Osivax Secures Key Funding to Advance Next-Gen Influenza Vaccines Osivax, a biopharmaceutical company dedicated to developing next-generation vaccines that offer broad-spectrum protection against highly mutating respiratory viruses, has successfully secured strategic funding to accelerate the development of its influenza vaccine…
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…
