FDA approval

May 12, 2020January 12, 2021

FDA Approves Lynparza Combo as First-line Maintenance Therapy for Advanced Ovarian Cancer

News

The U.S. Food and Drug Administration (FDA) has approved Lynparza (olaparib), in combination with bevacizumab, as a first-line maintenance therapy for women with advanced ovarian cancer positive for homologous recombination deficiency (HRD) and who responded to platinum-based chemotherapy. This ... Read more

April 30, 2020May 12, 2020

FDA Approves Zejula as First-line Maintenance Therapy for Advanced Ovarian Cancer

News

The U.S. Food and Drug Administration (FDA) has approved Zejula (niraparib) as a first-line maintenance therapy for women with advanced ovarian cancer who responded to platinum-based chemotherapy, regardless of their BRCA mutation status. This indication ... Read more

October 25, 2019

FDA Approves Zejula as Late-Line Treatment for Recurrent Ovarian Cancer Patients

News

The U.S. Food and Drug Administration (FDA) has approved Zejula (niraparib) as a late-line treatment for women with advanced ovarian, fallopian tube, or primary peritoneal cancer who have tumors defective in DNA ... Read more

January 4, 2019

Lynparza Approved in U.S. as First-line Maintenance Therapy for BRCA-positive Advanced Ovarian Cancer

News

Women with BRCA-mutated advanced ovarian cancer living in the United States can now receive Lynparza (olaparib), developed by AstraZeneca and Merck, as a maintenance treatment for their partial or complete response to first-line ... Read more

July 12, 2017July 13, 2017

FDA Expands Use of DigniCap to Prevent Chemotherapy-induced Hair Loss

News

The DigniCap Cooling System, a scalp-cooling system designed by Dignitana to reduce hair loss due to chemotherapy, was cleared by the U.S. Food and Drug Administration (FDA) to be used ... Read more

April 26, 2017

Diplomat Pharmacy to Distribute Recently Approved PARP Inhibitor Zejula in the US

News

Diplomat Pharmacy will be one of the companies distributing Zejula (niraparib), a recently approved treatment for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in the United ... Read more

March 29, 2017March 29, 2017

FDA Approves Zejula as Maintenance Therapy for Ovarian, Other Women’s Cancers

News

The United States has approved Tesaro’s Zejula (niraparib) as a maintenance therapy for adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. The Federal Drug Administration sign-off indicates that regulators ... Read more

December 8, 2016December 8, 2016

FDA’s Approval of Avastin for Ovarian Cancer Offers New Hope, Treatment Option

News

The U.S. Food and Drug Administration (FDA) approved Genentech’s Avastin in combination with chemotherapy for the treatment of platinum-sensitive recurrent ovarian cancer (psOC). This marks the first new psOC treatment option ... Read more