill was approved on December 22, 2025 and is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off. <Read More>  

ACCRUFeR® (ferric maltol) Capsules – New Label Expansion – December 19, 2025 – Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency, announces that the US Food and Drug Administration (FDA), following a priority review of the clinical supplement, has approved the extension of the indication for ACCRUFeR® (ferric maltol) to include adolescents. ACCRUFeR® is now indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older. <Read More> 

Lunsumio Velo™ (mosunetuzumab-axgb) Injection – New Label Expansion – December 19, 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 CD20xCD3 bispecific Lunsumio Velo™ (mosunetuzumab-axgb), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the Phase I/II GO29781 study. <Read More> 

Jascayd® (nerandomilast) Tablets – New Label Expansion – December 19, 2025 – Boehringer Ingelheim’s Jascayd® (nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of progressive pulmonary fibrosis (PPF) in adults. This represents a new treatment option in the U.S. for this debilitating lung condition, with Jascayd® being the first and only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved in this indication. <Read More> 

Rubraca® (rucaparib) Tablets – New Label Expansion – December 17, 2025 - The Food and Drug Administration (FDA) approved rucaparib (Rubraca®, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic (CDx). Rucaparib was granted accelerated approval in 2020 for a similar indication. <Read More> 

New Drug Shortage

January 12, 2026

January 09, 2026

January 08, 2026

January 06, 2026

January 05, 2026

Updated Drug Shortage

January 09, 2026

January 08, 2026

January 06, 2026

January 05, 2026

January 04, 2026

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Boncresa™ (denosumab-mobz) Injection - New Prolia® Biosimilar Approval – December 19, 2025 – Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for Boncresa™ (denosumab-mobz), a biosimilar referencing Prolia®. <Read More> 

Oziltus™ (denosumab-mobz) Injection - New Xvega® Biosimilar Approval – December 19, 2025 – Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for…Oziltus™ (denosumab-mobz), a biosimilar referencing Xgeva®. <Read More> 

Nufymco® (ranibizumab-leyk) Injection - New Lucentis® Biosimilar Approval – December 18, 2025 – Formycon AG (FWB: FYB, Prime Standard, “Formycon”) and Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) has approved Nufymco® (ranibizumab-leyk), an interchangeable biosimilar to Lucentis®. <Read More> 

Clinical and Pharmacy News

Asthma Management Clinical Practice Guideline Revisions Include Single-Inhaler Approach – January 13, 2026 – The Clinical Practice Guideline for the Primary Care Management of Asthma from the Department of Veterans Affairs and Department of Defense recommends using newer, fast-onset medications and one inhaler rather than two for maintenance and rescue needs. These combination medications are called Single Maintenance and Reliever Therapy, or SMART or MART, explained Maj. (Dr.) Jonathan Schroeder. He is chief of pediatric pulmonology and medical director of the Cystic Fibrosis Center at Brooke Army Medical Center in San Antonio, Texas. <Read More> 

National Pharmacy Benefit Manager Implements Direct-to-Consumer Model – January 12, 2026 – As the healthcare landscape rapidly evolves, the direct-to-consumer (DTC) model is transforming how Americans access prescription medications, putting price transparency, convenience and control directly into patients’ hands, while also lowering costs patients pay for prescription medications. Recognizing this shift, a major Pharmacy Benefit Manager (PBM) has taken a step by launching its own DTC Program Opportunity for network pharmacies. This initiative enables pharmacies to offer upfront, competitive DTC pricing at the point of sale, empowering patients to make informed choices about their healthcare while streamlining the prescription process for providers. By embracing this patient-centric model, the PBM is responding to changing consumer expectations. <Read More> 

What to Expect in US Healthcare in 2026 and Beyond – January 12, 2026 – The US healthcare system continues to face considerable financial strain, although there are pockets of opportunity. Industry EBITDA as a percentage of national health expenditures (NHE) fell from 11.2 percent in 2019 to 8.9 percent in 2024. In 2027, the picture is expected to worsen slightly, with industry EBITDA as a percentage of NHE expected to drop to 8.7 percent. <Read More> 

Industry Voices—Relational Technology: How FQHCs Bridge Specialty Care’s Missed Connections – January 9, 2026 – The challenge in community health isn’t just providing access to specialists; it’s also bridging the gap between primary and specialty care. Technology promises to transform clinical practice, but needs a human connection to produce transformative outcomes. To succeed at their mission, community health centers must embrace what I call relational technology—not tools but relationship multipliers that strengthen the bond between patient and provider. For the over 32 million federally qualified health center (FQHC) clients, largely from underserved populations, a referral to a specialist is often not a solution but rather the start of a confusing journey. <Read More> 

FDA Grants First Priority Voucher Approval to Augmentin XR™ – January 9, 2026 – The FDA approved Augmentin XR™ (amoxicillin-clavulanate potassium) to be manufactured by USAntibiotics under the Commissioner’s National Priority Voucher (CNPV) pilot program, marking the first time since the program was announced in June that a drug has been approved though the new review pathway. Augmentin XR™ is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the beta-lactamase inhibitor clavulanate. The approval was completed in just two months, which the agency said “represent[s] a major reduction of the review timeline.” <Read More> 

CMS Proposes GLOBE and GUARD Drug Pricing Models to Reduce Medicare Costs – January 8, 2026 – CMS has proposed two mandatory Medicare drug pricing models: the GLOBE Model (for Part B drugs) and the GUARD Model (for Part D drugs). Both models would link Medicare drug rebate calculations to international pricing benchmarks from “economically comparable” countries. If finalized, the GLOBE and GUARD Models would create new and potentially significant rebate obligations for drug manufacturers. <Read More> 

WHO Releases Updated Recommendations on HIV Clinical Management – January 7, 2026 – The World Health Organization (WHO) has released updated recommendations on HIV clinical management providing new and revised guidance on antiretroviral therapy, management of vertical HIV transmission, and tuberculosis (TB) prevention for people living with HIV. These recommendations support an evidence-based, cost-effective approach to improving treatment outcomes, reducing HIV-related mortality and accelerating progress towards ending AIDS as a public health threat. <Read More> 

GLP-1 Coverage Expansion Under Medicare: What Digital Health Companies Need to Know – January 7, 2026 – The Trump administration has announced a pricing initiative designed to reduce the cost of glucagon-like peptide-1 (GLP-1) drug products for certain Medicare enrollees. This policy represents a significant departure from the administration’s prior position that Medicare and Medicaid would not cover anti-obesity medications, including GLP-1 products. The change is expected to influence market dynamics for both consumers and industry stakeholders, particularly telehealth companies. Telehealth providers and other digital health companies that have relied on lower-priced GLP-1 offerings as a competitive differentiator may face new challenges as Medicare pricing becomes more attractive to patients, especially as new products enter the market, such as a recent US Food and Drug Administration (FDA) approved oral GLP 1 pill. <Read More> 

Medical Experts Warn Federal Rollback of Childhood Vaccine Schedule Puts Children at Risk – January 7, 2026 – Medical and public health leaders expressed alarm after federal health officials announced sweeping changes to the U.S. childhood immunization schedule, an unprecedented move experts warn could accelerate the spread of vaccine-preventable diseases and dismantle decades of evidence-based vaccine policy. The Jan. 5 announcement by the CDC and the Department of Health and Human Services to revise long-standing childhood vaccine recommendations was finalized without public comment, marking a sharp departure from the transparent, science-driven process that has historically governed U.S. immunization guidance. <Read More> 

The 2026 Pharma Reset: How Industry Giants Are Navigating a New Era of Federal Price Controls – January 2, 2026 – January 1 marked the official commencement of the first-ever "Maximum Fair Prices" (MFPs) for ten of the most widely used drugs in the Medicare program, a direct result of the Inflation Reduction Act’s (IRA) negotiation provisions. This milestone represents a fundamental shift in the federal government’s role in drug pricing, moving from a passive payer to an active negotiator, and signaling the end of an era where manufacturers held unilateral pricing power for the duration of a drug's patent life. <Read More> 

340B in the News

340B Rebate Pilot Remains on Hold in Win for Hospitals – January 8, 2026 – The First Circuit Court of Appeals upheld the halt of the 340B rebate pilot on Wednesday, meaning the contentious payment experiment remains on hold as hospitals’ lawsuit seeking to block it progresses. Judges called the district court’s decision to pause the pilot “careful and thorough” in their Jan. 7 order, while noting that the Trump administration had failed to convince them it would succeed on the merits of its case. <Read More> 

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Clinical Insights: December 23rd, 2025

New Drug/Vaccine Approval

Exdensur™ (depemokimab-ulaa) Injection - New Drug Approval – December 16, 2025 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Exdensur™ (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. <Read More>

Cardamyst™ (etripamil) Nasal Spray – New Drug Approval – December 12, 2025 – Milestone Pharmaceuticals Inc.  (Nasdaq: MIST) announced that the U.S. Food and Drug Administration (FDA) approved its first commercial product, Cardamyst™ (etripamil) nasal spray, a prescription medication for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. This approval marks the first time that more than two million Americans with PSVT will have a rapid-acting treatment option they can self-administer outside the emergency department or other healthcare setting. Cardamyst™ is expected to be available in retail pharmacies in the first quarter of 2026. <Read More> 

Nuzolvence® (zoliflodacin) Granules for Oral Suspension - New Drug Approval – December 12, 2025 – Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), announced that the U.S. Food and Drug Administration (FDA) has approved Nuzolvence® (zoliflodacin) for oral suspension, a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years and older weighing at least 35 kg. <Read More> 

Waskyra™ (etuvetidigene autotemcel) Suspension for Intravenous Infusion - New Drug Approval – December 9, 2025 - The U.S. Food and Drug Administration approved Waskyra™ (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS). Waskyra™ is indicated for pediatric patients six months and older and adults with WAS who have a mutation in the WAS gene and for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available. <Read More> 

Avance™ (acellular nerve allograft-arwx) for Surgical Implantation - New Drug Approval – December 3, 2025 – The U.S. Food and Drug Administration granted approval for Avance™ (acellular nerve allograft-arwx) in surgical implantation. Avance™ is a peripheral nerve scaffold approved for sensory nerve discontinuities (≤25mm) (breaks in the pathway of sensory nerves) in adults and pediatric patients aged one month and older. Under the Accelerated Approval pathway, Avance™ is also approved for larger sensory nerve discontinuities (>25mm), motor and mixed nerve discontinuities. <Read More> 

Voyxact® (sibeprenlimab-szsi) Injection - New Drug Approval – November 25, 2025 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Voyxact® (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. <Read More> 

Itvisma® (onasemnogene abeparvovec-brve) Suspension for Intrathecal Injection - New Drug Approval – November 24, 2025 – Novartis announced that the US Food and Drug Administration (FDA) has approved Itvisma® (onasemnogene abeparvovec-brve) for the treatment of children two years and older, teens and adults living with spinal muscular atrophy (SMA) with a confirmed mutation in the survival motor neuron 1 (SMN1) gene, making it the first and only gene replacement therapy available for this broad population. Itvisma® is uniquely designed to address the genetic root cause of SMA with a one-time fixed dose that does not need to be adjusted for age or body weight. By replacing the SMN1 gene, Itvisma® can improve motor function, offering the potential to reduce the need for chronically administered treatment associated with other available therapies for this population. <Read More> 

Hyrnuo® (sevabertinib) Tablets - New Drug Approval – November 18, 2025 – The Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo®, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. <Read More> 

Redemplo® (plozasiran) Injection - New Drug Approval – November 18, 2025 – Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) announced that the U.S. Food and Drug Administration (FDA) has approved Redemplo® (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). FCS is a severe, rare disease, with an estimated 6,500 people in the U.S. living with genetic or clinical FCS, characterized by triglyceride levels that can be 10 to 100 times higher than normal leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis. <Read More> 

New Label Expansions

Enhertu® (fam-trastuzumab deruxtecan-nxki) Injection – New Label Expansion – December 15, 2025 - AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the US for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, as determined by a Food and Drug Administration (FDA)-approved test. <Read More> 

Addyi® (flibanserin) Tablets – New Label Expansion – December 13, 2025 - Sprout Pharmaceuticals announced a monumental milestone for women's health: the U.S. Food and Drug Administration (FDA) has approved Addyi® (flibanserin 100 mg) for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in women <65 years. This long-awaited decision closes a gap in care for millions of postmenopausal women experiencing frustrating low sexual desire and marks a historic first approval for the FDA. <Read More> 

Akeega® (abiraterone acetate and niraparib) Tablets – New Label Expansion – December 12, 2025 – Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Akeega® (niraparib and abiraterone acetate dual-action tablet) plus prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). <Read More> 

Orladeyo® (berotralstat) Capsules and Oral Pellets - New Label Expansion – December 2, 2025 – BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for the use of an oral pellet formulation of once-daily Orladeyo® (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12 years. <Read More> 

Uplizna® (inebilizumab-cdon) Injection - New Label Expansion – December 11, 2025 – Amgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved Uplizna® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. The approval offers patients a new targeted treatment option that has the potential for long-term disease control with just two doses a year, after two initial loading doses. <Read More> 

Daybue® (trofinetide) Oral Solution and Powder for Oral Solution - New Label Expansion – December 11, 2025 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced that the U.S. Food and Drug Administration (FDA) has approved Daybue® Stix (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. <Read More> 

Blujepa® (gepotidacin) Tablets - New Label Expansion – December 11, 2025 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for gepotidacin as an oral option for adult and pediatric patients from 12 years of age weighing at least 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhea caused by susceptible strains of Neisseria gonorrhoeae (e.g., where standard of care is contraindicated, or where patients are intolerant or unwilling to use first line treatment). <Read More> 

Omisirge® (omidubicel-onlv) Suspension for Infusion - New Label Expansion – December 5, 2025 – The U.S. Food and Drug Administration announced it has approved Omisirge® (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). Omisirge® is indicated for adults and pediatric patients 12 years and older with hematologic malignancies and now is approved for adults and pediatric patients six years and older with SAA following reduced intensity conditioning and for whom a compatible donor is not available.  <Read More> 

Breyanzi® (lisocabtagene maraleucel) Suspension for Intravenous Infusion - New Label Expansion – December 4, 2025 – Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has granted 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 (R/R) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. <Read More> 

Jaypirca® (pirtobrutinib) Tablets - New Label Expansion – December 2, 2025 – The Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca®, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. <Read More> 

Omlyclo® (omalizumab-igec) Injection - New Label Expansion – December 1, 2025 – Celltrion, Inc. announced the U.S. Food and Drug Administration (FDA) has approved a new presentation of Omlyclo® (omalizumab-igec), the first and only biosimilar designated as interchangeable with Xolair® (omalizumab), in a 300mg/2mL solution in a single-dose prefilled syringe for subcutaneous injection. In the U.S., Omlyclo® will be marketed and distributed exclusively by Celltrion USA, Inc. <Read More> 

Imfinzi® (durvalumab) Injection - New Label Expansion – November 25, 2025 – AstraZeneca’s Imfinzi® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been approved in the US for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The approved regimen includes neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi® monotherapy. <Read More> 

Keytruda® (pembrolizumab) for Injection - New Label Expansion – November 21, 2025 – The Food and Drug Administration approved pembrolizumab (Keytruda®, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex®, Merck) with enfortumab vedotin-ejfv (Padcev®, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin. <Read More> 

Koselugo® (selumetinib) Capsules and Oral Granules - New Label Expansion – November 19, 2025 – The Food and Drug Administration approved selumetinib (Koselugo®, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication. <Read More> 

Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection - New Label Expansion – November 19, 2025 – The Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro®, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021. <Read More> 

Eylea HD® (aflibercept) Injection - New Label Expansion – November 19, 2025 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved Eylea HD® (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period. <Read More> 

Imdelltra™ (tarlatamab-dlle) for Injection - New Label Expansion – November 19, 2025 – The Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra™, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024. <Read More> 

Epkinly™ (epcoritamab-bysp) Injection - New Label Expansion – November 18, 2025 – The Food and Drug Administration approved epcoritamab-bysp (Epkinly™, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024). <Read More> 

New Drug Shortage

December 10, 2025

December 08, 2025

December 04, 2025

December 03, 2025

December 02, 2025

Updated Drug Shortage

December 17, 2025

December 16, 2025

December 15, 2025

December 12, 2025

December 11, 2025

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Armlupeg™ (pegfilgrastim-unne) Injection - New Neulasta® Biosimilar Approval – November 28, 2025 – Global pharma major Lupin Limited (Lupin), announced that the United States Food and Drug Administration (U.S. FDA) has approved Armlupeg™ (pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe, as biosimilar to Neulasta® (pegfilgrastim) 6 mg/0.6 mL injection. The product will be manufactured at Lupin’s Biotech facility in Pune, which was inspected by the U.S. FDA prior to approval. <Read More> 

Clinical and Pharmacy News

More Than 6,000 Medical Errors Every Year – December 18, 2025 - More than 20,000 cases of adverse medical events have been reported in our country over the past eight years, while more than 1,000 cases have reached the courts and received final rulings. The majority of these rulings vindicate those who filed claims after a medical error caused significant physical or psychological harm to themselves or their loved ones — and in some cases, the error even led to death. <Read More> 

Combination Pills for High Blood Pressure May Simplify Treatment, Improve Long-Term Health – December 15, 2025 – Taking one pill that combines two or more blood pressure medications may help adults with high blood pressure (also known as hypertension) lower their blood pressure level faster and more effectively than taking multiple medications separately, and it may also reduce the risk of heart attack and stroke, according to a new scientific statement published in the American Heart Association’s journal Hypertension. <Read More> 

Caring for Patients with Monkeypox – December 12, 2025 – Regardless of clade, monkeypox can be spread, treated, and prevented the same way. Most monkeypox patients without severe immunocompromise will recover with supportive care and pain control only. CDC's interim clinical guidance may assist clinicians in managing patients who have or are at risk for severe manifestations of monkeypox. There are no FDA-approved treatments specifically for monkeypox, but there are FDA-regulated medications that may help. <Read More> 

New Guidelines Recommend Nerve Blocks for Migraine ER Treatment – December 11, 2025 – People hospitalized for a debilitating migraine should receive targeted nerve blocks rather than IV opioids to quell their pain, a major update of treatment guidelines suggests. Doctors should use a nerve block injection to stop pain signals from thrumming through the occipital nerves located near the top of the spine, a report published in Headache: The Journal of Head and Face Pain, said. <Read More> 

Pharmacy and PBM Enforcement Trends: False Claims Act Risks in 2025 – December 11, 2025 – Pharmacy benefit managers (PBMs) manage prescription coverage for health plans and big employers. They decide which medicines are covered and at what price, negotiate discounts with drug makers, and set prices for pharmacies…Taken together, these matters demonstrate a renewed focus on pharmacy-related fraud. And while the financial recoveries differ dramatically, from hundreds of millions against national chains to a six-figure settlement against a small, independent pharmacy, the message is the same: Pharmacies and PBMs sit squarely in the DOJ’s enforcement sights. <Read More> 

ISMP Announces New Medication Safety Best Practices – December 11, 2025 – Improving safety with IV push medications, optimizing use of scanning machine-readable codes on patient identification bands and products, and improving the culture of safety are three new Targeted Medication Safety Best Practices suggested by the Institute for Safe Medication Practices (ISMP) for 2026-2027. These add to the 22 Best Practices suggested for 2024-2025, said Christina Michalek, RPh, FASHP, the director of membership and patient safety organization at ISMP, during a presentation at the ASHP Midyear 2025 Clinical Meeting & Exhibition, in Las Vegas. ISMP also updated two existing Best Practices: to add patient weights in electronic prescriptions and discharge and after-visit summaries, and to enhance medication reconciliation policies at hospital admission during transitions of care and at discharge. <Read More> 

FDA Warns Consumers Not to Use Counterfeit Ozempic® (Semaglutide) Found in U.S. Drug Supply Chain – December 5, 2025 – FDA recently seized dozens of units of counterfeit Ozempic® (semaglutide) injection 1 mg that were distributed illegally outside of Novo Nordisk's authorized supply chain. The seized counterfeit products were in the legitimate U.S. drug supply chain. The counterfeit products are labeled with lot number - PAR1229 - which also is an authentic lot number. <Read More> 

340B in the News

A New Call for 340B Transparency, Reform – December 12, 2025 – In a hearing that was at once contentious and unusually bipartisan, members of the Senate Health, Education, Labor and Pensions (HELP) Committee called for stronger oversight of the federal 340B Drug Discount Program while emphasizing its continued importance to safety-net hospitals and clinics. Witnesses from the Government Accountability Office (GAO), the Congressional Budget Office (CBO), and academic medicine testified on Oct. 23 that the program, intended to help hospitals stretch scarce financial resources, has grown exponentially while oversight has not kept pace. Senators from both parties urged reform but warned against changes that could undermine access to care for rural and underserved populations. <Read More> 

340B Discounts at Risk in 2025 and Beyond – December 12, 2025 – The 340B Drug Pricing Program faces intensifying scrutiny and legal battles at both state and federal levels in 2025. Pharmacy benefit managers (PBMs) are tightening point-of-sale claim identification, states are enacting anti-discrimination protections, and covered entities are waiting for the next shoe to drop. “Depending on who you’re speaking with, 340B is either the greatest thing since sliced bread—or Lord Voldemort himself,” said Jesse Dresser, Esq, a partner in Frier Levitt’s Life Sciences Department who heads the firm’s pharmacy practice group. <Read More> 

Read More

Clinical Insights: December 23rd, 2025

New Drug/Vaccine Approval

Exdensur™ (depemokimab-ulaa) Injection - New Drug Approval – December 16, 2025 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Exdensur™ (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. <Read More>

Cardamyst™ (etripamil) Nasal Spray – New Drug Approval – December 12, 2025 – Milestone Pharmaceuticals Inc.  (Nasdaq: MIST) announced that the U.S. Food and Drug Administration (FDA) approved its first commercial product, Cardamyst™ (etripamil) nasal spray, a prescription medication for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. This approval marks the first time that more than two million Americans with PSVT will have a rapid-acting treatment option they can self-administer outside the emergency department or other healthcare setting. Cardamyst™ is expected to be available in retail pharmacies in the first quarter of 2026. <Read More> 

Nuzolvence® (zoliflodacin) Granules for Oral Suspension - New Drug Approval – December 12, 2025 – Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), announced that the U.S. Food and Drug Administration (FDA) has approved Nuzolvence® (zoliflodacin) for oral suspension, a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years and older weighing at least 35 kg. <Read More> 

Waskyra™ (etuvetidigene autotemcel) Suspension for Intravenous Infusion - New Drug Approval – December 9, 2025 - The U.S. Food and Drug Administration approved Waskyra™ (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS). Waskyra™ is indicated for pediatric patients six months and older and adults with WAS who have a mutation in the WAS gene and for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available. <Read More> 

Avance™ (acellular nerve allograft-arwx) for Surgical Implantation - New Drug Approval – December 3, 2025 – The U.S. Food and Drug Administration granted approval for Avance™ (acellular nerve allograft-arwx) in surgical implantation. Avance™ is a peripheral nerve scaffold approved for sensory nerve discontinuities (≤25mm) (breaks in the pathway of sensory nerves) in adults and pediatric patients aged one month and older. Under the Accelerated Approval pathway, Avance™ is also approved for larger sensory nerve discontinuities (>25mm), motor and mixed nerve discontinuities. <Read More> 

Voyxact® (sibeprenlimab-szsi) Injection - New Drug Approval – November 25, 2025 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Voyxact® (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. <Read More> 

Itvisma® (onasemnogene abeparvovec-brve) Suspension for Intrathecal Injection - New Drug Approval – November 24, 2025 – Novartis announced that the US Food and Drug Administration (FDA) has approved Itvisma® (onasemnogene abeparvovec-brve) for the treatment of children two years and older, teens and adults living with spinal muscular atrophy (SMA) with a confirmed mutation in the survival motor neuron 1 (SMN1) gene, making it the first and only gene replacement therapy available for this broad population. Itvisma® is uniquely designed to address the genetic root cause of SMA with a one-time fixed dose that does not need to be adjusted for age or body weight. By replacing the SMN1 gene, Itvisma® can improve motor function, offering the potential to reduce the need for chronically administered treatment associated with other available therapies for this population. <Read More> 

Hyrnuo® (sevabertinib) Tablets - New Drug Approval – November 18, 2025 – The Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo®, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. <Read More> 

Redemplo® (plozasiran) Injection - New Drug Approval – November 18, 2025 – Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) announced that the U.S. Food and Drug Administration (FDA) has approved Redemplo® (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). FCS is a severe, rare disease, with an estimated 6,500 people in the U.S. living with genetic or clinical FCS, characterized by triglyceride levels that can be 10 to 100 times higher than normal leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis. <Read More> 

New Label Expansions

Enhertu® (fam-trastuzumab deruxtecan-nxki) Injection – New Label Expansion – December 15, 2025 - AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the US for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, as determined by a Food and Drug Administration (FDA)-approved test. <Read More> 

Addyi® (flibanserin) Tablets – New Label Expansion – December 13, 2025 - Sprout Pharmaceuticals announced a monumental milestone for women's health: the U.S. Food and Drug Administration (FDA) has approved Addyi® (flibanserin 100 mg) for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in women <65 years. This long-awaited decision closes a gap in care for millions of postmenopausal women experiencing frustrating low sexual desire and marks a historic first approval for the FDA. <Read More> 

Akeega® (abiraterone acetate and niraparib) Tablets – New Label Expansion – December 12, 2025 – Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Akeega® (niraparib and abiraterone acetate dual-action tablet) plus prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). <Read More> 

Orladeyo® (berotralstat) Capsules and Oral Pellets - New Label Expansion – December 2, 2025 – BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for the use of an oral pellet formulation of once-daily Orladeyo® (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12 years. <Read More> 

Uplizna® (inebilizumab-cdon) Injection - New Label Expansion – December 11, 2025 – Amgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved Uplizna® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. The approval offers patients a new targeted treatment option that has the potential for long-term disease control with just two doses a year, after two initial loading doses. <Read More> 

Daybue® (trofinetide) Oral Solution and Powder for Oral Solution - New Label Expansion – December 11, 2025 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced that the U.S. Food and Drug Administration (FDA) has approved Daybue® Stix (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. <Read More> 

Blujepa® (gepotidacin) Tablets - New Label Expansion – December 11, 2025 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for gepotidacin as an oral option for adult and pediatric patients from 12 years of age weighing at least 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhea caused by susceptible strains of Neisseria gonorrhoeae (e.g., where standard of care is contraindicated, or where patients are intolerant or unwilling to use first line treatment). <Read More> 

Omisirge® (omidubicel-onlv) Suspension for Infusion - New Label Expansion – December 5, 2025 – The U.S. Food and Drug Administration announced it has approved Omisirge® (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). Omisirge® is indicated for adults and pediatric patients 12 years and older with hematologic malignancies and now is approved for adults and pediatric patients six years and older with SAA following reduced intensity conditioning and for whom a compatible donor is not available.  <Read More> 

Breyanzi® (lisocabtagene maraleucel) Suspension for Intravenous Infusion - New Label Expansion – December 4, 2025 – Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has granted 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 (R/R) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. <Read More> 

Jaypirca® (pirtobrutinib) Tablets - New Label Expansion – December 2, 2025 – The Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca®, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. <Read More> 

Omlyclo® (omalizumab-igec) Injection - New Label Expansion – December 1, 2025 – Celltrion, Inc. announced the U.S. Food and Drug Administration (FDA) has approved a new presentation of Omlyclo® (omalizumab-igec), the first and only biosimilar designated as interchangeable with Xolair® (omalizumab), in a 300mg/2mL solution in a single-dose prefilled syringe for subcutaneous injection. In the U.S., Omlyclo® will be marketed and distributed exclusively by Celltrion USA, Inc. <Read More> 

Imfinzi® (durvalumab) Injection - New Label Expansion – November 25, 2025 – AstraZeneca’s Imfinzi® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been approved in the US for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The approved regimen includes neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi® monotherapy. <Read More> 

Keytruda® (pembrolizumab) for Injection - New Label Expansion – November 21, 2025 – The Food and Drug Administration approved pembrolizumab (Keytruda®, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex®, Merck) with enfortumab vedotin-ejfv (Padcev®, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin. <Read More> 

Koselugo® (selumetinib) Capsules and Oral Granules - New Label Expansion – November 19, 2025 – The Food and Drug Administration approved selumetinib (Koselugo®, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication. <Read More> 

Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection - New Label Expansion – November 19, 2025 – The Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro®, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021. <Read More> 

Eylea HD® (aflibercept) Injection - New Label Expansion – November 19, 2025 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved Eylea HD® (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period. <Read More> 

Imdelltra™ (tarlatamab-dlle) for Injection - New Label Expansion – November 19, 2025 – The Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra™, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024. <Read More> 

Epkinly™ (epcoritamab-bysp) Injection - New Label Expansion – November 18, 2025 – The Food and Drug Administration approved epcoritamab-bysp (Epkinly™, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024). <Read More> 

New Drug Shortage

December 10, 2025

December 08, 2025

December 04, 2025

December 03, 2025

December 02, 2025

Updated Drug Shortage

December 17, 2025

December 16, 2025

December 15, 2025

December 12, 2025

December 11, 2025

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Armlupeg™ (pegfilgrastim-unne) Injection - New Neulasta® Biosimilar Approval – November 28, 2025 – Global pharma major Lupin Limited (Lupin), announced that the United States Food and Drug Administration (U.S. FDA) has approved Armlupeg™ (pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe, as biosimilar to Neulasta® (pegfilgrastim) 6 mg/0.6 mL injection. The product will be manufactured at Lupin’s Biotech facility in Pune, which was inspected by the U.S. FDA prior to approval. <Read More> 

Clinical and Pharmacy News

More Than 6,000 Medical Errors Every Year – December 18, 2025 - More than 20,000 cases of adverse medical events have been reported in our country over the past eight years, while more than 1,000 cases have reached the courts and received final rulings. The majority of these rulings vindicate those who filed claims after a medical error caused significant physical or psychological harm to themselves or their loved ones — and in some cases, the error even led to death. <Read More> 

Combination Pills for High Blood Pressure May Simplify Treatment, Improve Long-Term Health – December 15, 2025 – Taking one pill that combines two or more blood pressure medications may help adults with high blood pressure (also known as hypertension) lower their blood pressure level faster and more effectively than taking multiple medications separately, and it may also reduce the risk of heart attack and stroke, according to a new scientific statement published in the American Heart Association’s journal Hypertension. <Read More> 

Caring for Patients with Monkeypox – December 12, 2025 – Regardless of clade, monkeypox can be spread, treated, and prevented the same way. Most monkeypox patients without severe immunocompromise will recover with supportive care and pain control only. CDC's interim clinical guidance may assist clinicians in managing patients who have or are at risk for severe manifestations of monkeypox. There are no FDA-approved treatments specifically for monkeypox, but there are FDA-regulated medications that may help. <Read More> 

New Guidelines Recommend Nerve Blocks for Migraine ER Treatment – December 11, 2025 – People hospitalized for a debilitating migraine should receive targeted nerve blocks rather than IV opioids to quell their pain, a major update of treatment guidelines suggests. Doctors should use a nerve block injection to stop pain signals from thrumming through the occipital nerves located near the top of the spine, a report published in Headache: The Journal of Head and Face Pain, said. <Read More> 

Pharmacy and PBM Enforcement Trends: False Claims Act Risks in 2025 – December 11, 2025 – Pharmacy benefit managers (PBMs) manage prescription coverage for health plans and big employers. They decide which medicines are covered and at what price, negotiate discounts with drug makers, and set prices for pharmacies…Taken together, these matters demonstrate a renewed focus on pharmacy-related fraud. And while the financial recoveries differ dramatically, from hundreds of millions against national chains to a six-figure settlement against a small, independent pharmacy, the message is the same: Pharmacies and PBMs sit squarely in the DOJ’s enforcement sights. <Read More> 

ISMP Announces New Medication Safety Best Practices – December 11, 2025 – Improving safety with IV push medications, optimizing use of scanning machine-readable codes on patient identification bands and products, and improving the culture of safety are three new Targeted Medication Safety Best Practices suggested by the Institute for Safe Medication Practices (ISMP) for 2026-2027. These add to the 22 Best Practices suggested for 2024-2025, said Christina Michalek, RPh, FASHP, the director of membership and patient safety organization at ISMP, during a presentation at the ASHP Midyear 2025 Clinical Meeting & Exhibition, in Las Vegas. ISMP also updated two existing Best Practices: to add patient weights in electronic prescriptions and discharge and after-visit summaries, and to enhance medication reconciliation policies at hospital admission during transitions of care and at discharge. <Read More> 

FDA Warns Consumers Not to Use Counterfeit Ozempic® (Semaglutide) Found in U.S. Drug Supply Chain – December 5, 2025 – FDA recently seized dozens of units of counterfeit Ozempic® (semaglutide) injection 1 mg that were distributed illegally outside of Novo Nordisk's authorized supply chain. The seized counterfeit products were in the legitimate U.S. drug supply chain. The counterfeit products are labeled with lot number - PAR1229 - which also is an authentic lot number. <Read More> 

340B in the News

A New Call for 340B Transparency, Reform – December 12, 2025 – In a hearing that was at once contentious and unusually bipartisan, members of the Senate Health, Education, Labor and Pensions (HELP) Committee called for stronger oversight of the federal 340B Drug Discount Program while emphasizing its continued importance to safety-net hospitals and clinics. Witnesses from the Government Accountability Office (GAO), the Congressional Budget Office (CBO), and academic medicine testified on Oct. 23 that the program, intended to help hospitals stretch scarce financial resources, has grown exponentially while oversight has not kept pace. Senators from both parties urged reform but warned against changes that could undermine access to care for rural and underserved populations. <Read More> 

340B Discounts at Risk in 2025 and Beyond – December 12, 2025 – The 340B Drug Pricing Program faces intensifying scrutiny and legal battles at both state and federal levels in 2025. Pharmacy benefit managers (PBMs) are tightening point-of-sale claim identification, states are enacting anti-discrimination protections, and covered entities are waiting for the next shoe to drop. “Depending on who you’re speaking with, 340B is either the greatest thing since sliced bread—or Lord Voldemort himself,” said Jesse Dresser, Esq, a partner in Frier Levitt’s Life Sciences Department who heads the firm’s pharmacy practice group. <Read More> 

Read More

Clinical Insights: December 23rd, 2025

New Drug/Vaccine Approval

Exdensur™ (depemokimab-ulaa) Injection - New Drug Approval – December 16, 2025 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Exdensur™ (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. <Read More>

Cardamyst™ (etripamil) Nasal Spray – New Drug Approval – December 12, 2025 – Milestone Pharmaceuticals Inc.  (Nasdaq: MIST) announced that the U.S. Food and Drug Administration (FDA) approved its first commercial product, Cardamyst™ (etripamil) nasal spray, a prescription medication for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. This approval marks the first time that more than two million Americans with PSVT will have a rapid-acting treatment option they can self-administer outside the emergency department or other healthcare setting. Cardamyst™ is expected to be available in retail pharmacies in the first quarter of 2026. <Read More> 

Nuzolvence® (zoliflodacin) Granules for Oral Suspension - New Drug Approval – December 12, 2025 – Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), announced that the U.S. Food and Drug Administration (FDA) has approved Nuzolvence® (zoliflodacin) for oral suspension, a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years and older weighing at least 35 kg. <Read More> 

Waskyra™ (etuvetidigene autotemcel) Suspension for Intravenous Infusion - New Drug Approval – December 9, 2025 - The U.S. Food and Drug Administration approved Waskyra™ (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS). Waskyra™ is indicated for pediatric patients six months and older and adults with WAS who have a mutation in the WAS gene and for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available. <Read More> 

Avance™ (acellular nerve allograft-arwx) for Surgical Implantation - New Drug Approval – December 3, 2025 – The U.S. Food and Drug Administration granted approval for Avance™ (acellular nerve allograft-arwx) in surgical implantation. Avance™ is a peripheral nerve scaffold approved for sensory nerve discontinuities (≤25mm) (breaks in the pathway of sensory nerves) in adults and pediatric patients aged one month and older. Under the Accelerated Approval pathway, Avance™ is also approved for larger sensory nerve discontinuities (>25mm), motor and mixed nerve discontinuities. <Read More> 

Voyxact® (sibeprenlimab-szsi) Injection - New Drug Approval – November 25, 2025 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Voyxact® (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. <Read More> 

Itvisma® (onasemnogene abeparvovec-brve) Suspension for Intrathecal Injection - New Drug Approval – November 24, 2025 – Novartis announced that the US Food and Drug Administration (FDA) has approved Itvisma® (onasemnogene abeparvovec-brve) for the treatment of children two years and older, teens and adults living with spinal muscular atrophy (SMA) with a confirmed mutation in the survival motor neuron 1 (SMN1) gene, making it the first and only gene replacement therapy available for this broad population. Itvisma® is uniquely designed to address the genetic root cause of SMA with a one-time fixed dose that does not need to be adjusted for age or body weight. By replacing the SMN1 gene, Itvisma® can improve motor function, offering the potential to reduce the need for chronically administered treatment associated with other available therapies for this population. <Read More> 

Hyrnuo® (sevabertinib) Tablets - New Drug Approval – November 18, 2025 – The Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo®, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. <Read More> 

Redemplo® (plozasiran) Injection - New Drug Approval – November 18, 2025 – Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) announced that the U.S. Food and Drug Administration (FDA) has approved Redemplo® (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). FCS is a severe, rare disease, with an estimated 6,500 people in the U.S. living with genetic or clinical FCS, characterized by triglyceride levels that can be 10 to 100 times higher than normal leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis. <Read More> 

New Label Expansions

Enhertu® (fam-trastuzumab deruxtecan-nxki) Injection – New Label Expansion – December 15, 2025 - AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the US for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, as determined by a Food and Drug Administration (FDA)-approved test. <Read More> 

Addyi® (flibanserin) Tablets – New Label Expansion – December 13, 2025 - Sprout Pharmaceuticals announced a monumental milestone for women's health: the U.S. Food and Drug Administration (FDA) has approved Addyi® (flibanserin 100 mg) for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in women <65 years. This long-awaited decision closes a gap in care for millions of postmenopausal women experiencing frustrating low sexual desire and marks a historic first approval for the FDA. <Read More> 

Akeega® (abiraterone acetate and niraparib) Tablets – New Label Expansion – December 12, 2025 – Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Akeega® (niraparib and abiraterone acetate dual-action tablet) plus prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). <Read More> 

Orladeyo® (berotralstat) Capsules and Oral Pellets - New Label Expansion – December 2, 2025 – BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for the use of an oral pellet formulation of once-daily Orladeyo® (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12 years. <Read More> 

Uplizna® (inebilizumab-cdon) Injection - New Label Expansion – December 11, 2025 – Amgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved Uplizna® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. The approval offers patients a new targeted treatment option that has the potential for long-term disease control with just two doses a year, after two initial loading doses. <Read More> 

Daybue® (trofinetide) Oral Solution and Powder for Oral Solution - New Label Expansion – December 11, 2025 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced that the U.S. Food and Drug Administration (FDA) has approved Daybue® Stix (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. <Read More> 

Blujepa® (gepotidacin) Tablets - New Label Expansion – December 11, 2025 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for gepotidacin as an oral option for adult and pediatric patients from 12 years of age weighing at least 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhea caused by susceptible strains of Neisseria gonorrhoeae (e.g., where standard of care is contraindicated, or where patients are intolerant or unwilling to use first line treatment). <Read More> 

Omisirge® (omidubicel-onlv) Suspension for Infusion - New Label Expansion – December 5, 2025 – The U.S. Food and Drug Administration announced it has approved Omisirge® (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). Omisirge® is indicated for adults and pediatric patients 12 years and older with hematologic malignancies and now is approved for adults and pediatric patients six years and older with SAA following reduced intensity conditioning and for whom a compatible donor is not available.  <Read More> 

Breyanzi® (lisocabtagene maraleucel) Suspension for Intravenous Infusion - New Label Expansion – December 4, 2025 – Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has granted 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 (R/R) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. <Read More> 

Jaypirca® (pirtobrutinib) Tablets - New Label Expansion – December 2, 2025 – The Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca®, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. <Read More> 

Omlyclo® (omalizumab-igec) Injection - New Label Expansion – December 1, 2025 – Celltrion, Inc. announced the U.S. Food and Drug Administration (FDA) has approved a new presentation of Omlyclo® (omalizumab-igec), the first and only biosimilar designated as interchangeable with Xolair® (omalizumab), in a 300mg/2mL solution in a single-dose prefilled syringe for subcutaneous injection. In the U.S., Omlyclo® will be marketed and distributed exclusively by Celltrion USA, Inc. <Read More> 

Imfinzi® (durvalumab) Injection - New Label Expansion – November 25, 2025 – AstraZeneca’s Imfinzi® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been approved in the US for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The approved regimen includes neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi® monotherapy. <Read More> 

Keytruda® (pembrolizumab) for Injection - New Label Expansion – November 21, 2025 – The Food and Drug Administration approved pembrolizumab (Keytruda®, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex®, Merck) with enfortumab vedotin-ejfv (Padcev®, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin. <Read More> 

Koselugo® (selumetinib) Capsules and Oral Granules - New Label Expansion – November 19, 2025 – The Food and Drug Administration approved selumetinib (Koselugo®, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication. <Read More> 

Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection - New Label Expansion – November 19, 2025 – The Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro®, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021. <Read More> 

Eylea HD® (aflibercept) Injection - New Label Expansion – November 19, 2025 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved Eylea HD® (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period. <Read More> 

Imdelltra™ (tarlatamab-dlle) for Injection - New Label Expansion – November 19, 2025 – The Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra™, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024. <Read More> 

Epkinly™ (epcoritamab-bysp) Injection - New Label Expansion – November 18, 2025 – The Food and Drug Administration approved epcoritamab-bysp (Epkinly™, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024). <Read More> 

New Drug Shortage

December 10, 2025

December 08, 2025

December 04, 2025

December 03, 2025

December 02, 2025

Updated Drug Shortage

December 17, 2025

December 16, 2025

December 15, 2025

December 12, 2025

December 11, 2025

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Armlupeg™ (pegfilgrastim-unne) Injection - New Neulasta® Biosimilar Approval – November 28, 2025 – Global pharma major Lupin Limited (Lupin), announced that the United States Food and Drug Administration (U.S. FDA) has approved Armlupeg™ (pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe, as biosimilar to Neulasta® (pegfilgrastim) 6 mg/0.6 mL injection. The product will be manufactured at Lupin’s Biotech facility in Pune, which was inspected by the U.S. FDA prior to approval. <Read More> 

Clinical and Pharmacy News

More Than 6,000 Medical Errors Every Year – December 18, 2025 - More than 20,000 cases of adverse medical events have been reported in our country over the past eight years, while more than 1,000 cases have reached the courts and received final rulings. The majority of these rulings vindicate those who filed claims after a medical error caused significant physical or psychological harm to themselves or their loved ones — and in some cases, the error even led to death. <Read More> 

Combination Pills for High Blood Pressure May Simplify Treatment, Improve Long-Term Health – December 15, 2025 – Taking one pill that combines two or more blood pressure medications may help adults with high blood pressure (also known as hypertension) lower their blood pressure level faster and more effectively than taking multiple medications separately, and it may also reduce the risk of heart attack and stroke, according to a new scientific statement published in the American Heart Association’s journal Hypertension. <Read More> 

Caring for Patients with Monkeypox – December 12, 2025 – Regardless of clade, monkeypox can be spread, treated, and prevented the same way. Most monkeypox patients without severe immunocompromise will recover with supportive care and pain control only. CDC's interim clinical guidance may assist clinicians in managing patients who have or are at risk for severe manifestations of monkeypox. There are no FDA-approved treatments specifically for monkeypox, but there are FDA-regulated medications that may help. <Read More> 

New Guidelines Recommend Nerve Blocks for Migraine ER Treatment – December 11, 2025 – People hospitalized for a debilitating migraine should receive targeted nerve blocks rather than IV opioids to quell their pain, a major update of treatment guidelines suggests. Doctors should use a nerve block injection to stop pain signals from thrumming through the occipital nerves located near the top of the spine, a report published in Headache: The Journal of Head and Face Pain, said. <Read More> 

Pharmacy and PBM Enforcement Trends: False Claims Act Risks in 2025 – December 11, 2025 – Pharmacy benefit managers (PBMs) manage prescription coverage for health plans and big employers. They decide which medicines are covered and at what price, negotiate discounts with drug makers, and set prices for pharmacies…Taken together, these matters demonstrate a renewed focus on pharmacy-related fraud. And while the financial recoveries differ dramatically, from hundreds of millions against national chains to a six-figure settlement against a small, independent pharmacy, the message is the same: Pharmacies and PBMs sit squarely in the DOJ’s enforcement sights. <Read More> 

ISMP Announces New Medication Safety Best Practices – December 11, 2025 – Improving safety with IV push medications, optimizing use of scanning machine-readable codes on patient identification bands and products, and improving the culture of safety are three new Targeted Medication Safety Best Practices suggested by the Institute for Safe Medication Practices (ISMP) for 2026-2027. These add to the 22 Best Practices suggested for 2024-2025, said Christina Michalek, RPh, FASHP, the director of membership and patient safety organization at ISMP, during a presentation at the ASHP Midyear 2025 Clinical Meeting & Exhibition, in Las Vegas. ISMP also updated two existing Best Practices: to add patient weights in electronic prescriptions and discharge and after-visit summaries, and to enhance medication reconciliation policies at hospital admission during transitions of care and at discharge. <Read More> 

FDA Warns Consumers Not to Use Counterfeit Ozempic® (Semaglutide) Found in U.S. Drug Supply Chain – December 5, 2025 – FDA recently seized dozens of units of counterfeit Ozempic® (semaglutide) injection 1 mg that were distributed illegally outside of Novo Nordisk's authorized supply chain. The seized counterfeit products were in the legitimate U.S. drug supply chain. The counterfeit products are labeled with lot number - PAR1229 - which also is an authentic lot number. <Read More> 

340B in the News

A New Call for 340B Transparency, Reform – December 12, 2025 – In a hearing that was at once contentious and unusually bipartisan, members of the Senate Health, Education, Labor and Pensions (HELP) Committee called for stronger oversight of the federal 340B Drug Discount Program while emphasizing its continued importance to safety-net hospitals and clinics. Witnesses from the Government Accountability Office (GAO), the Congressional Budget Office (CBO), and academic medicine testified on Oct. 23 that the program, intended to help hospitals stretch scarce financial resources, has grown exponentially while oversight has not kept pace. Senators from both parties urged reform but warned against changes that could undermine access to care for rural and underserved populations. <Read More> 

340B Discounts at Risk in 2025 and Beyond – December 12, 2025 – The 340B Drug Pricing Program faces intensifying scrutiny and legal battles at both state and federal levels in 2025. Pharmacy benefit managers (PBMs) are tightening point-of-sale claim identification, states are enacting anti-discrimination protections, and covered entities are waiting for the next shoe to drop. “Depending on who you’re speaking with, 340B is either the greatest thing since sliced bread—or Lord Voldemort himself,” said Jesse Dresser, Esq, a partner in Frier Levitt’s Life Sciences Department who heads the firm’s pharmacy practice group. <Read More> 

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Clinical Insights: November 21st, 2025

New Drug/Vaccine Approval

Komzifti™ (ziftomenib) Capsules - New Drug Approval – November 13, 2025 – The Food and Drug Administration approved ziftomenib (Komzifti™, Kura Oncology, Inc.), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options. <Read More>

Kygevvi® (doxecitine and doxribtimine) Powder for Oral Solution - New Drug Approval –November 3, 2025 – The U.S. Food and Drug Administration (FDA) approved Kygevvi® (doxecitine and doxribtimine) powder to treat thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients who start to show symptoms when they are 12 years old or younger. Kygevvi® received Breakthrough Therapy Designation for this indication. <Read More> 

Lynkuet® (elinzanetant) Capsules - New Drug Approval – October 24, 2025 – Bayer announced the U.S. Food and Drug Administration (FDA) has approved Lynkuet® (elinzanetant) 60mg capsules, the first and only dual neurokinin (NK) targeted therapy, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, for the treatment of moderate to severe hot flashes due to menopause. <Read More>

Javadin™ (clonidine hydrochloride) Oral Solution - New Drug Approval – October 23, 2025 – Azurity Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Javadin™ (clonidine hydrochloride) oral solution, the only FDA-approved, immediate-release, ready-to-use oral liquid clonidine formulation for the treatment of hypertension in adult patients to lower blood pressure. <Read More> 

Epioxa™ (riboflavin 5’-phosphate) Ophthalmic Solution - New Drug Approval – October 17, 2025 - Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases, announced the U.S. Food and Drug Administration (FDA) approved its Epioxa™ HD / Epioxa™ (“Epioxa”) New Drug Application (NDA). Epioxa™ is a groundbreaking advancement in corneal cross-linking for the treatment of keratoconus, a rare, sight-threatening disease that is currently far too often undiagnosed and untreated. <Read More>

Ferabright™ (ferumoxytol) Injection - New Drug Approval – October 16, 2025 - Azurity Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Ferabright™ (ferumoxytol injection), the first and only iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier. <Read More> 

New Label Expansions

Elevidys® (delandistrogene moxeparvovec-rokl) Suspension for Intravenous Infusion – New Label Expansion – November 14, 2025 - Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, announced an update to the prescribing information for Elevidys® (delandistrogene moxeparvovec-rokl), the only approved gene therapy for Duchenne muscular dystrophy (DMD). <Read More>  

Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection – New Label Expansion – November 6, 2025 - Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). Darzalex Faspro® is the first and only approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma. <Read More> 

Caplyta® (lumateperone) Capsules – New Label Expansion – November 5, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) approved Caplyta® (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. <Read More> 

Linzess® (linaclotide) Capsules – New Label Expansion – November 4, 2025 - The U.S. Food and Drug Administration (FDA) has approved Linzess® (linaclotide) capsules for pediatric patients 7 years and older with irritable bowel syndrome with constipation (IBS-C). Linzess® is the first treatment approved for IBS-C in pediatric patients. <Read More> 

Stoboclo® (denosumab-bmwo) Injection – New Label Expansion – October 29, 2025 – Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated Stoboclo® (denosumab-bmwo) and Osenvelt® (denosumab-bmwo) as interchangeable biosimilars to the reference products Prolia® (denosumab) and Xgeva® (denosumab), respectively, for all approved indications. <Read More>

Conexxence® (denosumab-bnht) Injection – New Label Expansion – October 29, 2025 - Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced that the U.S. Food and Drug Administration (FDA) designated Conexxence® and Bomyntra® (denosumab-bnht) as interchangeable biosimilars to the reference products, Prolia® (denosumab) and Xgeva® (denosumab), respectively. <Read More> 

Winrevair™ (sotatercept) for Injection – New Label Expansion – October 24, 2025 - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. product label based on the Phase 3 ZENITH trial for Winrevair™ (sotatercept-csrk) for injection, 45mg, 60mg. Winrevair™, an activin signaling inhibitor, is now FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death. <Read More> 

Revuforj® (revumenib) Tablets – New Label Expansion – October 24, 2025 - Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj® (revumenib) for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. <Read More> 

Blenrep® (belantamab mafodotin-blmf) Injection – New Label Expansion – October 23, 2025 - GSK plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved Blenrep® (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent. <Read More> 

Omvoh® (mirikizumab-mrkz) Injection – New Label Expansion – October 23, 2025 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of Omvoh® (mirikizumab-mrkz) for subcutaneous use in adults with moderately to severely active ulcerative colitis (UC). <Read More> 

Gazyva® (obinutuzumab) Injection – New Label Expansion – October 17, 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 Gazyva® (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients. <Read More> 

New Drug Shortage

November 17, 2025

November 14, 2025

November 13, 2025

November 12, 2025

November 7, 2025

Updated Drug Shortage

November 18, 2025

November 17, 2025

November 14, 2025

November 13, 2025

November 10, 2025

New Drug Recall and Safety Alerts

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial by Fresenius Kabi – New Voluntary Recall – November 7, 2025 - Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL vial. This recall is being performed to the user level in the United States. <Read More> 

Potassium Chloride 20 mEq Injection by Otsuka ICU Medical LLC – New Voluntary Recall – November 3, 2025 – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq with NDC 0990-7074-26. <Read More> 

New Generic/Biosimilar Approval and Launch

Poherdy™ (pertuzumab-dpzb) Injection - New Perjeta® Biosimilar Approval – November 13, 2025 – The Food and Drug Administration approved Poherdy™ (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta® (pertuzumab, Genentech Inc.). This is the first approval of a biosimilar for Perjeta®. <Read More> 

Clinical and Pharmacy News

Government Shutdown Now Over as Federal Agencies Reopen and Employees Return to Work – November 13, 2025 – With the shutdown finally in the rearview mirror, the focus in the Senate is turning to an upcoming fight over health care, with Democrats hoping to regroup after splintering in the final stages of the showdown. Eight Senate Democrats broke ranks to reach a deal with Republicans to end the shutdown, dashing the party's effort to win an extension of expiring Affordable Care Act tax credits in return for their vote to reopen the government. Now, Democrats face a quick timeline to shift their strategy. <Read More> 

ADHD Medication Recalled Nationwide Because Users Aren’t Getting the Full Effect – November 11, 2025 – A popular ADHD medication is being recalled nationwide because its users won’t be able to get the full effect. According to the Food and Drug Administration, several lots of lisdexamfetamine dimesylate capsules, a generic form of Vyvanse®, are being recalled. The recall was announced Oct. 28. The Board of Pharmacy said the medication failed dissolution tests, writing, “Dissolution is important for drugs to be absorbed and have a physiological effect on the human body; they must be in solution. The impacted capsules would not be able to deliver an optimal level of medicine and may impact the therapeutic efficacy of the product.” <Read More> 

CMS Announces GENEROUS Model to Lower Medicaid Drug Prices – November 6, 2025 – CMS announced the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model, a new drug payment model that will aim to lower prescription drug spending in Medicaid and strengthen the program overall. The GENEROUS model, launching in 2026, will allow participating states to purchase drugs included in the pilot at prices in line with those in other nations, with a goal of increasing access to medications and improving health outcomes among Medicaid beneficiaries. The announcement adds to a recent flurry of Trump administration initiatives aimed at addressing high drug prices in the US, including the Most Favored Nation (MFN) executive order and subsequent drug pricing deals with Pfizer, AstraZeneca, Novo Nordisk, and Eli Lilly and Company. <Read More> 

Certain Obesity Drugs Will Cost as Little as $149 And Medicare Will Start Covering Them Under White House Deals – November 6, 2025 – Certain blockbuster obesity drugs will be available for as little as $149 per month and more Medicare enrollees will have access to them under two deals announced Thursday by the Trump administration.The arrangements with drugmakers Eli Lilly and Novo Nordisk, which President Donald Trump foreshadowed in remarks last month, are the latest in the administration’s efforts to lower drug prices. As part of the new deals, the drugmakers have also agreed to match prices to the lowest paid in peer nations for all their drugs in Medicaid as well as for the list prices when their medications first hit the market. They will also offer primary care medicines directly to consumers at discounted prices. <Read More> 

New Data Shows Local Pharmacy Shortages – November 5, 2025 – A new mapping tool from the National Community Pharmacists Association and University of Southern California shows a few  pharmacy shortage areas in the Tri-Cities. At least three suburban and five rural neighborhoods are considered lacking across Carter, Hawkins, Johnson, Sullivan, Unicoi and Washington counties. Southwest Virginia also has three shortage areas between Bristol and Abingdon. These regions are defined by how far people need to travel to reach the nearest pharmacy: more than 10 miles in rural areas, two miles in suburbs and one mile in urban neighborhoods. Community pharmacies are critical access points in their communities, said Dr. Ronna Hauser, senior vice president of policy and pharmacy affairs for the NCPA. <Read More> 

Evaluating Pediatric Medication Errors: A Feasibility Study – November 5, 2025 - In a groundbreaking study published in BMC Pediatrics, researchers have delved into a critical yet often overlooked aspect of pediatric healthcare: medication discrepancies. The research conducted by an experienced team, including Mercümek, Bektay, and Uzuner, among others, sheds light on the alarming inconsistencies that can occur in the medication administered to young patients. The objective of this study was to evaluate the occurrence of medication discrepancies within a pediatric ward, utilizing a novel framework known as the Medication Discrepancy Taxonomy (MedTax). <Read More>  

AFPs Affect Access to Specialty Medications – October 30, 2025 - The use of alternative funding programs (AFPs) significantly reduces the likelihood of beneficiaries accessing needed medications, increases time to treatment, and is associated with more gaps in therapy and adverse clinical outcomes compared with traditional pharmacy benefits. Pharmacists at a dozen health systems presented these new results about AFPs—for-profit third-party vendors used by self-funded employer plans that carve out certain medications as “nonessential health benefits” and attempt to obtain medication from non-health plan sources—in a presentation at AMCP Nexus 2025, in National Harbor, Maryland (poster 138). <Read More> 

Many Unanswered Questions: Will the Trump Administration’s Drug Pricing Deals Result in Any Cost Savings for State Medicaid Programs? – October 29, 2025 - Over the last month, the White House has widely touted pricing agreements from two drug manufacturers — Pfizer and AstraZeneca — which it claims will result in substantial prescription drug cost savings for state Medicaid programs.  According to the White House, under these agreements, the manufacturers will provide “Most Favored Nation (MFN)” prices, based on lower international prices paid by other nations, to all state Medicaid programs.  This follows from a May 2025 executive order promoting MFN pricing. <Read More> 

EmblemHealth taps Prime Therapeutics, Amazon for new Pharmacy Benefit Collaboration – October 29, 2025 - New York-based insurer EmblemHealth is teaming up with Prime Therapeutics to rethink the pharmacy benefit experience for its members. Emblem will tap into Prime's tech stack, which allows real-time referrals for specialty drugs instead of the more traditional network structure. In this model, it encourages competitive pricing for specialty products when ensuring members feel the savings directly, the insurer said in an announcement. <Read More> 

340B in the News

Rage Over Rebates: Hospitals Oppose 340B Pilot Program – November 12, 2025 - The federal government is testing a new method of delivering discounts in a program aimed to help hospitals buy certain drugs at lower prices, and health systems aren’t happy about it. The government is testing a new pilot program that would move from hospitals simply buying the drugs at lower prices in the federal 340B Drug Discount Program. The Health Resources and Services Administration said late last month it’s testing a new program with eight companies that would offer rebates to hospitals after they have purchased the drugs. The agency said it is testing plans from large drug companies including Bristol Myers Squibb, Astra Zeneca, and Novo Nordisk Inc. The pilot program is slated to launch Jan. 1. <Read More> 

340B Rebate Models and Medicare Part D 340B Claims: What 340B Covered Entities Need to Know for 2026 – November 11, 2025 – 340B covered entities should carefully review the approved 340B rebate models and the 2026 Medicare Physician Fee Schedule (MPFS) Final Rule provisions on new CMS processes for identifying Medicare Part D claims for 340B drugs. While the current scope may seem limited or not applicable to certain 340B covered entities, now is the most important time to evaluate the implications of these programs if expanded to all 340B drugs and all 340B covered entities in order to ensure that the concerns of 340B covered entities are appropriately addressed. <Read More> 

Read More

Clinical Insights: November 21st, 2025

New Drug/Vaccine Approval

Komzifti™ (ziftomenib) Capsules - New Drug Approval – November 13, 2025 – The Food and Drug Administration approved ziftomenib (Komzifti™, Kura Oncology, Inc.), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options. <Read More>

Kygevvi® (doxecitine and doxribtimine) Powder for Oral Solution - New Drug Approval –November 3, 2025 – The U.S. Food and Drug Administration (FDA) approved Kygevvi® (doxecitine and doxribtimine) powder to treat thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients who start to show symptoms when they are 12 years old or younger. Kygevvi® received Breakthrough Therapy Designation for this indication. <Read More> 

Lynkuet® (elinzanetant) Capsules - New Drug Approval – October 24, 2025 – Bayer announced the U.S. Food and Drug Administration (FDA) has approved Lynkuet® (elinzanetant) 60mg capsules, the first and only dual neurokinin (NK) targeted therapy, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, for the treatment of moderate to severe hot flashes due to menopause. <Read More>

Javadin™ (clonidine hydrochloride) Oral Solution - New Drug Approval – October 23, 2025 – Azurity Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Javadin™ (clonidine hydrochloride) oral solution, the only FDA-approved, immediate-release, ready-to-use oral liquid clonidine formulation for the treatment of hypertension in adult patients to lower blood pressure. <Read More> 

Epioxa™ (riboflavin 5’-phosphate) Ophthalmic Solution - New Drug Approval – October 17, 2025 - Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases, announced the U.S. Food and Drug Administration (FDA) approved its Epioxa™ HD / Epioxa™ (“Epioxa”) New Drug Application (NDA). Epioxa™ is a groundbreaking advancement in corneal cross-linking for the treatment of keratoconus, a rare, sight-threatening disease that is currently far too often undiagnosed and untreated. <Read More>

Ferabright™ (ferumoxytol) Injection - New Drug Approval – October 16, 2025 - Azurity Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Ferabright™ (ferumoxytol injection), the first and only iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier. <Read More> 

New Label Expansions

Elevidys® (delandistrogene moxeparvovec-rokl) Suspension for Intravenous Infusion – New Label Expansion – November 14, 2025 - Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, announced an update to the prescribing information for Elevidys® (delandistrogene moxeparvovec-rokl), the only approved gene therapy for Duchenne muscular dystrophy (DMD). <Read More>  

Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection – New Label Expansion – November 6, 2025 - Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). Darzalex Faspro® is the first and only approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma. <Read More> 

Caplyta® (lumateperone) Capsules – New Label Expansion – November 5, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) approved Caplyta® (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. <Read More> 

Linzess® (linaclotide) Capsules – New Label Expansion – November 4, 2025 - The U.S. Food and Drug Administration (FDA) has approved Linzess® (linaclotide) capsules for pediatric patients 7 years and older with irritable bowel syndrome with constipation (IBS-C). Linzess® is the first treatment approved for IBS-C in pediatric patients. <Read More> 

Stoboclo® (denosumab-bmwo) Injection – New Label Expansion – October 29, 2025 – Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated Stoboclo® (denosumab-bmwo) and Osenvelt® (denosumab-bmwo) as interchangeable biosimilars to the reference products Prolia® (denosumab) and Xgeva® (denosumab), respectively, for all approved indications. <Read More>

Conexxence® (denosumab-bnht) Injection – New Label Expansion – October 29, 2025 - Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced that the U.S. Food and Drug Administration (FDA) designated Conexxence® and Bomyntra® (denosumab-bnht) as interchangeable biosimilars to the reference products, Prolia® (denosumab) and Xgeva® (denosumab), respectively. <Read More> 

Winrevair™ (sotatercept) for Injection – New Label Expansion – October 24, 2025 - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. product label based on the Phase 3 ZENITH trial for Winrevair™ (sotatercept-csrk) for injection, 45mg, 60mg. Winrevair™, an activin signaling inhibitor, is now FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death. <Read More> 

Revuforj® (revumenib) Tablets – New Label Expansion – October 24, 2025 - Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj® (revumenib) for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. <Read More> 

Blenrep® (belantamab mafodotin-blmf) Injection – New Label Expansion – October 23, 2025 - GSK plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved Blenrep® (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent. <Read More> 

Omvoh® (mirikizumab-mrkz) Injection – New Label Expansion – October 23, 2025 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of Omvoh® (mirikizumab-mrkz) for subcutaneous use in adults with moderately to severely active ulcerative colitis (UC). <Read More> 

Gazyva® (obinutuzumab) Injection – New Label Expansion – October 17, 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 Gazyva® (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients. <Read More> 

New Drug Shortage

November 17, 2025

November 14, 2025

November 13, 2025

November 12, 2025

November 7, 2025

Updated Drug Shortage

November 18, 2025

November 17, 2025

November 14, 2025

November 13, 2025

November 10, 2025

New Drug Recall and Safety Alerts

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial by Fresenius Kabi – New Voluntary Recall – November 7, 2025 - Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL vial. This recall is being performed to the user level in the United States. <Read More> 

Potassium Chloride 20 mEq Injection by Otsuka ICU Medical LLC – New Voluntary Recall – November 3, 2025 – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq with NDC 0990-7074-26. <Read More> 

New Generic/Biosimilar Approval and Launch

Poherdy™ (pertuzumab-dpzb) Injection - New Perjeta® Biosimilar Approval – November 13, 2025 – The Food and Drug Administration approved Poherdy™ (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta® (pertuzumab, Genentech Inc.). This is the first approval of a biosimilar for Perjeta®. <Read More> 

Clinical and Pharmacy News

Government Shutdown Now Over as Federal Agencies Reopen and Employees Return to Work – November 13, 2025 – With the shutdown finally in the rearview mirror, the focus in the Senate is turning to an upcoming fight over health care, with Democrats hoping to regroup after splintering in the final stages of the showdown. Eight Senate Democrats broke ranks to reach a deal with Republicans to end the shutdown, dashing the party's effort to win an extension of expiring Affordable Care Act tax credits in return for their vote to reopen the government. Now, Democrats face a quick timeline to shift their strategy. <Read More> 

ADHD Medication Recalled Nationwide Because Users Aren’t Getting the Full Effect – November 11, 2025 – A popular ADHD medication is being recalled nationwide because its users won’t be able to get the full effect. According to the Food and Drug Administration, several lots of lisdexamfetamine dimesylate capsules, a generic form of Vyvanse®, are being recalled. The recall was announced Oct. 28. The Board of Pharmacy said the medication failed dissolution tests, writing, “Dissolution is important for drugs to be absorbed and have a physiological effect on the human body; they must be in solution. The impacted capsules would not be able to deliver an optimal level of medicine and may impact the therapeutic efficacy of the product.” <Read More> 

CMS Announces GENEROUS Model to Lower Medicaid Drug Prices – November 6, 2025 – CMS announced the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model, a new drug payment model that will aim to lower prescription drug spending in Medicaid and strengthen the program overall. The GENEROUS model, launching in 2026, will allow participating states to purchase drugs included in the pilot at prices in line with those in other nations, with a goal of increasing access to medications and improving health outcomes among Medicaid beneficiaries. The announcement adds to a recent flurry of Trump administration initiatives aimed at addressing high drug prices in the US, including the Most Favored Nation (MFN) executive order and subsequent drug pricing deals with Pfizer, AstraZeneca, Novo Nordisk, and Eli Lilly and Company. <Read More> 

Certain Obesity Drugs Will Cost as Little as $149 And Medicare Will Start Covering Them Under White House Deals – November 6, 2025 – Certain blockbuster obesity drugs will be available for as little as $149 per month and more Medicare enrollees will have access to them under two deals announced Thursday by the Trump administration.The arrangements with drugmakers Eli Lilly and Novo Nordisk, which President Donald Trump foreshadowed in remarks last month, are the latest in the administration’s efforts to lower drug prices. As part of the new deals, the drugmakers have also agreed to match prices to the lowest paid in peer nations for all their drugs in Medicaid as well as for the list prices when their medications first hit the market. They will also offer primary care medicines directly to consumers at discounted prices. <Read More> 

New Data Shows Local Pharmacy Shortages – November 5, 2025 – A new mapping tool from the National Community Pharmacists Association and University of Southern California shows a few  pharmacy shortage areas in the Tri-Cities. At least three suburban and five rural neighborhoods are considered lacking across Carter, Hawkins, Johnson, Sullivan, Unicoi and Washington counties. Southwest Virginia also has three shortage areas between Bristol and Abingdon. These regions are defined by how far people need to travel to reach the nearest pharmacy: more than 10 miles in rural areas, two miles in suburbs and one mile in urban neighborhoods. Community pharmacies are critical access points in their communities, said Dr. Ronna Hauser, senior vice president of policy and pharmacy affairs for the NCPA. <Read More> 

Evaluating Pediatric Medication Errors: A Feasibility Study – November 5, 2025 - In a groundbreaking study published in BMC Pediatrics, researchers have delved into a critical yet often overlooked aspect of pediatric healthcare: medication discrepancies. The research conducted by an experienced team, including Mercümek, Bektay, and Uzuner, among others, sheds light on the alarming inconsistencies that can occur in the medication administered to young patients. The objective of this study was to evaluate the occurrence of medication discrepancies within a pediatric ward, utilizing a novel framework known as the Medication Discrepancy Taxonomy (MedTax). <Read More>  

AFPs Affect Access to Specialty Medications – October 30, 2025 - The use of alternative funding programs (AFPs) significantly reduces the likelihood of beneficiaries accessing needed medications, increases time to treatment, and is associated with more gaps in therapy and adverse clinical outcomes compared with traditional pharmacy benefits. Pharmacists at a dozen health systems presented these new results about AFPs—for-profit third-party vendors used by self-funded employer plans that carve out certain medications as “nonessential health benefits” and attempt to obtain medication from non-health plan sources—in a presentation at AMCP Nexus 2025, in National Harbor, Maryland (poster 138). <Read More> 

Many Unanswered Questions: Will the Trump Administration’s Drug Pricing Deals Result in Any Cost Savings for State Medicaid Programs? – October 29, 2025 - Over the last month, the White House has widely touted pricing agreements from two drug manufacturers — Pfizer and AstraZeneca — which it claims will result in substantial prescription drug cost savings for state Medicaid programs.  According to the White House, under these agreements, the manufacturers will provide “Most Favored Nation (MFN)” prices, based on lower international prices paid by other nations, to all state Medicaid programs.  This follows from a May 2025 executive order promoting MFN pricing. <Read More> 

EmblemHealth taps Prime Therapeutics, Amazon for new Pharmacy Benefit Collaboration – October 29, 2025 - New York-based insurer EmblemHealth is teaming up with Prime Therapeutics to rethink the pharmacy benefit experience for its members. Emblem will tap into Prime's tech stack, which allows real-time referrals for specialty drugs instead of the more traditional network structure. In this model, it encourages competitive pricing for specialty products when ensuring members feel the savings directly, the insurer said in an announcement. <Read More> 

340B in the News

Rage Over Rebates: Hospitals Oppose 340B Pilot Program – November 12, 2025 - The federal government is testing a new method of delivering discounts in a program aimed to help hospitals buy certain drugs at lower prices, and health systems aren’t happy about it. The government is testing a new pilot program that would move from hospitals simply buying the drugs at lower prices in the federal 340B Drug Discount Program. The Health Resources and Services Administration said late last month it’s testing a new program with eight companies that would offer rebates to hospitals after they have purchased the drugs. The agency said it is testing plans from large drug companies including Bristol Myers Squibb, Astra Zeneca, and Novo Nordisk Inc. The pilot program is slated to launch Jan. 1. <Read More> 

340B Rebate Models and Medicare Part D 340B Claims: What 340B Covered Entities Need to Know for 2026 – November 11, 2025 – 340B covered entities should carefully review the approved 340B rebate models and the 2026 Medicare Physician Fee Schedule (MPFS) Final Rule provisions on new CMS processes for identifying Medicare Part D claims for 340B drugs. While the current scope may seem limited or not applicable to certain 340B covered entities, now is the most important time to evaluate the implications of these programs if expanded to all 340B drugs and all 340B covered entities in order to ensure that the concerns of 340B covered entities are appropriately addressed. <Read More> 

Read More

Clinical Insights: November 21st, 2025

New Drug/Vaccine Approval

Komzifti™ (ziftomenib) Capsules - New Drug Approval – November 13, 2025 – The Food and Drug Administration approved ziftomenib (Komzifti™, Kura Oncology, Inc.), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options. <Read More>

Kygevvi® (doxecitine and doxribtimine) Powder for Oral Solution - New Drug Approval –November 3, 2025 – The U.S. Food and Drug Administration (FDA) approved Kygevvi® (doxecitine and doxribtimine) powder to treat thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients who start to show symptoms when they are 12 years old or younger. Kygevvi® received Breakthrough Therapy Designation for this indication. <Read More> 

Lynkuet® (elinzanetant) Capsules - New Drug Approval – October 24, 2025 – Bayer announced the U.S. Food and Drug Administration (FDA) has approved Lynkuet® (elinzanetant) 60mg capsules, the first and only dual neurokinin (NK) targeted therapy, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, for the treatment of moderate to severe hot flashes due to menopause. <Read More>

Javadin™ (clonidine hydrochloride) Oral Solution - New Drug Approval – October 23, 2025 – Azurity Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Javadin™ (clonidine hydrochloride) oral solution, the only FDA-approved, immediate-release, ready-to-use oral liquid clonidine formulation for the treatment of hypertension in adult patients to lower blood pressure. <Read More> 

Epioxa™ (riboflavin 5’-phosphate) Ophthalmic Solution - New Drug Approval – October 17, 2025 - Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases, announced the U.S. Food and Drug Administration (FDA) approved its Epioxa™ HD / Epioxa™ (“Epioxa”) New Drug Application (NDA). Epioxa™ is a groundbreaking advancement in corneal cross-linking for the treatment of keratoconus, a rare, sight-threatening disease that is currently far too often undiagnosed and untreated. <Read More>

Ferabright™ (ferumoxytol) Injection - New Drug Approval – October 16, 2025 - Azurity Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Ferabright™ (ferumoxytol injection), the first and only iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier. <Read More> 

New Label Expansions

Elevidys® (delandistrogene moxeparvovec-rokl) Suspension for Intravenous Infusion – New Label Expansion – November 14, 2025 - Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, announced an update to the prescribing information for Elevidys® (delandistrogene moxeparvovec-rokl), the only approved gene therapy for Duchenne muscular dystrophy (DMD). <Read More>  

Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection – New Label Expansion – November 6, 2025 - Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). Darzalex Faspro® is the first and only approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma. <Read More> 

Caplyta® (lumateperone) Capsules – New Label Expansion – November 5, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) approved Caplyta® (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. <Read More> 

Linzess® (linaclotide) Capsules – New Label Expansion – November 4, 2025 - The U.S. Food and Drug Administration (FDA) has approved Linzess® (linaclotide) capsules for pediatric patients 7 years and older with irritable bowel syndrome with constipation (IBS-C). Linzess® is the first treatment approved for IBS-C in pediatric patients. <Read More> 

Stoboclo® (denosumab-bmwo) Injection – New Label Expansion – October 29, 2025 – Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated Stoboclo® (denosumab-bmwo) and Osenvelt® (denosumab-bmwo) as interchangeable biosimilars to the reference products Prolia® (denosumab) and Xgeva® (denosumab), respectively, for all approved indications. <Read More>

Conexxence® (denosumab-bnht) Injection – New Label Expansion – October 29, 2025 - Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced that the U.S. Food and Drug Administration (FDA) designated Conexxence® and Bomyntra® (denosumab-bnht) as interchangeable biosimilars to the reference products, Prolia® (denosumab) and Xgeva® (denosumab), respectively. <Read More> 

Winrevair™ (sotatercept) for Injection – New Label Expansion – October 24, 2025 - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. product label based on the Phase 3 ZENITH trial for Winrevair™ (sotatercept-csrk) for injection, 45mg, 60mg. Winrevair™, an activin signaling inhibitor, is now FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death. <Read More> 

Revuforj® (revumenib) Tablets – New Label Expansion – October 24, 2025 - Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj® (revumenib) for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. <Read More> 

Blenrep® (belantamab mafodotin-blmf) Injection – New Label Expansion – October 23, 2025 - GSK plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved Blenrep® (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent. <Read More> 

Omvoh® (mirikizumab-mrkz) Injection – New Label Expansion – October 23, 2025 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of Omvoh® (mirikizumab-mrkz) for subcutaneous use in adults with moderately to severely active ulcerative colitis (UC). <Read More> 

Gazyva® (obinutuzumab) Injection – New Label Expansion – October 17, 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 Gazyva® (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients. <Read More> 

New Drug Shortage

November 17, 2025

November 14, 2025

November 13, 2025

November 12, 2025

November 7, 2025

Updated Drug Shortage

November 18, 2025

November 17, 2025

November 14, 2025

November 13, 2025

November 10, 2025

New Drug Recall and Safety Alerts

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial by Fresenius Kabi – New Voluntary Recall – November 7, 2025 - Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL vial. This recall is being performed to the user level in the United States. <Read More> 

Potassium Chloride 20 mEq Injection by Otsuka ICU Medical LLC – New Voluntary Recall – November 3, 2025 – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq with NDC 0990-7074-26. <Read More> 

New Generic/Biosimilar Approval and Launch

Poherdy™ (pertuzumab-dpzb) Injection - New Perjeta® Biosimilar Approval – November 13, 2025 – The Food and Drug Administration approved Poherdy™ (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta® (pertuzumab, Genentech Inc.). This is the first approval of a biosimilar for Perjeta®. <Read More> 

Clinical and Pharmacy News

Government Shutdown Now Over as Federal Agencies Reopen and Employees Return to Work – November 13, 2025 – With the shutdown finally in the rearview mirror, the focus in the Senate is turning to an upcoming fight over health care, with Democrats hoping to regroup after splintering in the final stages of the showdown. Eight Senate Democrats broke ranks to reach a deal with Republicans to end the shutdown, dashing the party's effort to win an extension of expiring Affordable Care Act tax credits in return for their vote to reopen the government. Now, Democrats face a quick timeline to shift their strategy. <Read More> 

ADHD Medication Recalled Nationwide Because Users Aren’t Getting the Full Effect – November 11, 2025 – A popular ADHD medication is being recalled nationwide because its users won’t be able to get the full effect. According to the Food and Drug Administration, several lots of lisdexamfetamine dimesylate capsules, a generic form of Vyvanse®, are being recalled. The recall was announced Oct. 28. The Board of Pharmacy said the medication failed dissolution tests, writing, “Dissolution is important for drugs to be absorbed and have a physiological effect on the human body; they must be in solution. The impacted capsules would not be able to deliver an optimal level of medicine and may impact the therapeutic efficacy of the product.” <Read More> 

CMS Announces GENEROUS Model to Lower Medicaid Drug Prices – November 6, 2025 – CMS announced the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model, a new drug payment model that will aim to lower prescription drug spending in Medicaid and strengthen the program overall. The GENEROUS model, launching in 2026, will allow participating states to purchase drugs included in the pilot at prices in line with those in other nations, with a goal of increasing access to medications and improving health outcomes among Medicaid beneficiaries. The announcement adds to a recent flurry of Trump administration initiatives aimed at addressing high drug prices in the US, including the Most Favored Nation (MFN) executive order and subsequent drug pricing deals with Pfizer, AstraZeneca, Novo Nordisk, and Eli Lilly and Company. <Read More> 

Certain Obesity Drugs Will Cost as Little as $149 And Medicare Will Start Covering Them Under White House Deals – November 6, 2025 – Certain blockbuster obesity drugs will be available for as little as $149 per month and more Medicare enrollees will have access to them under two deals announced Thursday by the Trump administration.The arrangements with drugmakers Eli Lilly and Novo Nordisk, which President Donald Trump foreshadowed in remarks last month, are the latest in the administration’s efforts to lower drug prices. As part of the new deals, the drugmakers have also agreed to match prices to the lowest paid in peer nations for all their drugs in Medicaid as well as for the list prices when their medications first hit the market. They will also offer primary care medicines directly to consumers at discounted prices. <Read More> 

New Data Shows Local Pharmacy Shortages – November 5, 2025 – A new mapping tool from the National Community Pharmacists Association and University of Southern California shows a few  pharmacy shortage areas in the Tri-Cities. At least three suburban and five rural neighborhoods are considered lacking across Carter, Hawkins, Johnson, Sullivan, Unicoi and Washington counties. Southwest Virginia also has three shortage areas between Bristol and Abingdon. These regions are defined by how far people need to travel to reach the nearest pharmacy: more than 10 miles in rural areas, two miles in suburbs and one mile in urban neighborhoods. Community pharmacies are critical access points in their communities, said Dr. Ronna Hauser, senior vice president of policy and pharmacy affairs for the NCPA. <Read More> 

Evaluating Pediatric Medication Errors: A Feasibility Study – November 5, 2025 - In a groundbreaking study published in BMC Pediatrics, researchers have delved into a critical yet often overlooked aspect of pediatric healthcare: medication discrepancies. The research conducted by an experienced team, including Mercümek, Bektay, and Uzuner, among others, sheds light on the alarming inconsistencies that can occur in the medication administered to young patients. The objective of this study was to evaluate the occurrence of medication discrepancies within a pediatric ward, utilizing a novel framework known as the Medication Discrepancy Taxonomy (MedTax). <Read More>  

AFPs Affect Access to Specialty Medications – October 30, 2025 - The use of alternative funding programs (AFPs) significantly reduces the likelihood of beneficiaries accessing needed medications, increases time to treatment, and is associated with more gaps in therapy and adverse clinical outcomes compared with traditional pharmacy benefits. Pharmacists at a dozen health systems presented these new results about AFPs—for-profit third-party vendors used by self-funded employer plans that carve out certain medications as “nonessential health benefits” and attempt to obtain medication from non-health plan sources—in a presentation at AMCP Nexus 2025, in National Harbor, Maryland (poster 138). <Read More> 

Many Unanswered Questions: Will the Trump Administration’s Drug Pricing Deals Result in Any Cost Savings for State Medicaid Programs? – October 29, 2025 - Over the last month, the White House has widely touted pricing agreements from two drug manufacturers — Pfizer and AstraZeneca — which it claims will result in substantial prescription drug cost savings for state Medicaid programs.  According to the White House, under these agreements, the manufacturers will provide “Most Favored Nation (MFN)” prices, based on lower international prices paid by other nations, to all state Medicaid programs.  This follows from a May 2025 executive order promoting MFN pricing. <Read More> 

EmblemHealth taps Prime Therapeutics, Amazon for new Pharmacy Benefit Collaboration – October 29, 2025 - New York-based insurer EmblemHealth is teaming up with Prime Therapeutics to rethink the pharmacy benefit experience for its members. Emblem will tap into Prime's tech stack, which allows real-time referrals for specialty drugs instead of the more traditional network structure. In this model, it encourages competitive pricing for specialty products when ensuring members feel the savings directly, the insurer said in an announcement. <Read More> 

340B in the News

Rage Over Rebates: Hospitals Oppose 340B Pilot Program – November 12, 2025 - The federal government is testing a new method of delivering discounts in a program aimed to help hospitals buy certain drugs at lower prices, and health systems aren’t happy about it. The government is testing a new pilot program that would move from hospitals simply buying the drugs at lower prices in the federal 340B Drug Discount Program. The Health Resources and Services Administration said late last month it’s testing a new program with eight companies that would offer rebates to hospitals after they have purchased the drugs. The agency said it is testing plans from large drug companies including Bristol Myers Squibb, Astra Zeneca, and Novo Nordisk Inc. The pilot program is slated to launch Jan. 1. <Read More> 

340B Rebate Models and Medicare Part D 340B Claims: What 340B Covered Entities Need to Know for 2026 – November 11, 2025 – 340B covered entities should carefully review the approved 340B rebate models and the 2026 Medicare Physician Fee Schedule (MPFS) Final Rule provisions on new CMS processes for identifying Medicare Part D claims for 340B drugs. While the current scope may seem limited or not applicable to certain 340B covered entities, now is the most important time to evaluate the implications of these programs if expanded to all 340B drugs and all 340B covered entities in order to ensure that the concerns of 340B covered entities are appropriately addressed. <Read More> 

Read More

Ready to get started?

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

Contact Us

Ready to get started?

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

Contact Us