For Immediate Release: March 21, 2024 Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first …
For Immediate Release: March 19, 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 provided an update on our evaluation of quality and performance issues related to plastic …
For Immediate Release: March 18, 2024 Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic …
For Immediate Release: March 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 published its new paper, “Artificial Intelligence and Medical Products: How CBER, CDER, …
For Immediate Release: March 14, 2024 Today, the U.S. Food and Drug Administration approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), to be …
For Immediate Release: March 12, 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and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued the draft guidance Select Updates for the Premarket Cybersecurity Guidance: …
For Immediate Release: March 11, 2024 Today, the U.S. Food and Drug Administration (FDA) announced it is requesting $7.2 billion as part of the President’s fiscal year (FY) 2025 proposed budget. This funding will allow the agency to enhance food safety and …
For Immediate Release: August 30, 2024 English Hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) otorgó una autorización de uso de emergencia (EUA, por sus siglas en inglés) para una versión …
For Immediate Release: March 08, 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 proposed new regulations to provide animal drug sponsors with predictable …
For Immediate Release: March 08, 2024 Today, the U.S. Food and Drug Administration approved a new indication for use for Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular …
For Immediate Release: March 06, 2024 The U.S. Food and Drug Administration is taking several additional steps to address concerns about elevated lead levels in cinnamon following the recent incident associated with certain cinnamon apple sauce pouches …
For Immediate Release: March 05, 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 the availability of a final guidance for industry titled “Dietary Supplements: …
For Immediate Release: March 05, 2024 Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for …
For Immediate Release: May 03, 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 the availability of draft guidance for industry (GFI) #290 (VICH GL61) entitled “ …
For Immediate Release: April 03, 2024 Today, the U.S. Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including …
FDA News Release The following is attributed to Jim Jones, Deputy Commissioner for Human Foods For Immediate Release: February 28, 2024 Today, the U.S. Food and Drug Administration is announcing that grease-proofing materials containing per- and …
For Immediate Release: February 27, 2024 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 that on May 16, 2024, the FDA’s Vaccines and Related Biological Products …
For Immediate Release: February 23, 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 its final decision to withdraw approval of Pepaxto (melphalan flufenamide), …
For Immediate Release: February 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 published an interview with Dr. June Raine, CEO of the Medicines and Healthcare …
For Immediate Release: February 16, 2024 Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery …
