May 20th 2025
Previously granted Emergency Use Authorization, Nuvaxovid is now available for individuals over 12 years of age.
FDA Issues Refusal to File for ImmunityBio’s sBLA for Anktiva in BCG-Unresponsive NMIBC
May 6th 2025The Refusal to File letter comes despite the FDA’s prior encouragement to submit a supplemental biologics license application for Anktiva in patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary disease.
FDA Approves AbbVie’s Rinvoq as First Oral JAK Inhibitor for Giant Cell Arteritis
April 30th 2025AbbVie secures FDA approval for Rinvoq as the first oral Janus kinase inhibitor indicated for giant cell arteritis, expanding its immunology portfolio and signaling strategic growth opportunities in underserved autoimmune markets.
FDA Grants Priority Review to Regeneron’s Eylea for Macular Edema Following Retinal Vein Occlusion
April 18th 2025Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks achieved non-inferior visual acuity outcomes compared to Eylea in patients with macular edema following retinal vein occlusion.
FDA Approves Opdivo Plus Yervoy Regimen for MSI-H/dMMR Colorectal Cancer
April 9th 2025Approval of the Opdivo plus Yervoy combination regimen was based on results from the Phase III CheckMate-8HW trial, which was the largest immunotherapy study in patients with previously untreated, unresectable, or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
FDA Approves Celltrion’s Xolair Biosimilar Omlyclo for Multiple Indications
March 10th 2025Omlyclo, a biosimilar to Xolair, is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E-mediated food allergies, and chronic spontaneous urticaria.
FDA Approves BeiGene’s Tevimbra for Unresectable or Metastatic Esophageal Squamous Cell Carcinoma
March 4th 2025New indication for Tevimbra in combination with platinum-containing chemotherapy as a first-line treatment addresses an unmet need for adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.
FDA Approves Celltrion’s Biosimilars Stoboclo and Osenvelt
March 4th 2025Stoboclo, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Osenvelt, a biosimilar to Xgeva, is indicated for preventing skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors.