Sanofi, AstraZeneca Launch Program to Mitigate Future RSV Vaccine Shortages
February 2nd 2024New reservation program for Beyfortus (nirsevimab-alip) seeks to improve access to the monoclonal antibody that is FDA-approved to protect against respiratory syncytial virus-associated lower respiratory tract disease.
In New Year, Resolve to Solve Drug Supply Chain Security Act Compliance
January 31st 2024Under the DSCSA law, wholesale distributors, re-packagers, dispensers, and other third-party logistics providers must implement interoperable and electronic tracing of prescription products at the package level.
Johnson & Johnson Files sBLA for Darzalex Faspro Combination in Multiple Myeloma
January 31st 2024FDA to evaluate Darzalex Faspro with bortezomib, lenalidomide, and dexamethasone for induction and consolidation treatment and with lenalidomide for the maintenance treatment of adults newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant.
Approval Sought for Keytruda/Padcev Combination for First-Line Treatment of Urothelial Cancer
January 31st 2024FDA to evaluate Padcev (enfortumab vedotin) with Merck’s Keytruda (pembrolizumab) for the first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer.
Gammagard Liquid Gets FDA Approval for Chronic Inflammatory Demyelinating Polyneuropathy
January 30th 2024Gammagard Liquid is now FDA-approved to treat neuromuscular disability and impairment in adults with CIDP; as a replacement treatment for primary immunodeficiency in patients aged 2 years and older; and as a maintenance treatment to improve muscle strength and disability in adults with multifocal motor neuropathy.