Category Regulatory

FDA Approves Genentech’s Tecentriq Combination for Stage III Colon Cancer Adjuvant Treatment

Genentech’s Tecentriq Receives FDA Approval for Adjuvant Treatment of Stage III dMMR Colon Cancer Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and…

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Pfizer’s TUKYSA Regimen Wins FDA Approval for Front-Line Maintenance in HER2+ Metastatic Breast Cancer

FDA Approves Pfizer’s TUKYSA Regimen for First-Line Maintenance in HER2+ Metastatic Breast Cancer Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved TUKYSA® (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults…

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Shape Memory Medical Receives ANVISA Approval for IMPEDE Embolization Plug Family in Brazil

Shape Memory Medical Receives ANVISA Authorization for IMPEDE Embolization Plug Portfolio in Brazil Shape Memory Medical Inc., a medical technology company developing volume-expanding shape memory polymer solutions for endovascular embolization, has announced that Brazil’s national health surveillance agency, Agência Nacional…

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Argonaut Manufacturing Services Appoints J.D. Mowery to Board of Directors

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…

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Gardner Medical Instruments Receives FDA Registration for Ventubation™ System, Earns EMS EXPO Award Nomination

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…

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VB Spine Receives FDA Breakthrough Device Designation for Scoliosis Risk Blood Test

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…

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Meitheal Pharmaceuticals Announces FDA Approval of High-Concentration YUSIMRY Biosimilar to Humira

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.…

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