Sanofi’s Venglustat Gains FDA Priority Review for GD3
PARIS, France, May 28, 2026 Sanofi has achieved a major regulatory milestone with the U.S. Food and Drug Administration...
breakthrough therapy
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Oculis Holding AG Secures FDA SPA for Privosegtor Optic Neuritis Phase 3 Trial
ZUG, Switzerland – May 7, 2026 Oculis Holding AG announced that the U.S. Food and Drug Administration (FDA) has...
HUTCHMED Advances Sovleplenib NDA for wAIHA in China
HONG KONG, SHANGHAI & FLORHAM PARK, N.J., April 29, 2026 HUTCHMED (China) Limited has announced that the New Drug...
Praxis Precision Medicines Gains FDA Priority Review Boost
BOSTON, March 30, 2026 Praxis Precision Medicines has achieved a major regulatory milestone as the U.S. Food and Drug...
Vir Completes Phase 3 Enrollment for Hepatitis Delta Trial
San Francisco, California – November 3, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), a clinical-stage biopharmaceutical company focused on harnessing...
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Sagimet Begins Phase 1 Trial of Denifanstat-Resmetirom Combo in MASH
SAN MATEO, Calif., Oct. 1, 2025 — Sagimet Biosciences announced that it has dosed the first participants in a...
FDA Grants Breakthrough Therapy Status to Olomorasib for Lung Cancer
INDIANAPOLIS, Sept. 4, 2025 – The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib,...
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