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.
FDA clears a UroViu 510(k) for its UV5000 cordless, single-use endoscope platform.
FDA approves a Zoll Medical PMA for Zenix, the companys newest monitor/defibrillator, which the company says is designed to streamline emergency and h...
