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Latest FDA Oncology Updates

Accepted for Review Oncology Press Release

FDA Accepts NDA for TLX101-Px (Pixclara®) - PR Newswire

FDA Accepts NDA for TLX101-Px (Pixclara®). (PRNewsfoto/Telix Pharmaceuticals ... cancer), and has assigned a PDUFA goal date of September 11, 2026 ...

ODAC Meeting Oncology FDA ODAC

April 30, 2026: Meeting of the Oncologic Drugs Advisory Committee

Event Title. April 30, 2026: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement. April 30, 2026 · On This Page · Agenda · Meeting Materials.

PDUFA Date Oncology Press Release

Savara Announces the U.S. Food & Drug Administration (FDA) Has ...

Such statements include, but are not limited to, statements related to the target PDUFA action date. Savara may not actually achieve any of the matters ...

Approval Heme FDA OCE

FDA approves nivolumab with chemotherapy for Hodgkin lymphoma

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent ...

News Oncology FDA OCE

FDA Oncology Center of Excellence Presents Conversations on ...

FDA Oncology Center of Excellence Presents Conversations on Cancer: Oncology Nurses - Frontliners in Oncology May 6, 2026.

News Oncology FDA OCE

FDA Schedules Public Meeting on the Commissioner's National ...

... Oncology Center of Excellence, as well as a presiding officer. Requests to speak are due by April 24 at 11:59 p.m. The FDA is also soliciting written ...

Approval GYN FDA.gov

FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

On March 25, 2026, the Food and Drug Administration approved relacorilant (Lifyorli, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.

Approval Heme FDA.gov

FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma

On March 20, 2026, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL).

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Oncology News

ctDNA: ZEST Trial Cleans Up Breast Cancer Treatment – Niraparib (ZEJULA) vs. Placebo in High-Risk TNBC and BRCA-Mutated Patients

Breast Cancer 3 Mins Read

The ZEST trial marks a pivotal moment in oncology, focusing on circulating tumor DNA (ctDNA) surveillance to detect molecular residual disease in breast cancer patients. This study explored whether Niraparib, a PARP inhibitor, could extend disease-free survival in patients with detectable ctDNA post-treatment but without visible signs of recurrence. The findings offer insights into both the potential and the limitations of using ctDNA for personalized cancer management.

MOASC - Medical Oncology Association of Southern California

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