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Federal Register notice: FDA makes available a draft guidance entitled New Dietary Ingredient Notification Master Files for Dietary Supplements.
Smiths Medical recalls its PneuPac paraPAC Plus 300 and 310 Ventilator Kits after receiving reports that the device may malfunction.
A Sidley petition comment response asks FDA to disregard comments on Sidleys orphan drug exclusivity petition made by former FDA orphan drug product d...
