For Immediate Release: November 15, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Next week, the World Health Organization’s Member State Mechanism on Substandard and Falsified …
For Immediate Release: November 14, 2024 The U.S. Food and Drug Administration approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L …
For Immediate Release: October 29, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA responded to objections on the agency’s final rule that removed the authorized food …
For Immediate Release: October 25, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA updated the advisory for the outbreak of E. coli O157:H7. A specific ingredient has not …
FDA News Release FDA Collaborating with Federal Task Force to Accelerate Further Enforcement Actions For Immediate Release: October 22, 2024 Today, the U.S. Food and Drug Administration, in collaboration with U.S. Customs and Border Protection (CBP), …
For Immediate Release: October 18, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: This week, FDA continues ongoing efforts to increase access and supply of IV and peritoneal dialysis ( …
For Immediate Release: October 15, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA’s Center for Drug Evaluation and Research (CDER) released the 2024 Accelerating Rare …
For Immediate Release: December 10, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced that, on January 1, 2025, the FDA will open the Voluntary Qualified Importer …
For Immediate Release: October 11, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA has issued an immediately-in-effect guidance, Temporary Policies for Compounding …
FDA News Release Product is First Non-Factor and Once-Weekly Treatment for Hemophilia B For Immediate Release: October 11, 2024 Today, the U.S. Food and Drug Administration approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce …
For Immediate Release: September 27, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA updated the Mycotoxins in Domestic and Imported Human Foods Compliance Program …
For Immediate Release: September 26, 2024 Today, the U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to …
For Immediate Release: September 24, 2024 Today, the U.S. Food and Drug Administration approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease type C (NPC) in adults and pediatric patients …
For Immediate Release: September 24, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA held a ribbon-cutting ceremony to highlight the completion of the 64,000 square foot …
For Immediate Release: September 20, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA and NIH announced “Advancing Smoking Cessation: FDA and NIH Priorities” – a joint …
FDA News Release First Influenza Vaccine That Does Not Need to be Administered by a Health Care Provider For Immediate Release: September 20, 2024 Today, the U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist …
For Immediate Release: September 20, 2024 Today, the U.S. Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). Miplyffa, in combination with the enzyme inhibitor miglustat …
For Immediate Release: September 17, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and …
For Immediate Release: September 16, 2024 Today, the U.S. Food and Drug Administration issued a draft guidance for industry that, when finalized, will provide sponsors with recommendations for conducting multiregional clinical trials (MRCT) in support of …
For Immediate Release: September 13, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA published the FDA Voices: “Join FDA for the First National Hispanic/Latino …
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