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.
CDRH releases a list of 11 final and draft guidances it plans to issue in FY 2026 if resources permit.
FDA commissioner Marty Makary tells employees affected by the government shutdown that the agency will continue mission-critical activities necessary ...
AbbVie files a BLA seeking approval for its investigational antibody-drug conjugate pivekimab sunirine to treat blastic plasmacytoid dendritic cell ne...
