FDA Grants Accelerated Approval to Avmapki Fakzynja Co-pack for Some Ovarian Cancers

The FDA granted accelerated approval to the combination of avutometinib and defactinib for adult patients with ...

MAY 9, 2025

First and Only Ready-to-Dilute, Multi-Dose Vial of Thiotepa Approved

The FDA approved the 100 mg/10 mL multi-dose vial of Tepylute, a ready-to-dilute formulation of thiotepa to treat ...

MAY 8, 2025

Elahere Fully Approved for Certain Ovarian, Fallopian Tube or Primary Peritoneal Cancer

The FDA approved Elahere for adult patients with FRalpha-positive, platinum-resistant epithelial ovarian, fallopian ...

MARCH 25, 2024

FDA Approves Elahere to Treat Platinum-Resistant Ovarian Cancer

Mirvetuximab soravtansine-gynx was approved to treat adults with folate receptor alpha-positive, platinum-resistant ...

NOVEMBER 21, 2022

Zejula Monotherapy Approved for Some Late-Line Gyn Cancers

The FDA granted approval for an expanded indication for the poly(adenosine diphosphate–ribose) polymerase ...

OCTOBER 28, 2019

FDA Approves Avastin Plus Chemo for Certain Women With Advanced Ovarian Cancer

The FDA granted a new indication for Avastin in combination with chemotherapy, followed by Avastin as a single ...

JUNE 14, 2018

FDA Grants New Indication for Rubraca

The FDA granted a new indication for Rubraca for the maintenance treatment of recurrent ovarian, fallopian tube or ...

APRIL 6, 2018

FDA Approves Niraparib for Recurrent Ovarian Cancer

Unlike other PARP inhibitors, niraparib is active in both patients with and without BRCA mutations.

MARCH 29, 2017