FDA Approvals, News & Updates
On February 12, 2026, the FDA approved Optune Pax, a portable, wearable device that delivers tumor treating fields (TTFields), for the treatment of adult patients with locally advanced pancreatic cancer in combination with gemcitabine and nab-paclitaxel. Read More ›
On February 10, 2026, the FDA approved pembrolizumab (Keytruda) and pembrolizumab with berahyaluronidase alfa-pmph (Keytruda Qlex) in combination with paclitaxel, with or without bevacizumab, for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumors express PD-L1 (CPS≥1) and who have received 1 or 2 prior systemic treatments. Read More ›
On January 27, 2026, the FDA approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). Read More ›
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 ›