- 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
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the March 3, 2023, FDA approval of Verzenio (abemaciclib) with endocrine therapy for patients with HR-positive, HER2-negative, node-positive, early breast cancer.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the February 9, 2023, FDA approval of Jemperli (dostarlimab-gxly) for mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the February 3, 2023, FDA approval of Trodelvy (sacituzumab govitecan-hziy) for HR-positive breast cancer.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the January 27, 2023, FDA approvals of Jaypirca (pirtobrutinib) for relapsed or refractory mantle cell lymphoma, and Orserdu (elacestrant) for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the January 26, 2023, FDA approval of Keytruda (pembrolizumab) as adjuvant treatment for non-small cell lung cancer
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the January 19, 2023, FDA approvals of Tukysa (tucatinib) with trastuzumab for colorectal cancer and Brukinsa (zanubrutinib) for chronic lymphocytic leukemia or small lymphocytic lymphoma.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the December 9 and 12, 2022, FDA approvals of Tecentriq (atezolizumab) for unresectable or metastatic alveolar soft part sarcoma, and Krazati (adagrasib) for KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer”
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the December 16, 2022, FDA approval of Adstiladrin (nadofaragene firadenovec-vncg) for patients with high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the December 22, 2022, FDA approval of Lunsumio (mosunetuzumab-axgb) for ipatients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.”
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the December 14, 2022, FDA approval of Xeloda (capecitabine) under Project Renewal, an initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the December 1, 2022, FDA approval of Rezlidhia (olutasidenib) for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation.
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchFDA D.I.S.C.O. Burst Edition: FDA approval of Elahere (mirvetuximab soravtansine-gynx) for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer
- by U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchListen to a soundcast of the November 18, 2022 FDA approval of a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant).