Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

Shorter radiation therapy after prostate surgery safe, UCLA study finds

For men who undergo a radical prostatectomy for the treatment of prostate cancer, post-surgery radiation therapy can play a vital role in reducing the risk of recurrence.

May 16, 2025

Vol.51 No.19

Drugs & Targets

FDA approves Emrelis for previously treated, advanced NSCLC with high c-Met protein overexpression

FDA granted accelerated approival to Emrelis (telisotuzumab vedotin-tllv) for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer with high c-Met protein overexpression who have received a prior systemic therapy.

May 16, 2025

Vol.51 No.19

Drugs & Targets

FDA approves Zynyz as first-line treatment for advanced anal cancer

FDA approved Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1, in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal.

May 16, 2025

Vol.51 No.19

Regulatory News

Cyber-iconoclast Vinay Prasad named head of FDA’s CBER
An oncologist, Prasad has criticized accelerated approval, next-gen sequencing, and targeted therapies

Vinay Prasad, a MAHA-aligned hematologist-oncologist with an avid cyber following, was named director of the FDA Center for Biologics Evaluation and Research, where he will be responsible for the agency’s regulation of vaccines and biologics, including cell and gene therapies.

May 09, 2025

Vol.51 No.18

By Claire Marie Porter

Cancer Policy

Scott Gottlieb, Mark McClellan warn of the major challenges created by planned reorganization of FDA

Scott GottliebMark B. McClellanTwo former FDA commissioners—Scott Gottlieb and Mark B. McClellan—warned that the Trump administration’s proposal to restructure FDA by consolidating the different product centers that review drugs, biologics, animal health, tobacco, and medical devices into a single regulatory office would lead to major challenges.

First ODAC meeting since Trump’s inauguration scheduled for May 20-21

FDA announced a meeting of the Oncologic Drugs Advisory Committee May 20 and 21. It will be the first ODAC meeting since President Trump was inaugurated.

May 09, 2025

Vol.51 No.18

By Jacquelyn Cobb

Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

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Shorter radiation therapy after prostate surgery safe, UCLA study finds

FDA approves Emrelis for previously treated, advanced NSCLC with high c-Met protein overexpression

FDA approves Zynyz as first-line treatment for advanced anal cancer

Cyber-iconoclast Vinay Prasad named head of FDA’s CBER
An oncologist, Prasad has criticized accelerated approval, next-gen sequencing, and targeted therapies

Scott Gottlieb, Mark McClellan warn of the major challenges created by planned reorganization of FDA

First ODAC meeting since Trump’s inauguration scheduled for May 20-21

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Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

YOU MAY BE INTERESTED IN

Shorter radiation therapy after prostate surgery safe, UCLA study finds

FDA approves Emrelis for previously treated, advanced NSCLC with high c-Met protein overexpression

FDA approves Zynyz as first-line treatment for advanced anal cancer

Cyber-iconoclast Vinay Prasad named head of FDA’s CBERAn oncologist, Prasad has criticized accelerated approval, next-gen sequencing, and targeted therapies

Scott Gottlieb, Mark McClellan warn of the major challenges created by planned reorganization of FDA

First ODAC meeting since Trump’s inauguration scheduled for May 20-21

Never miss an issue!

Login

Cyber-iconoclast Vinay Prasad named head of FDA’s CBER
An oncologist, Prasad has criticized accelerated approval, next-gen sequencing, and targeted therapies