FDA Approvals, News & Updates
On July 10, 2026, the FDA approved pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), each in combination with enfortumab vedotin-ejfv (Padcev), as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle-invasive bladder cancer (MIBC). Read More ›
On July 14, 2026, the FDA granted traditional approval to selpercatinib (Retevmo) for adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors harboring a RET gene fusion, as detected by an FDA-approved test, after progression on prior systemic therapy or when no satisfactory alternative treatment options are available. Read More ›
On July 14, 2026, the FDA approved gedatolisib (Revtorpyk) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation after progression on or after at least 1 line of endocrine therapy in the metastatic setting. Read More ›
On July 22, 2026, the FDA approved zidesamtinib (Jideytro) for adults with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC) who have received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI). Read More ›
Daraxonrasib (Rasonque) is now FDA approved for adults with metastatic pancreatic adenocarcinoma after prior systemic therapy or for those who are not candidates for multiagent regimens. Read More ›
On May 28, 2026, the FDA approved durvalumab (Imfinzi) in combination with bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-naive, high-risk non-muscle invasive bladder cancer (NMIBC). Read More ›
On May 27, 2026, the FDA approved pivekimab sunirine-pvzy (Decnupaz) for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra-rare hematologic malignancy. Read More ›
On May 22, 2026, the FDA approved datopotamab deruxtecan-dlnk (Datroway) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Read More ›
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 ›