For Immediate Release: August 15, 2023 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 a request for information on a citizen petition asking the FDA to amend the …
For Immediate Release: August 11, 2023 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 issued an Outbreak Advisory for an investigation of Listeria monocytogenes …
For Immediate Release: December 08, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Wednesday, the FDA announced that eSTAR is now available for voluntary use for certain PMA …
For Immediate Release: December 08, 2023 Today, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 …
For Immediate Release: November 08, 2023 Today, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity (body mass index of 30 kilograms per square meter (kg/ m2) or greater) or …
For Immediate Release: September 08, 2023 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’s Center for Devices and Radiological Health (CDRH) published a Postmarket …
For Immediate Release: August 08, 2023 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 it is issuing a direct final rule to complete administrative actions that …
For Immediate Release: August 04, 2023 El día de hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) aprobó Zurzuvae (zuranolona), el primer medicamento oral indicado para tratar la depresión posparto ( …
For Immediate Release: July 28, 2023 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 approved Ervebo, a vaccine for the prevention of Ebola virus disease caused by Zaire …
For Immediate Release: July 28, 2023 Today, the U.S. Food and Drug Administration approved RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use for the emergency treatment of known or suspected opioid …
For Immediate Release: July 27, 2023 Today, the U.S. Food and Drug Administration announced new steps to help facilitate innovation in devices intended to treat opioid use disorder (OUD). The draft guidance, to help sponsors design clinical studies to …
For Immediate Release: July 25, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA reopened the comment period for the 30-day procedural notice to conduct a study …
For Immediate Release: July 21, 2023 Statement From: Robert M. Califf, M.D., MACC Commissioner of Food and Drugs - Food and Drug Administration The U.S. Food and Drug Administration is working closely with Pfizer to assess the impact of the damage at …
For Immediate Release: July 21, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA Center for Tobacco Products (CTP) announced that the center will host a virtual listening …
For Immediate Release: July 18, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA announced the findings from the voluntary pilot program to evaluate alignment of …
For Immediate Release: July 17, 2023 Today, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering …
For Immediate Release: July 14, 2023 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 re-issued two temporary guidances originally published during the COVID-19 public …
For Immediate Release: July 13, 2023 Today, the U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription. …
For Immediate Release: July 11, 2023 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 Veterinary Medicine (CVM) detailed how it is working to stop illicit xylazine …
For Immediate Release: November 07, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA issued a Safety Communication warning consumers, health care providers, and health …
