Complete Story
12/16/2025
Recent Oncology Related FDA Approvals and Expanded Indications
FDA Approves Amgen’s IMDELLTRA® (tarlatamab-dlle) in Extensive Stage Small Cell Lung Cancer
FDA Approves AstraZeneca’s Koselugo (selumetinib), for the Treatment of Adult Patients with Neurofibromatosis Type 1 (NF1) who have Symptomatic, Inoperable Plexiform
FDA Approves Genmab’s EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide for the Treatment of Relapsed or Refractory Follicular Lymphoma
FDA Approves Merck's KEYTRUDA® (pembrolizumab) with enfortumab vedotin-ejfv for Muscle Invasive Bladder Cancer
FDA Approves AstraZeneca's Imfinzi (durvalumab) for Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
FDA approves Lilly’s expanded indication for Jaypirca (pirtobrutinib) for adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor
FDA Approves Johnson & Johnson's Niraparib and Abiraterone Acetate Plus Prednisone for BRCA2-mutated Metastatic Castration-sensitive Prostate Cancer
FDA Approves Daiichi Sankyo's ENHERTU® Plus Pertuzumab Approved in the U.S. for First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer
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