Julie Beitz named principal drug regulatory expert at Hyman, Phelps & McNamara

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

Drugs & Targets

FDA approves Blenrep combination for relapsed/refractory multiple myeloma after two or more lines of therapy

FDA approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

October 24, 2025

Vol.51 No.39

Drugs & Targets

CHMP adopts positive opinion for Libtayo as adjuvant treatment for high-risk CSCC

Regeneron Pharmaceuticals announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells.

October 24, 2025

Vol.51 No.39

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

Julie Beitz named principal drug regulatory expert at Hyman, Phelps & McNamara

YOU MAY BE INTERESTED IN

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

FDA approves Blenrep combination for relapsed/refractory multiple myeloma after two or more lines of therapy

CHMP adopts positive opinion for Libtayo as adjuvant treatment for high-risk CSCC

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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Julie Beitz named principal drug regulatory expert at Hyman, Phelps & McNamara

YOU MAY BE INTERESTED IN

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

FDA approves Blenrep combination for relapsed/refractory multiple myeloma after two or more lines of therapy

CHMP adopts positive opinion for Libtayo as adjuvant treatment for high-risk CSCC

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

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