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...
The Washington Legal Foundation calls on the FDA to stop its broad crackdown on drug TV advertising, citing First Amendment protection for commercial ...
FDA releases a list of eight Generic Drug User Fee Act science and research priorities for FY 2026, covering 23 separate initiatives.
