FDA Accepts sBLA for Genentech’s Gazyva in Lupus Nephritis Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA)…
Shorla Oncology Expands U.S. Presence with New Sales & Market Access Teams Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, has officially launched a dedicated sales force and market access teams to support the commercial rollout of IMKELDI, the first…
Medable Secures CNIL Approval, Paving the Way for Digital Clinical Trials in the EU Medable Inc., a global leader in clinical development technology, has reached a significant regulatory milestone with the approval of its eConsent and electronic Clinical Outcome Assessment…
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,…