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July 17, 2026 15:14 ET | Source: FDA

FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol

Silver Spring, MD, July 17, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9...
July 10, 2026 10:46 ET | Source: FDA

FDA Proposes Rule to Modernize Drug Manufacturing Registration

Silver Spring, MD, July 10, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for...
July 01, 2026 18:17 ET | Source: FDA

FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease

Silver Spring, MD, July 01, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and...
July 01, 2026 13:36 ET | Source: FDA

FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients

Silver Spring, MD, July 01, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today approved Tregzi, the first regulatory T (Treg) cell-based immunotherapy for improving chronic...
June 26, 2026 11:33 ET | Source: FDA

FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health

Silver Spring, MD, June 26, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would help protect the public health of Americans,...
June 18, 2026 08:56 ET | Source: FDA

FDA Approves First Single-Dose Generic Treatment for Influenza

Silver Spring, MD, June 18, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment...
June 16, 2026 11:31 ET | Source: FDA

FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose

Silver Spring, MD, June 16, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram...
June 09, 2026 11:37 ET | Source: FDA

FDA Expands Sunscreen Options for the First Time in 20 Years

Silver Spring, Md., June 09, 2026 (GLOBE NEWSWIRE) -- Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant...
June 02, 2026 11:01 ET | Source: FDA

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

Silver Spring, MD, June 02, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more...
May 29, 2026 13:47 ET | Source: FDA

FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs

Silver Spring, Md., May 29, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for...