Category Regulatory

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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Stuart Therapeutics Appoints David Jakeman as Chief Financial Officer

Stuart Therapeutics Appoints David Jakeman as Chief Financial Officer to Support Late-Stage Development and Commercialization Plans Stuart Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing first-in-class collagen-reparative therapeutics for ophthalmic diseases, has announced the appointment of David Jakeman as…

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Nanochon Receives Panama Approval to Begin First-in-Human Chondrograft™ Clinical Trial

Nanochon Secures Panamá Health Ministry Approval to Begin First-in-Human Chondrograft™ Clinical Study Radiation Detection Company (RDC), a long-established provider of occupational radiation dosimetry services, has announced the launch of Radiant, a real-time electronic dosimetry solution designed to provide healthcare professionals…

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FDA Approves LEROCHOL® Autoinjector and Expands Its Indication

FDA Approves LEROCHOL Autoinjector for Once-Monthly Self-Administration in Patients With High Cholesterol LIB Therapeutics, Inc. (LIB), a privately held biopharmaceutical company focused on helping high-risk patients achieve and maintain recommended cholesterol levels, announced that the U.S. Food and Drug Administration…

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FDA Grants Accelerated Approval to Bristol Myers Squibb’s ZENBEXUS™ for Multiple Myeloma

U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb’s ZENBEXUS™ in Combination Therapy for Multiple Myeloma at First Relapse Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has approved ZENBEXUS™ (iberdomide) in combination with daratumumab…

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Clinilabs Expands Leadership Team, Appoints Laura Shannon as CEO and Promotes Founder Gary Zammit, Ph.D. to Executive Chairperson

Clinilabs Expands Leadership Team With Laura Shannon as CEO as Founder Gary Zammit Moves to Executive Chairperson Clinilabs, a specialty contract research organization (CRO) focused on the development of central nervous system (CNS) drugs and medical devices, has announced an…

Read MoreClinilabs Expands Leadership Team, Appoints Laura Shannon as CEO and Promotes Founder Gary Zammit, Ph.D. to Executive Chairperson