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.
Pfizer, GSK Gain ACIP Recommendations for RSV and Meningococcal Vaccines
April 18th 2025The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to expand access to Pfizer’s respiratory syncytial virus vaccine Abrysvo for high-risk adults in their 50s and voted in favor of GSK’s meningococcal vaccine, Penmenvy, for streamlined adolescent protection.
Is Artificial Intelligence a ‘Product’? Products Liability Implications for AI-Based Products
April 10th 2025As the physical products we use evolve to become increasingly complex, traditional products liability frameworks may not always fit to provide remedies for harm that can result from using novel product types.
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.