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CDRH reports on its 2025 MDUFA 5 activities to promote international harmonization.[ Price : $8.95]
A Congressional Research Service backgrounder explains options Congress could consider to resolve some issues with the skinny labe...[ Price : $8.95]
FDA accepts for review a Summit Therapeutics BLA seeking approval for ivonescimab in combination with chemotherapy in patients wit...[ Price : $8.95]
University of Southern California public policy professor Genevieve Kanter airs concerns about the impact of the many changes that...[ Price : $8.95]
Faced with a legal deadline for a response, FDA denies without comment on the specifics a law firms petition seeking restrictions ...[ Price : $8.95]
The CDRH 2025 annual report says the Center authorized 124 novel medical devices last year, one of the highest numbers of authoriz...[ Price : $8.95]
FDA places clinical holds on two Regenxbio investigational gene therapy programs for ultra-rare pediatric diseases following the i...[ Price : $8.95]
Boehringer Ingelheim says its investigational kidney drug apecotrep reduced proteinuria by 40% compared with placebo in a Phase 2 ...