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- Top FDA gene and cell therapy regulator to step downFollowing Vijay Kumar’s exit, acting CBER Director Karim Mikhail will also oversee a review office that has become a battleground for debates on FDA flexibility.BioPharma Dive · 1mo ago↗ source
- FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug ManufacturingFDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufac…fda press · 1mo ago↗ source
- Theravance, after clinical setbacks, agrees to $929M buyoutThe acquisition by royalty management company Zymeworks follows a "strategic review" triggered by the failure of a drug for a type of low blood pressure.