Galderma’s Nemluvio® Approved in UK & Switzerland for Skin Conditions Galderma, a global leader in dermatology, has announced that its innovative monoclonal antibody treatment, Nemluvio® (nemolizumab), has been granted marketing authorization by both the United Kingdom’s Medicines and Healthcare products…
FDA Grants Breakthrough Status to Innate Pharma’s Lacutamab for Sézary Syndrome Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) announced today that the U.S. FDA has granted Breakthrough Therapy Designation (BTD) to lacutamab, an anti-KIR3DL2 cytotoxicity-inducing…
U.S. FDA Fully Approves Deciphera’s ROMVIMZA™ for TGCT Treatment Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) has announced that the U.S. Food and Drug Administration (FDA) has granted full approval for ROMVIMZA™ (vimseltinib), a kinase inhibitor,…
OS Therapies Initiates Commercial-Ready Manufacturing of OST-HER2 to Support Anticipated Biologics Licensing Application (BLA) Filing OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company dedicated to advancing immunotherapies and targeted drug conjugates for the treatment of cancer, has announced a…
Junevity Secures $10M to Advance Cell Reset Therapies for Longevity Junevity Secures $10M in Seed Funding to Develop Cell Reset Therapies Targeting Age-Related Diseases Junevity, a forward-thinking biotechnology company focused on addressing the root causes of aging, has raised $10…
Opna Bio Secures Orphan Drug Designation for OPN-6602 in Multiple Myeloma Opna Bio, a clinical-stage biopharmaceutical company dedicated to the discovery and development of innovative oncology therapeutics, has announced that the U.S. Food and Drug Administration (FDA) has granted orphan…
Kidney Transplant Eledon Pharmaceuticals Advances Xenotransplantation with Tegoprubart Kidney Transplant Eledon Pharmaceuticals has announced that its investigational anti-CD40L antibody, tegoprubart, was a crucial component of the immunosuppression regimen used in a historic kidney xenotransplantation procedure. On January 25, 2025, a…
Onc.AI Secures FDA Breakthrough Device Designation for AI-Powered CT Response Model Onc.AI, FDA a pioneering digital health company specializing in AI-driven oncology clinical management solutions, has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting Breakthrough…
Swing Therapeutics’ Stanza Receives Positive Coverage Decision from Highmark Health for Fibromyalgia Treatment In a major breakthrough for the treatment of fibromyalgia, Swing Therapeutics has announced that Stanza, its innovative digital therapeutic, has received a positive coverage decision from Highmark…
DNAnexus Expands Relationship with Veeva to Advance Global Regulatory Collaboration DNAnexus, a global leader in regulatory cloud services, has announced the expansion of its collaboration with Veeva Systems, a prominent provider of cloud-based software for the life sciences industry. This…
Bayer has officially submitted a marketing authorization application to the European Medicines Agency (EMA), seeking approval for the use of finerenone in adult patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of 40% or greater. This…
Median Technologies has announced a significant milestone in its mission to revolutionize lung cancer screening. The company’s proprietary artificial intelligence (AI) and machine learning (ML)-based software, eyonis™ Lung Cancer Screening (LCS), has successfully met the primary endpoint in the RELIVE…