In Editorial, The New England Journal of Medicine Calls Science Corporation’s PRIMA Implant “The First Treatment to Restore Vision” In Patients Suffering From Advanced Geographic Atrophy Due to Age-related Macular Degeneration

ALAMEDA, Calif.–(BUSINESS WIRE)–An editorial published today in The New England Journal of Medicine (NEJM) writes that Science Corporation’s PRIMA implant is the first treatment in clinical trials to successfully restore functional vision to certain patients suffering from geographic atrophy (GA) due to age-related macular degeneration (AMD), a leading cause of blindness affecting more than 5 … [Read more…]

Understanding Medical Device Regulatory Pathways – 510(k), PMA & Exemptions Webinar – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Understanding Medical Device Regulatory Pathways – 510(k), PMA & Exemptions (January 15, 2026)” training has been added to ResearchAndMarkets.com’s offering. This expert-led 3-hour webinar provides a comprehensive introduction to the key regulatory pathways for medical device submissions in the US market. The regulation and control of new or substantially changed medical devices for … [Read more…]

VizMark Secures FDA 510k Clearance for VM1 Visual Tumor Marker, Advancing Precision in Breast Cancer Imaging

PLYMOUTH, Minn.–(BUSINESS WIRE)–VizMark has received U.S. Food and Drug Administration FDA 510k clearance for VM1, a non-metal visual tumor marker designed to provide artifact-free visibility across all major breast imaging modalities, including MRI, mammography, X-ray, CT, and ultrasound. VM1 was developed to address long-standing limitations of metallic markers, which can create artifacts on MRI and … [Read more…]

Auditing and Qualifying Suppliers and Vendors: An Effective Risk-based Approach Training Course (Mar 3rd – Mar 5th, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Auditing and Qualifying Suppliers and Vendors: An Effective Risk-based Approach (Mar 3rd – Mar 5th, 2026)” training has been added to ResearchAndMarkets.com’s offering. Supplier or vendor qualification is a crucial component in compliance to 21 CFR 111. The FDA requires that manufacturers of dietary supplements, Pharmaceuticals, Biotech and Medical Device must “qualify” each … [Read more…]

Caldera Therapeutics Launches with $112.5 Million and Announces First Subjects Dosed in Phase 1 Trial of First-In-Class Bispecific Antibody CLD-423 for Inflammatory Bowel Disease

Initial $75M Series A investment from founding investors Atlas Venture, LAV and venBio in April 2025, recently augmented by $37.5M Series A-1 funding led by Omega Funds, with participation from additional new investors Wellington Management and Janus Henderson Investors Proceeds will fund ongoing clinical development of CLD-423, a bispecific antibody targeting the clinically validated IL-23p19 … [Read more…]

Almirall Presents R&D Pipeline Advances Supported by Sustained Growth and Leadership in Medical Dermatology at J.P. Morgan Healthcare Conference

Pipeline advances in 2026 span a range of dermatology disease areas, including atopic dermatitis, hidradenitis suppurativa, and alopecia areata, with 3 ongoing PoC/Phase II clinical studies* and 3 additional studies to be initiated in 2026. Almirall’s sustained trajectory of growth and profitability enables the company to reach more patients and supports a growth outlook of … [Read more…]

TOXINS 2026: Clinical Updates on Galderma’s Leading Neuromodulator Portfolio Further Reinforce Its Leadership in Injectable Aesthetics

Galderma will present data on Relfydess® (RelabotulinumtoxinA) – the first and only ready-to-use liquid neuromodulator designed with PEARL™ Technology – which further demonstrate its rapid onset and efficacy through 6 months in both moderate-to-severe frown lines (glabellar lines) and crow’s feet (lateral canthal lines)1-3 Dysport® (AbobotulinumtoxinA) data demonstrating high levels of patient and practitioner satisfaction … [Read more…]

Zayed Sustainability Prize Honours Global Pioneers Advancing Progress

US$5.9M awarded to 11 organisations and high schools from the UAE, Brazil, Canada, Nepal, Switzerland, Uganda and across six sustainability categories From AI-enabled diagnostics to Cooling-as-a-Service, this year’s winners deliver locally adapted innovations that empower millions In 18 years, the Prize has scaled solutions reaching more than 411 million people globally ABU DHABI, United Arab … [Read more…]

Align Technology Sponsors 30 Invisalign® Treatments Through Smiles4Canada Program to Provide Orthodontic Care to Children and Teens

Sponsorship reflects commitment to increasing access to care for orthodontic treatment especially for children, and Align’s support of the Canadian orthodontic profession TEMPE, Ariz.–(BUSINESS WIRE)–Align Technology, Inc. (NASDAQ: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign® System of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital … [Read more…]

Zonsen PepLib Biotech and Novartis Sign Worldwide License Agreement regarding Radioligand Therapy Asset

ZHUZHOU, China & BOSTON–(BUSINESS WIRE)–Zonsen PepLib Biotech Inc. (“PepLib”) today announced that it has entered into a worldwide license agreement with Novartis for an undisclosed peptide-based asset in the field of radioligand therapies (RLTs). Under the agreement, Novartis has obtained an exclusive worldwide license and will be responsible for the development and commercialization activities for … [Read more…]