Three stakeholders raise concerns about an FDA draft guidance on considerations for generating clinical evidence from multiregional clinical developme...
Merck reports positive topline results from a trial that evaluated the noninferiority of subcutaneous administration of Keytruda (pembrolizumab) versu...
FDA seeks input 11/21 from its Cellular, Tissue, and Gene Therapies Advisory Committee about AstraZenecas Andexxa and an increased risk of thrombosis ...
GSK says its Phase 3 GLISTEN trial evaluating linerixibat in adults with a relentless itch associated with primary biliary cholangitis met its primary...
FDA posts a draft guidance entitled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products.
FDA accepts for review an Aldeyra Therapeutics NDA for reproxalap, an investigational topical new drug candidate for treating signs and symptoms of dr...
FDA clears a BrightHeart 510(k) for its artificial intelligence software for reviewing prenatal ultrasound evaluations of the fetal heart to detect co...
FDA issues Takeda Pharmaceutical a four-item Form FDA-483 after inspecting the firms Yamaguchi, Japan manufacturing facility and finding GMP deficienc...
