FDA grants Fast Track Designation to UB-VV111 in vivo CAR T-cell therapy

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

Earlier this year, FDA announced that it would be initiating a voucher program aimed at accelerating review time for applications that are deemed to be advancing U.S. “national priorities” (The Cancer Letter, June 20, 2025).

October 24, 2025

Vol.51 No.39

By Claire Marie Porter

Clinical Regulatory News Trials & Tribulations

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

In April 2025, announcements from the two most influential biomedical agencies in the US, the FDA and the NIH, declared that both will seek to reduce and minimize animal-based testing and experimentation. These declarations sparked joy in some circles, and deep concern in others that was reflected in a 28% fall in the share price of Charles River Labs (NYSE: NYSE:CRL).

October 17, 2025

Vol.51 No.38

By Edison T. Liu

News Analysis Regulatory News

How animal testing became a MAHA political wedge issue
While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough

Bowing to the growing animal rights movement, FDA and NIH have made policy changes to discourage animal testing, instead favoring alternative research models.

October 17, 2025

Vol.51 No.38

By Claire Marie Porter and Jacquelyn Cobb

Drugs & Targets

FDA requires a boxed warning for immune effector cell-associated enterocolitis following Carvykti treatment

FDA has received reports of immune effector cell-associated enterocolitis in patients who received treatment with Carvykti.

October 17, 2025

Vol.51 No.38

Clinical Roundup

Next-gen CAR T cells show promise at treating solid tumors, USC study shows

Using cell cultures and animal models, researchers from the USC Norris Comprehensive Cancer Center at Keck School of Medicine of USC showed that next-generation CAR T cells can safely and effectively shrink solid tumors.

October 10, 2025

Vol.51 No.37

The evolution of cellular immunotherapy: From transplant to CAR T cells

Nearly five decades ago, I joined City of Hope’s nascent bone marrow transplant (BMT) program, which focused on improving outcomes for patients with advanced leukemia.

October 03, 2025

Vol.51 No.36

By Stephen J. Forman

FDA grants Fast Track Designation to UB-VV111 in vivo CAR T-cell therapy

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Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

How animal testing became a MAHA political wedge issue
While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough

FDA requires a boxed warning for immune effector cell-associated enterocolitis following Carvykti treatment

Next-gen CAR T cells show promise at treating solid tumors, USC study shows

The evolution of cellular immunotherapy: From transplant to CAR T cells

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FDA grants Fast Track Designation to UB-VV111 in vivo CAR T-cell therapy

YOU MAY BE INTERESTED IN

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

How animal testing became a MAHA political wedge issueWhile cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough

FDA requires a boxed warning for immune effector cell-associated enterocolitis following Carvykti treatment

Next-gen CAR T cells show promise at treating solid tumors, USC study shows

The evolution of cellular immunotherapy: From transplant to CAR T cells

Never miss an issue!

Login

How animal testing became a MAHA political wedge issue
While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough