FDA Announces First Recipients of Makary’s National Priority Voucher Program, Expanding Scope for Accelerated Drug Reviews

FDA; National Priority Voucher; CNPV; Martin Makary; priority review; accelerated drug approval; 2025 pilot program; voucher recipients; public health crisis; domestic drug manufacturing

CHMP Rejects Sanofi’s Rezurock Over Clinical Data Issues, Recommends Approval of BTK Inhibitor Wayrilz

Sanofi; CHMP; EMA; Rezurock; Wayrilz; Belumosudil; Rilzabrutinib; chronic graft-versus-host disease; cGVHD; immune thrombocytopenia; ITP; regulatory approval; clinical data

EMD Serono Joins TrumpRx in Affordability Push; Roche Launches DTC Program

EMD Serono; TrumpRx; IVF therapies; affordability; fertility drugs; Direct-to-Consumer sales; Roche; DTC program; White House Executive Order; Section 232 tariffs; CNPV program; Pergoveris

White House Announces New Most-Favored Nation Drug Pricing Deal, Updates on FDA Vouchers and GLP-1 Negotiations

most-favored nation pricing; fertility drugs; IVF; Trump administration; drug pricing; Medicaid; FDA vouchers; GLP-1; EMD Serono; Pfizer; AstraZeneca

Ex-FDA Leaders Launch Canal Row Advisors, Offer Insights on Agency’s Challenges and Direction

Canal Row Advisors; FDA leadership; regulatory consulting; Michael Rogers; Hilary Marston; life sciences; regulatory strategy; public health; FDA reform; innovation policy

FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months

FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval