FDA extends by three months its review of an Argenx BLA for subcutaneous efgartigimod for treating adult patients with generalized myasthenia gravis.
CDER and CBER say that beginning 2/13 they will restart limited in-person, face-to-face industry meetings.
Eleven-year Oracle veteran Troy Tazbaz joins FDA as Digital Health Center of Excellence director, replacing Bakul Patel who left the agency last May t...
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 ...
