The Latest Breaking News from FDA

Venezuela responds defiantly to Trump comments about closing airspace above country, saying it doesn’t accept foreign orders or threats

The Food and Drug Administration’s top vaccine regulator is pushing new limits on how vaccines win approval. The tougher standards could cloud prospects for vaccine makers and rattle investors in major healthcare and biotech names.

The Food and Drug Administration has long been associated with drug approvals and food safety, but its role in regulating medical technology is just as...

Lead FDA vaccine regulator announced new approval process after claiming Covid vaccine had killed 10 children

The internal memo comes after an internal agency review linked COVID-19 vaccines to the deaths of 10 children.

The FDA will also review its guidance for annual flu shots, according to a memo

Recall is the latest affecting cheese products

The U.S. Food Drug Administration (FDA) on Tuesday extended review for Ascendis Pharma A/S‘ (NASDAQ:ASND) New Drug Application (NDA) for TransCon CNP (navepegritide) for children with achondroplasia.

RFK Jr signed order withdrawing rule that would mandate testing for the cancer-linked toxin in talc-based makeup

The U.S. Food and Drug Administration’s (FDA) top official ignited fresh debate on Wednesday by accusing Dr Anthony Fauci on the “Pod Force One” podcast of suppressing early scrutiny of COVID-19’s origins, calling the alleged effort a “massive cover-up” during the first months of the pandemic.

On Wednesday, Novo Nordisk A/S (NYSE:NVO) submitted its supplemental marketing application to the U.S. Food and Drug Administration (FDA) for a higher dose of semaglutide injection 7.2 mg for chronic weight management.