NeuroLife Appoints Christopher Coburn and Matthew Thomas to Board as Company Advances Neurotechnology Platform Appoints®, a neurotechnology company focused on developing non-invasive solutions to help restore function and independence for people living with stroke and spinal cord injury, has announced…
Argonaut Manufacturing Services Appoints J.D. Mowery to Board of Directors Argonaut Manufacturing Services (Argonaut), a U.S.-based contract development and manufacturing organization (CDMO) specializing in sterile fill-finish services for injectable biologics and pharmaceutical products, has announced the appointment of J.D. Mowery…
Gardner Medical Instruments Receives FDA Class I Registration for Ventubation Airway Management System Gardner Medical Instruments, LLC has announced that it has received U.S. Food and Drug Administration (FDA) Class I registration for its Ventubation™ System, a novel airway management…
VB Spine’s ScolimiR-3D Receives FDA Breakthrough Device Designation for Scoliosis Progression Risk Assessment VB Spine LLC, a privately held spine technology company, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to ScolimiR-3D, an in…
Meitheal Pharmaceuticals Announces FDA Approval of High-Concentration Interchangeable YUSIMRY Biosimilar to Humira Meitheal Pharmaceuticals, Inc., a Chicago-based fully integrated biopharmaceutical company focused on the development and commercialization of generic injectables, fertility products, biologics and branded medicines, announced that the U.S.…
Biodextris Appoints Clement Fourny as CEO to Lead Next Phase of Biologics CDMO Growth Biodextris, a Laval, Quebec-based biologics contract development and manufacturing organization (CDMO), has appointed Clement Fourny as its new chief executive officer. The leadership transition comes as…
Bayer’s Lynkuet Receives FDA Priority Review for Vasomotor Symptoms Associated With Breast Cancer Endocrine Therapy Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for Lynkuet® (elinzanetant) and granted the…
Alume Biosciences Receives FDA Breakthrough Therapy Designation for Bevonescein in Intraoperative Nerve Visualization Alume Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to bevonescein, an investigational fluorescent imaging agent being developed…
FDA Approves WELIREG Plus LENVIMA for Previously Treated Advanced Clear Cell Renal Cell Carcinoma Merck, known as MSD outside the United States and Canada, and Eisai announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG® (belzutifan) in…
New Paper Provides Roadmap for Using Real-World Data in FDA Drug Approvals and Label Expansions Slipstream, a technology consulting partner focused exclusively on the life sciences industry, has announced the publication of a new peer-reviewed paper addressing how pharmaceutical and…
ImmunoScape Appoints Peter Olagunju as CEO to Advance TCR-Based Cancer Immunotherapy Platform Toward the Clinic ImmunoScape Pte. Ltd., an A*STAR spin-out backed by Amgen Ventures and EDBI, has appointed Peter Olagunju as its new Chief Executive Officer as the biotechnology…
Merck’s KEYTRUDA QLEX Approved in Japan for Subcutaneous Use Across KEYTRUDA Indications Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved KEYTRUDA QLEX™ (pembrolizumab and…