Pharma Data Integrity Auditor Masterclass Training Course: Department-Level Audit Strategies, Critical Findings, and Regulatory Expectations (Online Event: Apr 22nd – Apr 23rd, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Data Integrity Auditor Masterclass Training Course (Apr 22nd – Apr 23rd, 2026)” training has been added to ResearchAndMarkets.com’s offering. Data integrity has received more attention than ever before in the last decade and has become the most critical audit topic for health authorities. Although data integrity has started to gain importance in recent … [Read more…]

FillPoint Health and US Heart & Vascular Partner to Expand Access to Innovative Therapies Across Complex Cardiovascular Disease Areas

DUBLIN, Ohio–(BUSINESS WIRE)–FillPoint Health, a URAC- and ACHC-accredited specialty pharmacy and management services organization (MSO) and a Lyceum Company, has announced the continued expansion of its strategic partnership with US Heart & Vascular (USHV) to advance patient access to innovative therapies across complex and underserved cardiovascular disease categories. This collaboration reflects a shared commitment to … [Read more…]

EndoQuest Receives FDA Approval to Initiate Final Stage of PARADIGM Trial

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…]

Agenus Announces Closing of $141M Strategic Collaboration with Zydus Lifesciences to Advance BOT+BAL and Strengthen U.S. Manufacturing Readiness

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…]

Overseas Doctors Power the NHS, But Uncertainty Grows

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 Epis Holdings Delivers Business Updates at the 44th J.P. Morgan Healthcare Conference

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…]

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…]