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Ophthalmology

MedTech News for Integra, B. Braun, Medtronic, Perfuze

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Integra to Buy J&J’s Acclarent; B. Braun Launches the CARESITE Micro Luer Access Devic; FDA Approves Medtronic’s Novel PulseSelect Pulsed Field Ablation System; FDA Clearances to Perfuze’s Novel Neurovascular Aspiration and Access Catheters for Stroke Treatment; ShiraTronics Successfully Implants First Migraine System; Sight Sciences Announced the Six-Month Results For Heat Therapy Device

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Pharma News for GSK, Roche, Avita, Ipsen

FDA Extended the Review Period for Momelotinib; FDA Approves Roche’s Columvi; Avita Medical Obtains FDA Approval of RECELL; FDA Approves Odevixibat for ALGS; TME Pharma Receives IND Approval for NOX-A12; Aldeyra’s Phase 3 INVIGORATE‑2 Trial of Reproxalap

Pharma News for AbbVie, Oculis, AstraZeneca, Krystal Biotech, Alligator Biosciences

FDA Approves RINVOQ for Crohn’s Disease; FDA Approves Krystal Biotech’s Gene Therapy Vyjuvek; FDA Approves EPKINLY to Treat R/R DLBCL; FDA Orphan Drug Designation to Mitazalimab; Phase 3 Trial Result of OCS-01 Eye Drops; TAGRISSO® + Chemotherapy for the EGFR-mutated Advanced Lung Cancer

Graves’ Ophthalmopathy Therapeutics Assessment

Graves’ Ophthalmopathy Treatment Market: A Billion-Dollar Opportunity For Pharma Companies

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

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 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 Update for Sight Sciences, HeartBeam, LIVMOR, Occlutech, PADM Medical, Kardium, LivaNova

Sight Sciences’s Ergo-Series of the OMNI® Surgical System; HeartBeam to Acquire LIVMOR’s Assets; Occlutech Atrial Flow Regulator (FROST-HF) Study Updates; US FDA 510(k) Clearance for PADM Medical’s PRECISION ECO; Kardium ‘s Pulsed-Field Ablation Study; US FDA 510(k) Clearance for LivaNova’s Essenz Heart-Lung Machine

Pharma News and Updates for Actinium, Apellis, Chiesi, IVERIC, Travere, Takeda

Actinium Announces Phase III SIERRA Trial Results; FDA Approves Apellis’s Geographic Atrophy Drug; FDA Gives Green Light to Chiesi’s Lamzede; FDA Accepts NDA and Grants Priority Review for Avacincaptad Pegol; FDA Approves Travere’s Kidney Disorder Drug; Takeda Presents Phase 3 GRAPHITE Study Results

Pharma News and Updates for Leo Pharma, GSK, Roche, Aldeyra, IASO Bio

Leo Pharma’s Hand Eczema Clinical Trial Updates; GSK’s PD-1 inhibitor Jemperli Approval; Roche Announces Phase III Result of Vabysmo; FDA Accepts NDA for Aldeyra’s reproxalap; RMAT and Fast Track Designations to IASO Bio’s CT103A; Orphan Drug Designation to Jubilant Therapeutics’s JBI-778

Pharma News Updates for Merck, Sanofi, GSK, Hinova, Endogena, Amylyx

Merck’s Keytruda Wins Another FDA Approval; Sanofi Pauses Trial of Myasthenia Gravis Drug, tolebrutinib; FDA Approves GlaxoSmithKline’s Jesduvroq; FDA IND Application Clearance for Hinova’s HP518; FDA Fast Track Designation to Endogena’s EA-2353; Amylyx Updates on Global Phase 3 PHOENIX Trial

Latest MedTech News and Updates for Tandem, NeuroMetrix, Cytovale, icotec ag

Tandem Acquires AMF Medical; NeuroMetrix Launched DPNCheck 2.0 Device; FDA Approves Cytovale’s IntelliSep Sepsis Test; FDA Clearance for the Ø 4.5mm VADER Pedicle Screws; Pie Medical Imaging’s vFFR FASTIII Trial; Hip Innovation Technology Announced Initiation Investigational Device Exemption Study

MedTech News for Cardiovascular Systems, Koneksa, Medcura, Abbott, Enovis, Bausch + Lomb, AcuFocus

First Patient Enrolled in Kaizen Clinical Study in Japan; Koneksa’s At-Home Mobile Spirometry Clinical Trial; Medcura’s LifeGel™ Absorbable Surgical Hemostat; FDA Clearance to Abbott’s NAVITOR; Enovis’s DynaClip Delta™ and DynaClip Quattro™ bone staples; Bausch + Lomb Acquired AcuFocus

acute-ocular-pain-treatment-landscape

New Technologies Conquering Drug Delivery Obstacles in Acute Ocular Pain Treatment Landscape

MedTech News and Updates for Vivos, Arthrex, Chindex, Glaukos, Zimmer Biomet

Vivos Therapeutics ‘s DNA Oral Appliance for the Treatment of OSA; Arthrex’s TightRope Implant for Pediatric ACL Surgery; Chindex Medical Acquired 10 ViewRay MRIdian Systems; Zimmer Biomet to Acquire Embody; GE HealthCare to buy IMACTIS; Glaukos Announced the iDose TR Exchange Trial

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