FDA grants orphan drug designation to MB-105 for CD5-targeted CAR T-cell therapy

Intermountain Health to expand stem cell collection for CAR-T cell therapy, bringing procedure to southern Utah

Intermountain Health is now offering a national expansion of CAR-T cell therapy, bringing cancer care closer to patients in southern Utah and Nevada.

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

Rewriting the rules of cancer treatment one nanobody at a time

I joined Translational Genomics Research Institute, part of City of Hope, late last year to launch the Center for Accelerated Nanotherapeutics.

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 grants orphan drug designation to MB-105 for CD5-targeted CAR T-cell therapy

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Intermountain Health to expand stem cell collection for CAR-T cell therapy, bringing procedure to southern Utah

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

Rewriting the rules of cancer treatment one nanobody at a time

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

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FDA grants orphan drug designation to MB-105 for CD5-targeted CAR T-cell therapy

YOU MAY BE INTERESTED IN

Intermountain Health to expand stem cell collection for CAR-T cell therapy, bringing procedure to southern Utah

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

Rewriting the rules of cancer treatment one nanobody at a time

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

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