FDA grants Bristol Myers Squibb fast-track status for its investigational Alzheimers therapy BMS-986446.
FDA issues a report highlighting Sentinel System activities and achievements between 2022 and 2024.
FDA and Vanda agree to a series of actions to resolve their disputes over the companys Hetlioz and tradipitant.
A CDRH Learn module reviews the Quality Management System Regulation requirements for medical device manufacturers and the benefits that flow from fol...
FDA issues 17 new and 64 revised product-specific guidances to aid in developing generic drugs.
FDA grants Umoja Biopharma a fast track designation for its investigational therapy UB-VV111 for treating relapsed or refractory large B-cell lymphoma...
FDA issues a complete response letter to Fortress Biotech and its majority-owned subsidiary, Cyprium Therapeutics, regarding their Menkes disease drug...
FDA approves a Novartis NDA for Rhapsido (remibrutinib), a Brutons tyrosine kinase inhibitor for treating adults with chronic spontaneous urticaria.
