For Immediate Release: September 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and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued the draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar …
For Immediate Release: September 15, 2023 Today, the U.S. Food and Drug Administration announced it is taking new steps to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products, to increase …
FDA News Release Agency Warns Eight Companies Regarding Their Unapproved Ophthalmic Drugs For Immediate Release: September 12, 2023 The U.S. Food and Drug Administration has issued warning letters to eight companies for manufacturing or marketing …
For Immediate Release: September 11, 2023 Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better …
For Immediate Release: November 09, 2023 Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus. …
For Immediate Release: November 09, 2023 Today, the U.S. Food and Drug Administration approved Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme replacement therapy (ERT) in …
For Immediate Release: November 09, 2023 Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for …
For Immediate Release: August 30, 2023 Today, the U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that the industry is …
For Immediate Release: August 29, 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 informed consumers in Treating and Dealing with ADHD about FDA-approved treatments …
For Immediate Release: August 25, 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 the signing of a first-of-its kind Regulatory Partnership Arrangement with …
For Immediate Release: August 24, 2023 The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). …
For Immediate Release: August 23, 2023 Today, the U.S. Food and Drug Administration is announcing the selection of James “Jim” Jones to serve as the first Deputy Commissioner for Human Foods. The new executive position will lead the charge in setting and …
For Immediate Release: August 21, 2023 Today, the U.S. Food and Drug Administration approved Abrysvo (Respiratory Syncytial Virus Vaccine), the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and …
For Immediate Release: August 18, 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 provided an update to the list of ultraviolet (UV) wand products that may present …
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 …
