FDA approves selumetinib for pediatric neurofibromatosis indication

Friends publishes three white papers ahead of annual meeting
Topics: Clinical trials on rare cancers, combination drug trials, multi-regional studies

The Friends of Cancer Research annual meeting, to be held Nov. 4 in Washington, DC, will focus on three questions facing the field of oncology clinical trial design.

FDA publishes draft guidance to accelerate biosimilar development and lower costs

In a new draft guidance, FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.

October 31, 2025

Vol.51 No.40

Cancer Policy

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

FDA approves selumetinib for pediatric neurofibromatosis indication

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Friends publishes three white papers ahead of annual meeting
Topics: Clinical trials on rare cancers, combination drug trials, multi-regional studies

FDA publishes draft guidance to accelerate biosimilar development and lower costs

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

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FDA approves selumetinib for pediatric neurofibromatosis indication

YOU MAY BE INTERESTED IN

Friends publishes three white papers ahead of annual meetingTopics: Clinical trials on rare cancers, combination drug trials, multi-regional studies

FDA publishes draft guidance to accelerate biosimilar development and lower costs

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

Never miss an issue!

Login

Friends publishes three white papers ahead of annual meeting
Topics: Clinical trials on rare cancers, combination drug trials, multi-regional studies

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