U.S. FDA grants approval to complete enrollment in EndoQuest’s ongoing PARADIGM Trial following the clinical study’s favorable interim safety review HOUSTON–(BUSINESS WIRE)–EndoQuest Robotics, Inc., a pioneering leader in endoluminal robotic surgical technology, today announced that the U.S. Food and Drug Administration (FDA) has approved initiation of the next and final stage of its pivotal multicenter … [Read more…]
LEXINGTON, Mass.–(BUSINESS WIRE)–$AGEN #BAL—Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced the closing of its previously disclosed strategic collaboration with Zydus Lifesciences Ltd. The agreement is designed to accelerate global development and potential commercialization of Agenus’ botensilimab and balstilimab (BOT+BAL) immunotherapy combination program. The collaboration provides Agenus with strategic capital and committed, … [Read more…]
Medscape reporting and survey data show why doctors are coming to the UK, what it takes to work in the NHS and what’s now pushing many to look elsewhere. LONDON–(BUSINESS WIRE)–Doctors trained overseas make up a substantial and growing share of the UK medical workforce, with new data underscoring the NHS’s deep reliance on international … [Read more…]
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…]
