FDA Approvals, News & Updates
On February 24, 2026, the FDA granted traditional approval to encorafenib (Braftovi) in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adults with metastatic colorectal cancer (CRC) harboring a BRAF V600E mutation, as determined by an FDA-authorized test. Read More ›
On February 19, 2026, the FDA approved the combination of acalabrutinib (Calquence) and venetoclax (Venclexta) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Read More ›
On March 5, 2026, the FDA approved teclistamab (Tecvayli) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. Read More ›
On February 26, 2026, the FDA granted accelerated approval to zongertinib (Hernexeos), a kinase inhibitor, for adults with unresectable or metastatic nonsquamous non–small cell lung cancer (NSCLC) harboring HER2 tyrosine kinase domain (TKD)-activating mutations. Read More ›
On March 11, 2026, the FDA announced the launch of the FDA Adverse Event Monitoring System (AEMS), a unified platform designed to modernize and streamline the agency’s analysis of adverse event reports. Read More ›
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 ›