Federal Register notice: FDA seeks comments on an information collection revision entitled Premarket Approval of Medical Devices.
Federal Register notice: FDA announces a 3/20 joint advisory committee meeting to review an NDA for proposed nonprescription nasal spray for use as an...
Several public health advocacy groups sue FDA, challenging its 2021 denial of a citizen petition that sought the withdrawal of medically important ant...
FDA posts a new funding opportunity for its Pediatric Device Consortia grants program, which is open for applications through 3/29.
Janssen Pharmaceutical says it will submit an NDA supplement for Carvykti (ciltacabtagene autoleucel; cilta-cel) after announcing favorable data from ...
Vanda Pharmaceuticals petitions FDA to revoke the approval of a Teva ANDA for a generic copy of Vandas Hetlioz (tasimelteon) because Tevas product fai...
FDA denies a 3/2021 petition filed by Loeb & Loeb that asked the agency to take specific actions concerning the adequacy of safety labeling for Incyte...
Democrat members of the House Energy and Commerce Committee vote Rep. Anna G. Eshoo (D-CA) as ranking Democrat on the Health Subcommittee.
