FDA Grants Accelerated Approval to Zongertinib for Non-Squamous NSCLC With HER2 TKD Activating Mutations
FDA Grants Accelerated Approval to Dordaviprone for Diffuse Midline Glioma
FDA Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs Within Bristol Myers Squibb’s Cell Therapy Labels
FDA Grants Accelerated Approval to Sunvozertinib for Metastatic Non-Small Cell Lung Cancer
FDA Grants Accelerated Approval to Linvoseltamab-gcpt for Relapsed or Refractory Multiple Myeloma
FDA Grants Accelerated Approval to Datopotamab Deruxtecan-dlnk for EGFR-Mutated Non-Small Cell Lung Cancer
FDA Approves Tafasitamab-cxix for Relapsed or Refractory Follicular Lymphoma
FDA Approves Mitomycin Intravesical Solution for Recurrent Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
FDA Approves Tablet Formulation of Zanubrutinib for All Approved Indications
FDA Approves Taletrectinib for ROS1-positive Non-small Cell Lung Cancer
FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer
FDA Approves Retifanlimab-dlwr With Carboplatin and Paclitaxel and as a Single Agent for Squamous Cell Carcinoma of the Anal Canal
FDA Grants Accelerated Approval to Telisotuzumab Vedotin-tllv for NSCLC With High c-Met Protein Overexpression
FDA Approves Belzutifan for Pheochromocytoma or Paraganglioma
FDA Grants Accelerated Approval to the Combination of Avutometinib and Defactinib for Select Patients With Ovarian Cancer
FDA Approves Penpulimab-kcqx for Non-Keratinizing Nasopharyngeal Carcinoma
FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic Hepatocellular Carcinoma
FDA Approves Larotrectinib for Adult and Pediatric Patients With NTRK Gene Fusion-Positive Solid Tumors
FDA Expands Pluvicto’s Metastatic Castration-Resistant Prostate Cancer Indication
FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer
FDA Approves Durvalumab for Muscle-Invasive Bladder Cancer
FDA Approves Cabozantinib for Pancreatic and Extra-Pancreatic Neuroendocrine Tumors
FDA Approves Pembrolizumab for HER2 Positive Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1
Geron Announces European Commission Approval of Imetelstat for the Treatment of Adults With Transfusion-Dependent Anemia
FDA Approves Tislelizumab-jsgr for First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma in Combination With Chemotherapy
FDA Approves Fam-Trastuzumab Deruxtecan-Nxki for Unresectable or Metastatic HR-positive, HER2-low or HER2-ultralow Breast Cancer
FDA Approves Vimseltinib for Symptomatic Tenosynovial Giant Cell Tumor
FDA Approves Mirdametinib for Select Adult and Pediatric Patients With Neurofibromatosis Type 1
FDA Approves Brentuximab Vedotin With Lenalidomide and Rituximab for Relapsed or Refractory Large B-Cell Lymphoma
FDA Approves Treosulfan With Fludarabine as a Preparative Regimen for alloHSCT in Adult and Pediatric Patients with AML or MDS
