CDRH reports on its 2025 MDUFA 5 activities to promote international harmonization.
A Congressional Research Service backgrounder explains options Congress could consider to resolve some issues with the skinny label provision in the W...
FDA accepts for review a Summit Therapeutics BLA seeking approval for ivonescimab in combination with chemotherapy in patients with epidermal growth f...
University of Southern California public policy professor Genevieve Kanter airs concerns about the impact of the many changes that have occurred at FD...
Faced with a legal deadline for a response, FDA denies without comment on the specifics a law firms petition seeking restrictions on approval of gener...
The CDRH 2025 annual report says the Center authorized 124 novel medical devices last year, one of the highest numbers of authorizations in history.
FDA places clinical holds on two Regenxbio investigational gene therapy programs for ultra-rare pediatric diseases following the identification of a c...
Boehringer Ingelheim says its investigational kidney drug apecotrep reduced proteinuria by 40% compared with placebo in a Phase 2 clinical trial invol...
