Celltrion Secures EC Approval for Avtozma® (CT-P47), a Biosimilar to RoActemra® Celltrion has announced that the European Commission (EC) has granted marketing authorization for Avtozma® (CT-P47), a biosimilar referencing RoActemra® (tocilizumab). This approval marks a significant milestone for Celltrion, reinforcing…
CHMP Recommends EU Approval of ENHERTU® for HER2 Low/Ultralow Metastatic Breast Cancer Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have achieved a significant milestone with the recommendation for approval of their drug ENHERTU® (trastuzumab deruxtecan) in the European Union…
FDA Accepts sBLA for Opdivo® + Yervoy® in MSI-High/dMMR Cancers U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Supplemental Biologics License Application for Opdivo® Plus Yervoy® for Patients with Unresectable or Metastatic Microsatellite Instability-High or Mismatch Repair Deficient Colorectal…
Sensorion Gets Positive Board Recommendation for SENS-501 Trial Sensorion a pioneering clinical-stage biotechnology company specializing in the development of innovative therapies for hearing loss disorders, has announced a significant milestone in its Audiogene clinical trial. The company reported that the…
Eikon Therapeutics Showcases Oblique Line Scan Tech in Nature Method Eikon Therapeutics, Inc., a clinical-stage biotechnology company that integrates advanced engineering with cutting-edge molecular and cell biology to accelerate drug discovery and development, has announced a new publication in Nature…
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…