FDA Approvals

The FDA has granted accelerated approval to vusolimogene oderparepvec plus nivolumab for patients with unresectable advanced cutaneous melanoma that has progressed following PD-1-blockade, based on durable responses observed in the phase 2...

The FDA has approved a rituximab biosimilar referencing Rituxan for multiple hematologic malignancies and autoimmune diseases. Approval was supported by a comprehensive biosimilar development program demonstrating high similarity and no...

The FDA has approved lutetium Lu 177 vipivotide tetraxetan in combination with androgen receptor pathway inhibitor therapy for patients with PSMA-positive metastatic hormone-sensitive prostate cancer. The approval was based on results from...

The FDA approved zidesamtinib for adults with previously treated locally advanced or metastatic ROS1-positive non-small cell lung cancer based on findings from the phase 1/2 ARROS-1 trial demonstrating durable responses, including in patients...

The FDA approved gedatolisib in combination with fulvestrant, with or without palbociclib, for patients with PIK3CA wild-type HR-positive, HER2-negative advanced or metastatic breast cancer based on the phase 3 VIKTORIA-1 trial demonstrating...

The FDA granted traditional approval to selpercatinib for adults and children aged 2 years and older with previously treated RET fusion-positive solid tumors based on durable responses observed across multiple tumor types in the LIBRETTO-001...

The FDA approved ENNUMO, a biosimilar to pegfilgrastim, for the same indications as the reference product, providing an additional granulocyte colony-stimulating factor option to reduce febrile neutropenia during myelosuppressive chemotherapy...

The FDA approved perioperative pembrolizumab plus enfortumab vedotin for patients with muscle-invasive bladder cancer undergoing cystectomy based on results from the phase 3 KEYNOTE-B15/EV-304 trial demonstrating significant improvements in...

The FDA has approved subcutaneous isatuximab for three treatment indications in multiple myeloma, including in combination with pomalidomide and dexamethasone, carfilzomib and dexamethasone, or bortezomib, lenalidomide, and dexamethasone.

The FDA has approved a prefilled pen for ropeginterferon alfa-2b-njft in adult patients with polycythemia vera, providing a new option designed to simplify self-administration of chronic interferon therapy.