FDA sets the rates and payment procedures for fiscal year 2024 generic new animal drug program user fees.
Federal Register notice: FDA announces the rates and payment procedures for fiscal year 2024 animal drug user fees.
FDA approves a Celltrion BLA for Zymfentra (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active ulcerative colitis a...
FDA issues Panacea Biotec Pharma a nine-item Form FDA-483 after inspecting the firms Himachal Pradesh, India manufacturing 10/3-12.
ImmunityBio refiles its BLA for Anktiva (N-803) in combination with Bacillus Calmette-Gurin (BCG) for treating patients with BCG-unresponsive non-musc...
Merck says its Keytruda (pembrolizumab) plus concurrent chemoradiotherapy reduced the risk of disease progression or death by 30% compared to concurre...
Federal Register notice: FDA makes available a final guidance entitled Benefit-Risk Assessment for Human Drug and Biological Products.
FDA approves a Shockwave Medical PMA for what the company calls an enhanced Shockwave C2+ Coronary Intravascular Lithotripsy catheter.
