Notizia - Recent Pharma, Healthcare and Biotech Happenings

MedTech News for Savara, CRVx, Gore, Masimo

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Savara Introduced aPAP ClearPathTM; RaySearch Released RayStation 2024A; FDA Approved Expanded Label for CVRx Neuromod Tech; FDA Clearance to Masimo’s Baby Monitoring System; Kansas City Proton Institute’s Advanced MEVION S250i Proton Therapy System; Gore’s Arise II Pivotal Study of the Gore® Ascending Stent Graft

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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

Pharma News and Updates for Sarepta, Astellas, SiSaf, ImmPACT Bio, Otsuka, CytoAgents, Lundbeck

Sarepta Therapeutics’s SRP-9001 Gene Therapy; FDA Approves Astellas’ VEOZAH; FDA Orphan Drug Designation and Rare Pediatric Disease Designation to SiSaf’s siRNA Therapy SIS-101-ADO; FDA Grants Fast Track Designation to IMPT-314; FDA Approves First Drug for Agitation in People With Alzheimer’s Disease; FDA Accepted the CytoAgents’ IND Application for CTO1681

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

MedTech News and Updates for Apyx, Medtronic, Vivasure, SunMed, Eitan Medical, Concept Medical, Vyaire Medical

Apyx Medical Received FDA 510(k) Clearance for the Use of Renuvion; Medtronic’s Next-generation Micra Leadless Pacing Systems; Concept Medical’s MagicTouch Sirolimus Coated Balloon Catheter; Vivasure’s Pivotal PATCH Study; SunMed Acquires the Vyaire’s Respiratory & Anesthesia Consumables Business; Eitan Medical’s Connected Avoset™ Infusion Platform

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 and Update GE HealthCare, Medtronic, Nevro, Syntr Health Technologies, Devyser + Thermo Fisher Scientific, Smith+Nephew

GE HealthCare’s CARESCAPE Canvas Patient Monitoring Platform; Medtronic’s MiniMed™ 780G System; Nevro Enroll’s First Patient in PDN Sensory Study; Syntr Health Presents Data from Facial Fat Transfer Clinical Study; Devyser-Thermo Fisher Scientific Signs Agreement; Smith+Nephew Introduced Digital Tensioning Device

Pharma News for XORTX, Roche, Lantheus, Janssen, Daiichi Sankyo, bluebird bio, and POINT Biopharma Global

Janssen’s AKEEGA Approval; FDA Approves Roche’s Polivy Combo for Frontline B-cell Lymphoma; Daiichi Sankyo’s Quizartinib for Adults With FLT3-ITD-Positive AML; bluebird bio BLA for lovo-cel for Patients with Sickle Cell Disease; Fast Track Designation for Lu-PNT2002 for mCRPC Treatment; FDA Orphan Drug Designation to XORTX’s Oxypurinol

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

MedTech News for BD, Icentia, Bone Biologics, Compal Electronics, Avation Medical, Cardiovascular Systems

BD’s Advanced Ultrasound Technology for IV Insertions; Compal Electronics Launched New RFA System AblatePal; Icentia Received Clearance for CardioSTAT; Avation Medical Announced Clearance for the Vivally® System; Cardiovascular Systems’s ECLIPSE Clinical Trial; Bone Biologics Received Approval to for Pilot Trial with NB1 in Spinal Fusion Patients

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 for Laborie, Cadwell, Endotronix, Sonex Health, Leica Biosystems, Abbott

Laborie Launched alpHaONE; Cadwell Launched Arc Voyager; Endotronix’s PROACTIVE-HF Pivotal Trial; Sonex Health’s Office-based Carpal Tunnel Release System with Ultrasound Guidance; Leica Biosystems’s BOND MMR Antibody Panel; Abbott Received FDA Approval for Epic™ Max Tissue Valve

Pharma News and updates for HUTCHMED, Cytokinetics, Astellas, Seagen, Nanoscope Therapeutics, Cabaletta Bio, Decibel Therapeutics

HUTCHMED’s NDA Submission to FDA for Fruquintinib; Cytokinetics to Discontinue ALS Drug Candidate Following Phase III Trial Failure; Enfortumab Vedotin + Pembrolizumab Approved for Urothelial Carcinoma; Nanoscope Gene Therapy Clears Phase II Retinitis Pigmentosa Trial; FDA Clearance to Cabaletta Bio’s IND Application for CABA-201 for SLE Treatment; European Orphan Drug Designation to Gene Therapy Candidate DB-OTO

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

Pharma News and Updates for Novartis, Pharming, Cyclerion, Iovance, BPGbio

Novartis Announces the Positive Results of Phase III NATALEE Trial Evaluating Kisqali; FDA Approves Pharming’s Joenja for APDS; FDA Orphan Drug Designation to Cyclerion’s Zagociguat; Iovance Completes BLA Submission for Lifileucel in Advanced Melanoma; BPGbio Announces Partnership with debra of America

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