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Drug Approval Process

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Sanofi’s Venglustat Notches Gaucher Type 3 Phase 3 Win, Misses Fabry Pain Endpoint

Sanofi plans regulatory discussions on the Gaucher data with fuller results to be presented at an upcoming medical meeting.

EMA Panel Backs Conditional EU Approval for Rezurock in Chronic GvHD

EU Regulator Backs Myqorzo for Obstructive Hypertrophic Cardiomyopathy

Ianalumab Plus Eltrombopag Extends Disease Control in Phase 3 ITP Study Published in NEJM

Dyne’s DMD Drug Hits Primary Endpoint in DELIVER REC, Shows Functional Gains

Belite Bio’s Tinlarebant Cuts Stargardt Lesion Growth 36% in Phase 3 Trial

Padcev–Keytruda Cuts Recurrence and Death Risk in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer