FDA grants priority review to HER2-directed therapy as first-line treatment of HER2-positive metastatic breast cancer

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

Drugs & Targets

FDA approves Zepzelca + Tecentriq combination as first-line maintenance therapy for ES-SCLC

FDA has granted a approval for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as a maintenance treatment for adults with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.

October 03, 2025

Vol.51 No.36

Drugs & Targets

FDA approves Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

FDA has approved Inluriyo (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy.

October 03, 2025

Vol.51 No.36

FDA grants priority review to HER2-directed therapy as first-line treatment of HER2-positive metastatic breast cancer

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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

FDA approves Zepzelca + Tecentriq combination as first-line maintenance therapy for ES-SCLC

FDA approves Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

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FDA grants priority review to HER2-directed therapy as first-line treatment of HER2-positive metastatic breast cancer

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

FDA approves Zepzelca + Tecentriq combination as first-line maintenance therapy for ES-SCLC

FDA approves Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

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