Pharmaceutical
FDA MedWatch Drug Alerts
- 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…
- Audience: Consumer, Pharmacy March 11, 2025 — FDA is alerting the public and industry to the results of new agency testing of 95 acne products containing benzoyl peroxide for possible benzene contamination. FDA has concluded that a limited number…
- Audience: Patient, Health Professional, Pharmacy, Immunology March 10, 2025 — As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the…
New Drug Approvals
- 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…
- INCHEON, South Korea, April 14, 2025 /– Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated Yuflyma (adalimumab-aaty), as an interchangeable biosimilar to Humira (adalimumab). Yuflyma is an FDA-approved…
- PRINCETON, N.J.–(BUSINESS WIRE) April 11, 2025 — Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment for adult…
- BRIDGEWATER, New Jersey and BENGALURU, Karnataka, India, April 10, 2025 — Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (U.S. FDA) has approved…
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
- 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…
- 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…
- BOSTON–(BUSINESS WIRE) April 14, 2025 — Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases, today announced…
- NEW YORK–(BUSINESS WIRE) April 14, 2025 — Pfizer Inc. (NYSE: PFE) today announced the decision to discontinue development of danuglipron (PF-06882961), an oral glucagon-like peptide-1 (GLP-1) receptor agonist, which was being investigated for…
Daily Med News
- SUNDAY, April 20, 2025 — When a child tumbles to the floor from a blow to the head, a parent's inner alarms should sound. The child may have a brain injury. Here's what parents need to know:What is a concussion?A concussion is a mild traumatic b…
- SATURDAY, April 19, 2025 — Three months after wildfires tore through Los Angeles, a new study offers insight into the lasting needs of fire survivors. Researchers from UC Davis School of Medicine said their findings from earlier wildfires…
- FRIDAY, April 18, 2025 — A new pill designed to help with weight loss and blood sugar control is showing promise in early studies. Eli Lilly said its experimental drug, orforglipron, helped people with type 2 diabetes lower their blood sugar…
- FRIDAY, April 18, 2025 — The Trump administration is weighing a plan to cut nearly a third of the federal health budget and eliminate or consolidate dozens of programs. An internal memo was sent from White House budget officials to the U.S…
- FRIDAY, April 18, 2025 — A federal team responsible for setting poverty guidelines that determine who qualifies for health and food assistance has been fired, according to former employees. The Department of Health and Human Services (HHS)…
News for Health Professionals
- FRIDAY, April 18, 2025 — Midafternoon dosing with beclomethasone dipropionate is associated with better clinical outcomes in mild-to-moderate atopic asthma, according to a study published online April 15 in Thorax. Ran Wang, Ph.D., from the NIHR…
- FRIDAY, April 18, 2025 — During 2018 to 2022, pregnancy-related deaths in the United States increased, according to a study published online April 9 in JAMA Network Open. Yingxi Chen, M.D., Ph.D., from the National Cancer Institute in Rockville…
- FRIDAY, April 18, 2025 — Individuals seeking acute care for cannabis use have an increased risk for a new dementia diagnosis compared with those with all-cause hospital-based care or the general population, according to a study published online…
- FRIDAY, April 18, 2025 — In a guideline issued by the U.S. Cystic Fibrosis Foundation and published online April 2 in the International Journal of Neonatal Screening, recommendations are presented to improve sensitivity, equity, and timeliness of…
- FRIDAY, April 18, 2025 — Patterns of mortality and end-of-life care have changed among U.S. ischemic stroke patients, with increases in mortality seen across all urbanization levels, especially in nonmetropolitan areas, according to a study…
