FDA lifts a partial clinical hold on PTC Therapeutics PTC518 for treating Huntingtons disease based on the agencys review of Phase 2 trial data (PIVOT...
FDA approves changes to the REMS for Kites lymphoma treatments Yescarta and Tecartus.
FDA releases the form FDA-483 issued with four observations following an inspection at the Dr. Reddys active pharmaceutical ingredient manufacturing f...
FDA publishes a guidance describing the behaviors the agency sees as delaying, denying, limiting, or refusing a drug or device inspection.
FDA issues a draft guidance indicating that it is moving away from recommending switching studies to support an interchangeability determination for b...
Federal Register notice: FDA withdraws approval of 20 ANDAs from multiple applicants after they notified the agency that the drug products were no lon...
Jazz Pharmaceuticals says data from its Phase 2b clinical trial evaluating the efficacy and safety of suvecaltamide in adult patients with essential t...
Johnson & Johnson asks FDA to approve a new indication for its Tremfya to treat some adults with Crohns disease.
