Category Regulatory

Scholar Rock Announces FDA Approval of ISEMBYLD™ for Spinal Muscular Atrophy

Scholar Rock Wins FDA Approval for ISEMBYLD, First Muscle-Targeted Treatment for Spinal Muscular Atrophy Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company focused on developing therapies for rare, severe and debilitating neuromuscular diseases through its expertise in myostatin biology, announced…

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Mirum Pharmaceuticals Appoints Dr. Rob Myers as Chief Medical Officer

Mirum Pharmaceuticals Appoints Rob Myers, M.D. as Chief Medical Officer to Lead Global Medical and Clinical Development Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a rare disease-focused pharmaceutical company developing medicines for patients with serious and often underserved conditions, has announced the…

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Prilenia Appoints Frederick (Rick) Munschauer, MD, FAAN, as Chief Medical Officer

Prilenia Therapeutics Appoints Neurology Expert Rick Munschauer as Chief Medical Officer Prilenia Therapeutics B.V., a biopharmaceutical company focused on developing potential treatments for neurodegenerative diseases, has announced the appointment of Frederick (Rick) E. Munschauer III, MD, MSc, FAAN, as its…

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ZANVASTRO™ (Zilganersen) Receives FDA Approval as First and Only Disease-Modifying Treatment for Alexander Disease in Pediatric and Adult Patients

Ionis Pharmaceuticals Receives FDA Approval for ZANVASTRO, First Disease-Modifying Treatment for Alexander Disease Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) has announced that the U.S. Food and Drug Administration (FDA) has approved ZANVASTRO™ (zilganersen) for the treatment of pediatric and adult patients…

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BeOne Medicines Receives FDA Approval for TEVIMBRA-Based First-Line HER2+ GEA Regimen

BeOne Medicines Receives FDA Approval for TEVIMBRA Combination in First-Line HER2-Positive Gastroesophageal Cancer BeOne Medicines Ltd., a global oncology-focused biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for TEVIMBRA®…

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Daiichi Sankyo Appoints Ken Keller as Chief Commercialization Officer to Drive Growth of Innovative Portfolio

Daiichi Sankyo Appoints Ken Keller as Chief Commercialization Officer to Accelerate Global Oncology and Specialty Medicine Growth Daiichi Sankyo has announced the appointment of Ken Keller to the newly created position of Chief Commercialization Officer, marking a significant step in…

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ORZEYFUL (oveporexton) Receives Japanese Approval as the First and Only Treatment Targeting the Underlying Cause of Narcolepsy Type 1

ORZEYFUL (oveporexton) Gains Japanese Approval as the First and Only Medicine Addressing the Underlying Cause of Narcolepsy Type 1 Takeda has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved ORZEYFUL (oveporexton) for the treatment of adults…

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