Stephen M. Hahn, MD, Confirmed as FDA Commissioner
December 12, 2019
Stephen M. Hahn, MD, from The University of Texas MD Anderson Cancer Center, will take over as Commissioner of the FDA, voted on by the Senate on Thursday.
FDA
Niraparib for Advanced Ovarian Cancer with HRD+ Status Approved by FDA
October 23, 2019
Niraparib was approved by the (FDA) for previously treated advanced ovarian, fallopian, or primary peritoneal cancers.
FDA Grants Priority Review to Trastuzumab Deruxtecan for HER2+ Metastatic Breast Cancer
October 17, 2019
The agency is set to make a decision on the investigational antibody drug conjugate by the first quarter of 2020.
FDA Grants Breakthrough Therapy Designation to Niraparib for mCRPC
October 4, 2019
The agency granted breakthrough therapy designation to niraparib for the treatment of men with BRCA1/2-mutant positive metastatic castration-resistant prostate cancer.
Project Orbis Enables First International Approval in U.S., Canada, Australia
September 19, 2019
The first-of-its-kind collaboration led to the approval of a combination therapy for patients with endometrial cancer.
FDA Approves Apalutamide for Prostate Cancer
September 18, 2019
Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer; the recent approval is for patients with metastatic castration-sensitive prostate cancer.
Pembrolizumab Plus Lenvatinib Approved for Endometrial Cancer
September 17, 2019
The combination was simultaneously approved in Australia and Canada and was the first such action under a new international collaboration.
Keytruda (Pembrolizumab) Issued New Dosage and Indication
April 22, 2019
The FDA has recently approved new dosage form and two new indications for the drug.
Balversa Fast-Tracked for Bladder Cancer
April 12, 2019
Erdafitinib is first targeted therapy for FGFR3 or FGFR2 genetic alteration.
