FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for multiple myeloma
On July 30, 2024, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj in combination with…
Browsing: FDA Approvals
FDA-mandated CAR-T monitoring period could be halved
In patients with diffuse large B-cell non-Hodgkin lymphoma (DLBCL), the two hallmark post-chimeric antigen receptor…
FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma
On June 26, 2024, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp, a…
FDA approves selpercatinib for RET fusion-positive thyroid cancer
On June 12, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo,…
FDA grants accelerated approval to selpercatinib for paediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumours
On May 29, 2024, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo,…
FDA approves lisocabtagene maraleucel for relapsed or refractory mantle cell lymphoma
On May 30, 2024, the US Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno…
Recent FDA committee vote could speed multiple myeloma drug approval
A U.S. Food and Drug Administration committee voted unanimously in April to approve a new…
FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer
On April 29, 2024, the Food and Drug Administration granted traditional approval to tisotumab vedotin-tftv…
FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer
On April 18, 2024, the Food and Drug Administration approved alectinib for adjuvant treatment following…
FDA approves immunotherapy drug combo for non-muscle invasive bladder cancer
The U.S. Food and Drug Administration (FDA) has approved the immunotherapy-boosting drug N-803, to be…