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Federal Register notice: FDA makes available a draft guidance entitled New Dietary Ingredient Notification Master Files for Dietary Supplements.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...
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Federal Register notice: FDA makes available a draft guidance entitled Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.
