Samsung Bioepis plans to secure 20 biosimilars in its products and pipeline by 2030 The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab, in addition to pembrolizumab currently in Phase 1 and 3 clinical studies Having secured investigational new drug application (IND) clearance from the U.S. Food and Drug Administration (FDA), … [Read more…]

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…]

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…]

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…]

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…]

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…]

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…]

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…]

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…]

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…]