FDA Grants Fast Track Designation to Cancer Vaccine for Malignant Pleural Mesothelioma
February 5th 2024UV1 is an off-the-shelf vaccine that has demonstrated a survival benefit in combination with ipilimumab (Yervoy) and nivolumab (Opdivo) in patients with unresectable malignant pleural mesothelioma.
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.