Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

FDA Approves Boehringer’s JASCAYD as First New IPF Therapy in Over a Decade; Denali Therapeutics’ Tividenofusp Alfa BLA Review for Hunter Syndrome Extended by FDA; Bicara’s Ficerafusp Alfa Earns FDA Breakthrough Tag for 1L HPV-Negative Head & Neck Cancer; BeOne Medicines’ Sonrotoclax Granted FDA Breakthrough Designation for Cancer Treatment; FDA Clears LIBTAYO for Adjuvant Use in Cutaneous Squamous Cell Carcinoma

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Vektor Medical Receives CE Mark for vMap; Tosoh’s GR01 HbA1c Analyzer Gains FDA 510(k) Clearance; Zimmer Biomet Acquires Monogram Technologies; Olympus Partners with W. L. Gore & Associates to Distribute GORE® VIABIL® Biliary Stent Globally; Medtronic Launches U.S. IDE Study on Hugo™ Robotic Surgery System for Gynecology; Envoy Medical Secures FDA Clearance to Advance Pivotal Trial to Final Stage Following Promising Three-Month Results

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Aminex Therapeutics Secures FDA Orphan Drug Designation for AMXT 1501 + DFMO in Neuroblastoma; Eccogene Gets FDA Nod to Begin Phase IIa MOSAIC Trial of ECC4703 + ECC0509 in MASH; Orca Bio’s Orca-T Earns FDA Priority Review for Hematologic Malignancies; Alto Neuroscience Gains FDA Fast Track for ALTO-101 in Cognitive Impairment Linked to Schizophrenia; Taysha Gene Therapies Wins FDA Breakthrough Therapy Status for TSHA-102 in Rett Syndrome

medtech-news-for-zimmer-biomet-sky-labs-fluidai-medical

Zimmer Biomet Secures Japan PMDA Approval for First Iodine-Treated Total Hip Replacement System; FluidAI Medical’s Origin™ Earns FDA 510(k) Clearance; Sky Labs Introduces CART BP; Forward Science Collaborates with Sage Dental to Launch PerioStōm; iotaMotion Sets New Benchmark with 1,000+ Cochlear Implant Procedures Using iotaSOFT®; Relief Cardiovascular Completes First Human Implant of Pioneering Smart Valve for Heart Failure Congestion

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Regeneron’s EVKEEZA Wins FDA Approval for HoFH in Children as Young as 1 Year; Eli Lilly’s INLURIYO Approved for ER+, HER2-, ESR1-Mutated Advanced Breast Cancer; Janssen’s TREMFYA Secures FDA Nod for Pediatric Plaque Psoriasis and Psoriatic Arthritis; Kedrion Biopharma’s QIVIGY Approved for Primary Humoral Immunodeficiency in Adults; Crinetics Pharma Wins FDA Approval for First Daily Pill, PALSONIFY, for Rare Growth Disorder

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Medtronic Gains FDA Clearance for Altaviva™ Device to Simplify Treatment of Urge Urinary Incontinence; FDA Grants Breakthrough Device Status to Virtuoso’s Surgical Robot; Lunit and Agilent Strike Partnership to Integrate AI into Biomarker-Based Diagnostics; QuidelOrtho Launches QUICKVUE Influenza + SARS Test for Clinical Use; Transpara® Breast AI Chosen to Power $16M PRISM Clinical Trial in the U.S.; IceCure Showcases ProSense® at CIRSE 2025 with Strong Clinical Evidence from 4 Independent Cryoablation Studies

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Merck Wins FDA Approval for KEYTRUDA QLEX for Subcutaneous Use in Adults With Solid Tumors; Incyte Gains FDA Nod for OPZELURA Cream in Children Aged 2–11 With Atopic Dermatitis; Minovia Therapeutics Receives FDA Fast Track Designation for MNV-201 in Myelodysplastic Syndrome; MavriX Bio Secures FDA Fast Track for MVX-220 Gene Therapy in Angelman Syndrome; Biocon Biologics Gets FDA Approval for Denosumab Biosimilars BOSAYA and AUKELSO

medtech-news-for-amber-implants-rejuva-fresh-ge-healthcare

Amber Implants Wins FDA 510(k) Clearance for VCFix® Spinal System; Merit Medical’s Embosphere Microspheres Receive CE Mark for Genicular Artery Embolisation in Knee OA; Rejuva Fresh® Introduces REVIVO™ Dual Summit 1927/1550 Fractional Laser System; GE HealthCare Eyes Acquisition of icometrix to Enhance Neurology Imaging and Brain MRI Assessment Tools; Diality Reports First Patient Dosed in Moda-flx Home IDE PRESCRIBE Trial; DUBSTENT DIABETES Trial Begins Enrollment: Aiming to Optimize PCI Outcomes in Patients with Diabetes

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Lion TCR Secures Triple FDA Milestones with IND Clearance for Chronic Hepatitis B; Corstasis Therapeutics Wins FDA Approval for ENBUMYST Nasal Spray to Treat Edema in CHF, Liver, and Kidney Disease; Amneal Gains FDA Approval for Sodium Oxybate Oral Solution in Narcolepsy Patients with Cataplexy and Excessive Daytime Sleepiness; Greenwich LifeSciences’ GLSI-100 Granted FDA Fast Track Designation; Akeso’s Ligufalimab Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia

medtech-news-for-onward-medical-fraiya-medtronic

ONWARD Medical’s ARC-EX System Gains CE Mark; Microbot Medical Secures FDA 510(k) Clearance for LIBERTY® Endovascular Robotic System; Fraiya Launches Major NHS Clinical Trial Using AI for Pregnancy Ultrasounds; Medtronic Hugo™ Robotic-assisted Surgery System in Hernia Repair Met Safety and Effectiveness Endpoints; Willow Launches Willow Wave, Pioneering a New Standard in Breastfeeding; Vivalink Launches New Adhesive to Improve Wearable ECG Performance

pharma-news-for-takeda-telix-boehringer

NeuroNOS’ BA-101 Granted FDA Orphan Drug Status for Glioblastoma; Takeda’s VONVENDI Approval Expanded for Von Willebrand Disease in Adults and Children; Telix Gains FDA Nod on Resubmission Pathway for TLX101-CDx NDA; Saol Therapeutics Receives FDA CRL for SL1009 in Pyruvate Dehydrogenase Complex Deficiency; FDA Grants Breakthrough Therapy Designation to Boehringer’s HERNEXEOS for HER2-Mutant Advanced NSCLC

medtech-news-for-geneseeq-technology-medtronic-corneat-vision

Geneseeq Technology Inc.’s GENESEEQPRIME® Assay Receives FDA 510(k) Clearance; Medtronic’s MiniMed™ 780G Gains FDA Approval for Abbott Instinct Sensor Integration and Type 2 Diabetes Use; CorNeat Vision’s Artificial Cornea Restores 20/20 Vision for Shingles-Induced Blindness; Johnson & Johnson Reports Favorable Outcomes from Real-World VARIPULSE™ PFA Study at 2025 ESC Congress; SprintRay Strengthens Dental 3D Printing Portfolio with EnvisionTEC Acquisition; Olympus Unveils Latest Imaging Platform for ENT and Urology in the U.S.

pharma-news-for-eisai-travere-sanofi

FDA Approves Eisai & Biogen’s LEQEMBI IQLIK for Maintenance Treatment of Early Alzheimer’s; Travere Therapeutics Gains FDA Nod for FILSPARI REMS Update in IgA Nephropathy; Vanda Pharmaceuticals’ VGT-1849B Granted FDA Orphan Drug Status for Polycythemia Vera; Teva Launches First FDA-Approved Generic SAXENDA for Weight Loss; Sanofi’s WAYRILZ Gets FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia

medtech-news-for-esaote-medmira-moleculight

Esaote’s MyLab™ A50 and A70 Ultrasound Systems Achieve FDA 510(k) Clearance; Health Canada Approves MedMira’s Reveal® TP Rapid Test for Syphilis; MolecuLight’s Transformative Effect on Wound Care Confirmed by Large Randomized Trial; Arctx Medical’s ACC Kit Receives FDA IDE Approval and Dr. Robert Kieval Appointed CEO; Quest’s Haystack MRD Test Awarded FDA Breakthrough Device Designation for Post-Surgical Colorectal Cancer Monitoring; Sonic Healthcare USA Strengthens Oncology Diagnostics with Acquisition of Cairo Diagnostics

pharma-news-for-madrigal-valneva-protagonist

Madrigal Wins EU Approval for REZDIFFRA in MASH With Liver Fibrosis; Valneva Faces FDA License Suspension for Chikungunya Vaccine IXCHIQ; Coya Secures FDA IND Clearance for COYA 302 in ALS Treatment; Rusfertide Earns FDA Breakthrough Therapy Designation for Polycythemia Vera; Crinetics Gains FDA Orphan Drug Status for Atumelnant in Congenital Adrenal Hyperplasia

medtech-news-for-nerveblox-labcorp-calidar

FDA Grants 510(k) Clearance to Nerveblox AI; Labcorp Introduces the First FDA-Cleared Alzheimer’s Blood Test; Calidar Introduces First-of-its-Kind 4D Mammography System; ONWARD Medical to Initiate Empower BP Pivotal Study Following FDA IDE Approval; Tenon® Medical Launches Catamaran® SE SI Joint Fusion System Nationwide; Rivanna Secures $800,000 Virginia Catalyst Grant Plus Matching Funds to Advance AI-Driven Ultrasound Innovation

pharma-news-for-precigen-regenxbio-tonix

Precigen’s PAPZIMEOS Wins Full FDA Approval for Recurrent Respiratory Papillomatosis; Tonix’s Tonmya Becomes First FDA-Approved Fibromyalgia Treatment in Over 15 Years; FDA Extends BLA Review for REGENXBIO’s RGX-121 in MPS II Patients; SystImmune’s Izalontamab Brengitecan (EGFRxHER3 ADC) Gets FDA Breakthrough Designation for EGFR-Mutated NSCLC; Soligenix Granted FDA Orphan Drug Status to SGX945 for Behçet’s Disease Therapy Following Phase II Success

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