BCMA CAR-T Archives

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Dr. Omar Nadeem presenting CARPRISM trial results showing 100% MRD negativity with ciltacabtagene autoleucel (cilta-cel) in patients with high-risk smoldering multiple myeloma at AACR 2026

CARPRISM Trial: Can Cilta-cel Deliver Universal MRD Negativity and Prevent Progression in High-Risk Smoldering Multiple Myeloma?

AACR 4 Mins Read

High-risk smoldering multiple myeloma (HR-SMM) carries a roughly 50% risk of progression to active disease within two years. Until recently,…

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 ...

Filed: Sep 11, 2026 View source on FDA.gov →

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.

Meeting: Apr 30, 2026 View source on FDA.gov →

CRL Skin Press Release

Replimune Receives Complete Response Letter from the FDA

Replimune Receives Complete Response Letter from the FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma. 10 avr. 2026 17h02 HE | ...

View source on FDA.gov →

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 ...

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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 ...

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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 ...

View source on FDA.gov →

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.

View source on FDA.gov →

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.

Approved: Mar 25, 2026 View source on FDA.gov →