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Promising Efficacy and Safety of Fenebrutinib in Relapsing Multiple Sclerosis (RMS): Insights from Phase II Study FENopta

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Pharma News for Pfizer, Sarepta, FibroGen, Erasca

FDA Approves Jardiance for Type 2 Diabetes; FDA Approves Pfizer’s LITFULO for Alopecia Areata; Sarepta Therapeutics’s ELEVIDYS Approval; Tonix Pharmaceuticals to Acquire Two Migraine Products from Upsher-Smith; FibroGen’s Phase 3 ZEPHYRUS-1 Study of Pamrevlumab; FDA Orphan Drug Designation to ERAS-801 for Malignant Glioma

multiple-system-atrophy-treatment

Evolving Landscape of Multiple System Atrophy Treatment: Recent Developments and Future Directions

MedTech News for Endologix, SunMed, BD

Centinel Spine’s Prodisc C Match-the-Disc Cervical TDR System; Reflow Medical’s DEEPER OUS Trial; FDA Approval to Endologix’s Detour System; FDA Clearance to Smith+Nephew’s Shoulder Replacement System; SunMed Acquired Avanos’s Respiratory Health Business; BD’s Automate Clinical Flow Cytometry

Pharma News for Kyverna, Annovis, Astellas, FibroGen

FDA Fast Track Status to Kyverna’s KYV-101; Annovis’s Phase III Study for Buntanetap; Gilteritinib Demonstrated Benefit in AML Patients; FDA Orphan Drug Designation to DTx Pharma’s DTx-1252; FibroGen’s LELANTOS-1 Phase 3 Clinical Study Result

MedTech News for Olympus, Artelon, Masimo, Gore

Olympus’s Next Generation Electrosurgical Generator; Biocomposites Acquires Artoss GmbH; Artelon’s FlexBand, FlexPatch, and FlexBand Plus; Masimo’s Radius VSM; Gore’s GORE VIAFORT Vascular Stent; Synergy Spine Solutions’s 1-Level IDE Trial

Pharma News for Pfizer, Daiichi Sankyo, Kyverna, Servier

Daiichi Sankyo’s Intravenous Iron Replacement Therapy; ANeuroTech’s Adjunctive Anti-depression Drug, ANT-01; Kyverna Therapeutics’s KYV-101 in Lupus Nephritis; Servier Presents Data from Phase 3 INDIGO Trial of Vorasidenib; FDA Approves Pfizer’s ABRYSVO

MedTech News for Cepheid, Anika, EMVision

THINK Surgical’s TMINI Miniature Robotic System; Cepheid’s Xpert NPM1 Mutation Test; Anika’s Hyalofast® US Pivotal Phase III Study; EMVision’s Portable Brain Scanner Trial; HeartBeam and Samsung’s Strategic Alliance Agreement; Eosolutions’s Dr. Banner Balloon Guide Catheter

parkinsons-disease-psychosis-treatment

What Lies Ahead For Parkinson’s Disease Psychosis Treatment Market?

MedTech News for Abbott, Regen Lab, Beckman Coulter, Shockwave Medical, Providence Medical Technology, ONWARD Medical N.V

FDA Approves Abbott’s Spinal Cord Stimulation Systems; Regen Lab Received CE Certification for Three PRP Solutions; Beckman Coulter Launched New Immunoassay Analyser; Shockwave Medical’s Coronary IVL Catheter; Providence Completed Enrollment in the FUSE Clinical Study; Onward Completed First-In-Human Use of Movement-Restoring Lead

Norlase, HAPPE Spine, Soterix Medical, Akura Medical, Intelivation Technologies, Signifier Medical Technologies

Norlase’s ECHO™ Green Pattern Laser; HAPPE Spine’sINTEGRATE-C™ Interbody Fusion System; Soterix Medical’s Parcel-Guided rTMS Depression Trial; Akura Medical’s High-Performance Mechanical Thrombectomy Platform; Intelivation Technologies’s Golden Isles™ Minimally Invasive Pedicle Screw System; Signifier Medical Technologies Announced Partnership with Sunrise

Pharma News and Updates for GSK, Gilead, ProMIS, Nucleix, PharmaTher, Vedanta Biosciences

FDA Approves GSK’s Arexvy for RSV; CHMP’s Opinion on Gilead’s Hepcludex® for HDV; FDA Clearance to ProMIS’s IND Application for PMN310; FDA Grants 501K Clearance to Bladder EpiCheck; PharmaTher Submits Fast Track Application for Ketarx to US FDA; Fast Track Designation to Vedanta Biosciences’ VE303

pharma-news-for-bms-teva-biogen-atsena-kiromic

FDA Grants Priority Review to BMS’ Luspatercept; Teva and MedinCell’s Risperidone FDA Approval; Biogens’s QALSODY FDA Accelerated Approval; FDA IND Authorization to Kiromic’s Deltacel; Atsena’s ATSN-201 FDA IND Clearance

MedTech News for Bausch + Lomb, Heidelberg Engineering, Oxford Nanopore, bioMérieux, Senseonics, Boomerang Medical, RapidAI, Neuspera Medical

Bausch + Lomb and Heidelberg Engineering Introduced SeeLuma; Oxford Nanopore and bioMérieux Signs Partnership Agreement; Boomerang Medical’s Bioelectronic Device for Inflammatory Bowel Disease; Senseonics’s ENHANCE Clinical Trial Updates; RapidAI’s Non-Contrast CT Imaging Product; FDA Clearance for Neuspera Medical’s Peripheral Nerve Stimulation System

Pharma News and Updates for RegeneRx, Aldeyra, Oncolyze, Soligenix, Aviceda

RegeneRx’s Phase 3 Neurotrophic Keratitis Clinical Trial of RGN-259; Aldeyra’s Phase 3 INVIGORATE-2 Clinical Trial Update; FDA Orphan Drug Designation to Oncolyze’s OM-301 for Multiple Myeloma; Soligenix Provides Regulatory Update on HyBryte; FDA Fast Track Designation to SAB Biotherapeutics’s SAB-176 Influenza Immunotherapy; Aviceda IND Application for AVD-104

Pharma News and Updates for Cingulate, Merck, Transcenta, Ipsen, Nuance

Ipsen’s Cabometyx Rejected by NICE; Vertex and CRISPR Therapeutics’s Submit BLA to the FDA for exa-cel; Orphan Drug Designation to Osemitamab for Pancreatic Cancer; FDA Clears Keytruda/Padcev for Bladder and Urothelial Cancer; Cingulate Completes Trial of CTx-1301 for ADHD; Nuance Pharma Announces Dosing of First Patient in ENHANCE Trial

MedTech News and Updates for Mindray, Getinge, Gore, CoreLink

Mindray’s TE Air Handheld Ultrasound System; Getinge’s iCast™ Covered Stent System; Clinical Trial Update for the FLASH Proton Therapy for Cancers in the Bones; Gore’s Gore® Viafort Vascular Stent IVC Study; CoreLink’s Siber® Ti—3D Printed SI Joint Fusion System; USound and Partners’s Next-Generation Over-the-Counter Hearing Aids

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