argenx SE a global immunology company focused on developing innovative therapies for patients with severe autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental Biologics License Application (sBLA) for VYVGART® (intravenous…
FDA Accepts Merck’s New Drug Application for Pimicotinib in Tenosynovial Giant Cell Tumor Merck, a global leader in science and technology, has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for pimicotinib,…
Longer-Term OrigAMI-1 Results Highlight Durable Activity of Amivantamab-Based Regimens in Metastatic Colorectal Cancer Johnson & Johnson has announced encouraging longer-term follow-up results from the Phase 1b/2 OrigAMI-1 clinical study evaluating amivantamab-vmjw, an investigational bispecific antibody targeting both epidermal growth factor…
SAGA Diagnostics Highlights Clinical Validity of Pathlight™ MRD in TNBC During SABCS Presentations SAGA Diagnostics Highlights Clinical Validity of Pathlight™ MRD in TNBC During SABCS Presentations. SAGA Diagnostics®, a leader in blood-based cancer detection and precision oncology, continued to advance…
Onchilles Pharma Publishes Landmark ELANE Pathway Study and Advances N17350 Toward Clinical Trials With $25 Million Series A1 Financing and New Clinical Advisor Peer-reviewed study in Cell Reports Medicine validates ELANE pathway as a cancer-selective, immune-activating mechanism and supports advancement…
City of Hope Appoints Dr. Christine M. Lovly to Lead National Thoracic Oncology Program City of Hope has announced the appointment of physician-scientist Christine M. Lovly, M.D., Ph.D., F.A.S.C.O., as the head of its new National Thoracic Oncology Program, effective…
Phase III ALLEGORY trial achieved its primary and all key secondary endpoints with Gazyva, an anti-CD20 monoclonal antibody engineered to enhance B cell depletion. – Gazyva shows potential to become a transformative new standard of care for up to 3.4…
Enigma Biomedical USA Announces FDA Acceptance of New Drug Application for Tau PET Radiodiagnostic MK-6240 in Alzheimer’s Diseas Biomedical USA (EB USA) today announced that the U.S. Food and Drug Administration (FDA) has formally accepted the New Drug Application (NDA)…
Ferring Showcases New Real-World Evidence on ADSTILADRIN® at the 101st Western Section AUA Annual Meeting Napa, CA — October 29, 2025 — Ferring Pharmaceuticals today announced that three abstracts highlighting new real-world data for ADSTILADRIN® (nadofaragene firadenovec-vncg) will be presented…
Ferrer Completes Patient Enrollment for the PROSPER Phase II Clinical Trial in Progressive Supranuclear Palsy Ahead of Schedule Barcelona, Spain — [October 2025] — Ferrer, the international pharmaceutical company headquartered in Spain, today announced the successful completion of patient recruitment…