Pharmaceutical
FDA MedWatch Drug Alerts
- Audience: Health Care Providers, Compounders, Consumers April 22, 2025 — FDA has become aware of reports of adverse events involving compounded topical finasteride products potentially putting consumers at risk. The agency is aware of some…
- Audience: Consumer, Health Professional, Pharmacy April 18, 2025 — Bridgewater, NJ, Amneal Pharmaceutical LLC, is recalling two lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags to the hospital/user level as the products…
- Audience: Consumers April 14, 2025 — FDA was notified by Novo Nordisk on April 3, 2025, that several hundred units of counterfeit Ozempic (semaglutide) injection 1 mg were in the U.S. drug supply chain. The counterfeit products were distributed…
- Audience: Consumer, Health Professional, Pulmonology March 14, 2025 — FDA advises consumers not to inhale nitrous oxide products from any size canisters, tanks, or chargers. These products are marketed as both unflavored and flavored nitrous oxide…
- Audience: Pharmacy, Health Care Professional March 13, 2025 — Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”), is…
New Drug Approvals
- TARRYTOWN, N.Y. and PARIS, April 18, 2025 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adults…
- PRINCETON, N.J.– April 17, 2025 — (BUSINESS WIRE)– Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has updated the U.S. Prescribing Information for Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg…
- Milan, Italy and Bridgewater, NJ, April 16, 2025 – Today Recordati announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Isturisa (osilodrostat) for the treatment of endogenous…
- San Diego, CA – April, 16, 2025 – Neurelis, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Valtoco (diazepam nasal spray) for short-term treatment of seizure clusters (also known as “acute…
- FOSTER CITY, Calif.–(BUSINESS WIRE) April 14, 2025 — Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of Livmarli (maralixibat) for the treatment of…
New Drug Applications
- LEXINGTON, Mass.–(BUSINESS WIRE)–Apr. 3, 2025– Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today…
- WASHINGTON, March 31, 2025 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of…
- PRINCETON, N.J. and TOKYO, JAPAN March 31, 2025 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce the filing of a Biologics License Application (BLA) with the U.S…
- MONTREAL and CHARLOTTE, N.C., March 28, 2025 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug…
- CAMBRIDGE, Mass.–(BUSINESS WIRE)–Mar. 25, 2025– Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases…
Clinical Trial Results
- PRINCETON, N.J.–(BUSINESS WIRE) Apr 22, 2025 — Bristol Myers Squibb (NYSE: BMY) today announced topline results from the Phase 3 ARISE trial evaluating the efficacy and safety of Cobenfy (xanomeline and trospium chloride) as an adjunctive…
- INDIANAPOLIS, April 17, 2025 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced positive topline Phase 3 results from ACHIEVE-1, evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and…
- Cambridge MA, USA, April 16, 2025 – BlueRock Therapeutics LP, a clinical-stage cell therapy company and wholly owned subsidiary of Bayer AG, today announced the publication of the 18-month data from its Phase 1 exPDite clinical trial for…
- Tuesday, April 15, 2025 — New studies in rats suggest the drug reserpine, approved in 1955 for high blood pressure, might treat the blinding disease retinitis pigmentosa. No therapy exists for this rare inherited disease, which starts affecting…
- DURHAM, N.C.–(BUSINESS WIRE)–Apr. 15, 2025– Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with high…
Daily Med News
- THURSDAY, April 24, 2025 — The U.S. Department of Health and Human Services and the U.S. Food and Drug Administration have released further details of their plans to remove all petroleum-based synthetic dyes from the nation's food supply."Today…
- THURSDAY, April 24, 2025 — A quick spray of medication might seem like an easy way to get thicker hair, but some people say one sold online has left them battling sexual side effects, depression and even thoughts of suicide. Now, the U.S…
- THURSDAY, April 24, 2025 (Health Day News) — Fewer babies are being born in the U.S., and experts are worried what that portends for the future. The number of babies born in the U.S. rose slightly in 2024, the fertility rate remains below…
- THURSDAY, April 24, 2025 — The United States is now experiencing its largest measles outbreak since the disease was declared eliminated in 2000, federal scientists confirmed this week. At least 800 measles cases have been reported nationwide…
- THURSDAY, April 24, 2025 — Treating anemia during pregnancy might lower the risk of heart defects in newborns, a new study says. Women with anemia in early pregnancy have a 47% increased risk of giving birth to a child with a heart defect…
News for Health Professionals
- THURSDAY, April 24, 2025 — The sex-based differences in past-month binge drinking among young adults reversed in 2021-2023 versus 2017-2019, with higher rates emerging among women, according to a research letter published online April 16 in the…
- THURSDAY, April 24, 2025 — A single-dose baloxavir treatment can reduce influenza transmission from index patients to household contacts, according to a study published in the April 24 issue of the New England Journal of Medicine. Arnold S. Monto…
- THURSDAY, April 24, 2025 — School-based asthma therapy (SBAT) can help improve children’s asthma control and decrease acute health care utilization, according to a study published in the May issue of the Journal of Allergy and Clinical…
- THURSDAY, April 24, 2025 — Different measurement tools and diagnostic criteria show low-to-moderate agreement for diagnosing breast cancer-related lymphedema (BCRL), according to a study published in the April issue of Rehabilitation…
- THURSDAY, April 24, 2025 — Metabolic syndrome (MetS) and its individual components are associated with an increased risk for young-onset dementia (YOD), according to a study published online April 23 in Neurology. Jeong-Yoon Lee, M.D., from…
