FDA posts a revised draft guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of ...
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.
