FDA approves a new indication for Vandas Fanapt to treat some adults with bipolar I disorder.
Representatives Eric Swalwell (D-CA) and Dan Crenshaw (R-TX) introduce bipartisan legislation to help address drug-gene interactions and to ensure tha...
FDA sends Contract Pharmaceuticals Limited a Form FDA-483 citing one observation after its Mississauga, Canada facility was inspected 10/2023.
Federal Register notice: FDA makes available a draft guidance entitled Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.
A new HHS white paper on drug shortage policies cites many steps FDA has taken and wants to take in the future.
FDA approves Abbotts TriClip, a transcatheter edge-to-edge repair system that is designed for treating tricuspid regurgitation.
The FDA Medical Device Development Tool program qualifies the University of California San Francisco Lethal Arrhythmia Database.
FDA approves Basilea Pharmaceuticas antibiotic Zevtera for three indications.
