- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the 12.18.2024 FDA approval of Ryoncil (remestemcel-L-rknd) for steroid-refractory acute graft versus host disease in pediatric patients.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchFDA D.I.S.C.O. Burst Edition: FDA approval of Bizengri (zenocutuzumab-zbco) for Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the 8.2.2024 FDA approval of Tecelra (afamitresgene autoleucel) for unresectable or metastatic synovial sarcoma.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the 9.17.2024 FDA approval of Keytruda (pembrolizumab) for unresectable advanced or metastatic malignant pleural mesothelioma.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the June 13, 2024, and June 21, 2024, Augtyro (repotrectinib) for NTRK gene fusion-positive solid tumors and Krazati (adagrasib) for KRAS G12C-mutated colorectal cancer.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the May 29, 2024, FDA approval of Retevmo (selpercatinib) for patients with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the April 23, 2024, FDA approval of Ojemda (tovorafenib) for relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the April 5, 2024, FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-positive solid tumors.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the November 27, 2023 FDA approval of OGSIVEO (nirogacestat) for adult patients with progressing desmoid tumors who require systemic treatment.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchFDA D.I.S.C.O. Burst Edition: FDA approval of Augtyro (repotrectinib) for locally advanced or metastatic ROS1-positive non-small cell lung cancer
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchFDA D.I.S.C.O. Burst Edition: FDA approval of Fruzaqla (fruquintinib) for adult patients with metastatic colorectal cancer
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchFDA D.I.S.C.O. Burst Edition: FDA approval of Tibsovo (ivosidenib) for patients with relapsed or refractory myelodysplastic syndromes with a susceptible isocitrate dehydrogenase-1 mutation
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchFDA D.I.S.C.O. Burst Edition: FDA approvals of Talvey (talquetamab-tgvs) for relapsed or refractory multiple myeloma, and Elrexfio (elranatamab-bcmm) for relapsed or refractory multiple myeloma
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the May 31, 2023, FDA approval of Lynparza (olaparib), with abiraterone and prednisone, for BRCA-mutated metastatic castration-resistant prostate cancer.”
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the May 19, 2023, FDA approval of Epkinly (epcoritamab-bysp) for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the April 19, 2023, FDA approval of Polivy (polatuzumab vedotin-piiq) for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the April 17, 2023, FDA approval of Omisirge (omidubicel-onlv) to reduce time to neutrophil recovery and infection in patients with hematologic malignancies.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the April 19, 2023, FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial carcinoma.”
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchLsten to a soundcast of the March 22, 2023 FDA approval of Zynyz (retifanlimab-dlwr) for metastatic or recurrent locally advanced Merkel cell carcinoma.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the March 16, 2023, FDA approval of Tafinlar (dabrafenib) for pediatric patients with low-grade glioma with a BRAF V600E mutation