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Drug Application

Torrent Pharma launches First and Only Generic Version of Keveyis Tablets in the United States

Torrent Pharma has begun shipping the generic version of Xeris's Keveyis (dichlorphenamide), 50mg tablets, following final approval from the U.S. Food and Drug Administration...

Neurocrine Biosciences Announces U.S. FDA Accepts Supplemental New Drug Application

Neurocrine Biosciences, Inc., a leading neuroscience-focused biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application...

Kala Pharmaceuticals Announces Submission of Investigational New Drug Application

Kala Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare diseases of the eye, announced...

Blueprint Medicines Submits Supplemental New Drug Application to FDA for AYVAKIT

Blueprint Medicines Corporation announced the submission of a supplemental new drug application to the U.S. Food and Drug Administration (FDA) for AYVAKIT® (avapritinib) for...

SCG Cell Therapy Announces U.S FDA Clearance of Investigational New Drug Application

Singapore-based SCG Cell Therapy Pte Ltd ("SCG") announced that U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for...
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