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Catalyst Pharmaceuticals Announces FDA Acceptance of the Supplemental New Drug Application for FIRDAPSE® - Vimarsana News

Catalyst Pharmaceuticals Announces FDA Acceptance of the Supplemental New Drug Application for FIRDAPSE®

The sNDA Seeks to Increase the Indicated Maximum Daily Dose for FIRDAPSE to 100mg for the Treatment of Lambert-Eaton Myasthenic Syndrome U.S. FDA Assigned Target Action Date of June 4, 2024 CORAL...

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FDA Panel Votes Against Approval Of Intercept Pharma's Liver Disease Drug; Stock Down - Vimarsana News

FDA Panel Votes Against Approval Of Intercept Pharma's Liver Disease Drug; Stock Down

A panel of advisers to the U.S. Food and Drug Administration voted against approving Intercept Pharmaceuticals' (ICPT) investigational treatment for Nonalcoholic steatohepatitis, a serious progressive liver disease.

Intercept Pharma Slips 28% As FDA Panel Votes Against Liver Disease Drug - Vimarsana News

Intercept Pharma Slips 28% As FDA Panel Votes Against Liver Disease Drug

Intercept Pharmaceutics, Inc (ICPT) shares are down almost 28% on Monday, after an FDA advisory panel voted against Intercept's drug obeticholic acid for the treatment of nonalcoholic steatohepatitis, or NASH.

BioMarin Provides Update on FDA Review of ROCTAVIAN™ (Valoctocogene Roxaparvovec) Gene Therapy for Adults with Severe Hemophilia A - Vimarsana News

BioMarin Provides Update on FDA Review of ROCTAVIAN™ (Valoctocogene Roxaparvovec) Gene Therapy for Adults with Severe Hemophilia A

/PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today...