In a delayed report to Congress, CDRH says it issued 45 medical device safety communications of various types in 2022.
FDA says the Medos International Srl recall of the Cerenovus Cerebase DA guide sheath is Class 1.
Liquidia says it believes there no longer are legal bars on FDA approving its Yutrepia inhalation powder for two indications.
Novartis says it will seek FDA approval for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for slowing disease progression in pa...
Hogan Lovells attorneys say FDA may create new Centers of Excellence as it works to regulate AI in medical product development through cross-Center co...
The House Committee on Oversight and Accountability ratchets up political pressure on FDA by requesting commissioner Robert Califfs testimony at a 4/1...
Amylyx Pharmaceuticals withdraws the approval of its amyotrophic lateral sclerosis drug Relyvrio (sodium phenylbutyrate and taurursodiol) after Phase ...
Federal Register notice: FDA makes available a draft guidance entitled New Dietary Ingredient Notification Master Files for Dietary Supplements.
