May 2nd 2024
Study explores how the Inflation Reduction Act’s Drug Price Negotiation Program and its maximum fair prices impact incentives for investments in post-approval activity.
Balversa Gets Full FDA Approval for Locally Advanced, Metastatic Urothelial Carcinoma
January 19th 2024Today's approval amends the accelerated approval granted by the FDA in April 2019 to Balversa (erdafitinib) for patients with metastatic urothelial carcinoma with susceptible FGFR2 or FGFR3 alterations following prior treatment with platinum-containing chemotherapy.
Astellas Pharma Issued Complete Response Letter for Zolbetuximab for GEJ Adenocarcinoma
January 9th 2024Astellas said it will work closely with the FDA and a third-party manufacturer to develop a timeline that will quickly resolve feedback from the complete response letter to a Biologics License Application for zolbetuximab.
sBLA for Tivdak Granted FDA Priority Review for Recurrent, Metastatic Cervical Cancer
January 9th 2024Tivdak (tisotumab vedotin-tftv), an antibody drug conjugate, was granted accelerated approval by the FDA in September 2021 for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.
FDA Approves Padcev Plus Keytruda for Urothelial Cancer
December 15th 2023The FDA previously granted the application for Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) with priority review and breakthrough designation for patients with locally advanced or metastatic urothelial cancer.
FDA Approves HIF-2α Inhibitor for Patients With Advanced Renal Cell Carcinoma
December 15th 2023The FDA based the approval Merck’s Welireg (belzutifan) on findings from the randomized, open-label, Phase III LITESPARK-005 trial, which compared Welireg to Afinitor for the treatment of advanced RCC that has progressed after prior treatment with PD-1/L1 and VEGF-TKI therapies.
FDA Approves Treatment to Lower Relapse in High-Risk Neuroblastoma
December 14th 2023Eflornithine (Iwilfin) is indicated to lower the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who showed at least a partial response to previous multi-agent and multimodality treatment that included an anti-GD2 immunotherapy.
Investigational Treatment for High-Risk Bladder Cancer Awarded FDA Breakthrough Designation
December 5th 2023Johnson & Johnson’s TAR-200 has a novel targeted releasing system that allows for a controlled release of gemcitabine in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer.