FDA approves prostate cancer imaging agent Gozellix

The Directors: Tom Lynch and Skip Burris on how NIH funding cuts imperil biopharma innovation—and cost patient lives
In a time of uncertainty, “react to the knowns, not the fear”

Thomas J. Lynch Jr. and Howard A. “Skip” Burris III lead two institutions that couldn’t be more different—an NCI-designated Comprehensive Cancer Center on one side of the country and a for-profit research enterprise on the other—but they stay up at nights worrying about the same thing.

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.

May 09, 2025

Vol.51 No.18

By Jacquelyn Cobb

FDA approves prostate cancer imaging agent Gozellix

YOU MAY BE INTERESTED IN

The Directors: Tom Lynch and Skip Burris on how NIH funding cuts imperil biopharma innovation—and cost patient lives
In a time of uncertainty, “react to the knowns, not the fear”

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

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FDA approves prostate cancer imaging agent Gozellix

YOU MAY BE INTERESTED IN

The Directors: Tom Lynch and Skip Burris on how NIH funding cuts imperil biopharma innovation—and cost patient livesIn a time of uncertainty, “react to the knowns, not the fear”

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

Never miss an issue!

Login

The Directors: Tom Lynch and Skip Burris on how NIH funding cuts imperil biopharma innovation—and cost patient lives
In a time of uncertainty, “react to the knowns, not the fear”

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