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Notizia - Recent Pharma, Healthcare and Biotech Happenings

SetPoint Medical Earns FDA Nod for First-of-Its-Kind Neuroimmune Modulation Therapy in RA; Body Vision Medical Secures Singapore Pre‑Market Approval for LungVision; BioLab Holdings Initiates Landmark Clinical Trial for Placental Membrane Therapies; Concept Medical Launches MAGICAL-SV IDE Trial; Frenova Enters Strategic Partnership to Push Boundaries in Kidney Precision Medicine; Demetra Acquires OrthoFundamentals and Establishes Global Spine Division

SetPoint Medical Received FDA Approval for Novel Neuroimmune Modulation Therapy for Rheumatoid Arthritis On July 31, 2025, SetPoint Medical, a company focused on developing therapies for individuals with chronic autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) approved its SetPoint System. This groundbreaking device is the first neuroimmune modulation system designed to treat adults with moderate-to-severe rheumatoid arthritis (RA) who have not responded adequately to or cannot tolerate current advanced RA treatments, including biologics and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs). “The approval of ...

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Sobi’s GAMIFANT Approved by FDA as First Treatment for Macrophage Activation Syndrome in Still’s Disease; GSK Cuts RTS,S Malaria Vaccine Price for Children in Endemic Regions to Under $5; Schrödinger’s SGR-1505 Receives FDA Fast Track Designation for Relapsed/Refractory Waldenström Macroglobulinemia; Ultragenyx’s GTX-102 Granted FDA Breakthrough Therapy Designation for Angelman Syndrome; Eli Lilly’s AMYVID Label Updated by FDA to Support Alzheimer’s Disease Diagnosis

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GE HealthCare Receives FDA Approval for Expanded Vizamyl PET Imaging Indications in Alzheimer’s Disease Care; FDA Grants Approval to InspireMD’s CGuard® Prime for Carotid Artery Disease; AngioDynamics Launches RECOVER-AV Trial, Marking Milestone in AlphaVac F18⁸⁵ Development for PE Treatment; Tivic Health Concludes Study Optimizing Non-Invasive Vagus Nerve Stimulation Device for Personalized Therapy; Johnson & Johnson Introduces VOLT™ Plating System and ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM in the U.S.

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Presidio Medical™ Gains IDE Nod for ULF™ Study, Names Dimas Jiménez CFO; Creo Medical Gains FDA Nod for SpydrBlade™ Flex, Paving Way for U.S. Launch; Penumbra Completes Patient Enrollment in Pivotal STORM-PE RCT; Adona Medical Completes Enrollment in First-in-Human Trial of Novel Interatrial Shunt for Heart Failure; Johnson & Johnson Launches TECNIS Odyssey Intraocular Lens in Europe, Middle East, and Canada for Enhanced Cataract Care; Philips Sets New Benchmark in POCUS Technology with Flash 5100 Launch

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Amylyx’s AMX0114 Fast Tracked by FDA for ALS; Cellectar’s Iopofosine I 131 Granted FDA Breakthrough in Waldenstrom Macroglobulinemia; YolTech’s YOLT-101 Clears FDA IND for Familial Hypercholesterolemia; Oncovita’s MVdeltaC Gets FDA Orphan Tag for Pleural Mesothelioma; Merck’s ENFLONSIA Approved for RSV Prevention in Infants

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Incyte’s ZYNYZ Approved as First-Line Treatment for Advanced Anal Cancer; Amneal Gets FDA Nod for BREKIYA for Migraines; FDA Accepts Travere’s sNDA for FILSPARI in FSGS; AbbVie’s EMRELIS Approved for Advanced NSCLC With High c-Met; Merck’s WELIREG Approved for Advanced PPGL in Patients 12+

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