FDA Approvals, News & Updates
On November 18, 2025, the FDA approved epcoritamab-bysp (Epkinly) in combination with lenalidomide and rituximab (R2) for relapsed or refractory follicular lymphoma (FL). Read More ›
On November 19, 2025, the FDA granted traditional approval to tarlatamab-dlle (Imdelltra) for adults with extensive-stage small cell lung cancer that progressed after platinum-based chemotherapy. Read More ›
On November 19, 2025, the FDA granted accelerated approval to sevabertinib (Hyrnuo), a kinase inhibitor, for adults with locally advanced or metastatic non-squamous non–small cell lung cancer (NSCLC) with HER2 tyrosine kinase domain (TKD)-activating mutations, as identified by an FDA-approved test, who had received prior systemic therapy. Read More ›
On November 21, 2025, the FDA approved pembrolizumab (Keytruda), or pembrolizumab with berahyaluronidase alfa-pmph (Keytruda Qlex), in combination with enfortumab vedotin-ejfv (Padcev), as neoadjuvant therapy followed by adjuvant therapy after cystectomy for adults with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. Read More ›
On December 3, 2025, the FDA granted traditional approval to pirtobrutinib (Jaypirca) for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously treated with a covalent BTK inhibitor. Read More ›
On November 6, 2025, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adults with high-risk smoldering multiple myeloma (SMM). Darzalex Faspro is only indicated for patients with high-risk SMM. It is not indicated for other risk categories. Read More ›
On October 23, 2025, the FDA approved belantamab mafodotin-blmf (Blenrep) in combination with bortezomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma. This approval applies to patients who have received at least 2 prior therapies, including a proteasome inhibitor and an intermodulary agent. Read More ›
On October 24, 2025, the FDA approved revumenib (Revuforj) for the treatment of adult and pediatric patients aged 1 years and older with relapsed or refractory acute myeloid leukemia (AML) characterized by a susceptible nucleophosmin 1 (NPM1) mutation with no satisfactory alternative treatment options. Read More ›
Officials with the FDA have granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway) for adults with locally advanced or metastatic EGFR-mutated non–small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. Read More ›
The FDA has granted accelerated approval to linvoseltamab-gcpt (Lynozyfic), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed/refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody. Read More ›