The U.S. District Court for Southern Florida enters a consent decree of permanent injunction against LGM Pharma and two of the company's executives.
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.
