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Drug Approval Process

European Medicines Agency FDA Regulations Orphan Drug Designation Eli Lilly Global Regulatory Submissions Clinical Trial Regulations Clinical Study Results Global Regulatory Authorities Clinical Trials NHS Approval

Roche Files MS Drug Fenebrutinib With Regulators Despite Trial Deaths

Regulators now weigh relapse benefits against infection-linked fatalities in trials.

AstraZeneca’s Tozorakimab Hits Phase III Goal in COPD, Marking Third Positive Pivotal Trial

DBV Technologies Files 2025 Annual Report, Extends Runway as 2026 Peanut Patch Filings Near

Semaglutide Patent Expires in Brazil, Opening Door to Lower-Cost Rivals

EMA Backs First Combined COVID-19 and Flu Vaccine for Over-50s in EU

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

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

EMA Panel Backs Waskyra Gene Therapy for Wiskott‑Aldrich Syndrome

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

Enhertu Delivers Pivotal Gains in Early HER2-Positive Breast Cancer

CHMP Recommends Approval of Wayrilz for Refractory ITP in Adults

FDA Clears Shot Version of Keytruda as EU Panel Backs Approval

Mounjaro Rivals Trulicity in Cardiovascular Safety and Lowers All-Cause Mortality

AstraZeneca’s Baxdrostat Delivers Significant Blood Pressure Reductions in Phase 3 Trial for Resistant Hypertension

France Advances Medical Cannabis Legalization with Key Regulatory Step

Cassava Sciences Halts Alzheimer’s Drug Trials Following Phase 3 Failure