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CDER Director Tidmarsh quits amid inspector general probe of his “personal conduct”
Regulatory News

CDER Director Tidmarsh quits amid inspector general probe of his “personal conduct”
Cancer advocates express concern about comments that signal trouble for accelerated approval

November 07, 2025
Vol.51 No.41
By Claire Marie Porter and Paul Goldberg
How George Tidmarsh crossed the FDA-industry Rubicon
Guest Editorial

How George Tidmarsh crossed the FDA-industry Rubicon

November 07, 2025
Vol.51 No.41
By Mikkael A. Sekeres
Cancer Policy

Zongertinib, dostarlimab chosen in second batch of National Priority Vouchers recipients

November 07, 2025
Vol.51 No.41
By Jacquelyn Cobb
Drugs & Targets

FDA approves Darzalex Faspro for high-risk smoldering multiple myeloma

November 07, 2025
Vol.51 No.41
Friends publishes three white papers ahead of annual meeting

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

October 31, 2025
Vol.51 No.40
By Sara Willa Ernst
Drugs & Targets

FDA publishes draft guidance to accelerate biosimilar development and lower costs

October 31, 2025
Vol.51 No.40
Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA
Cancer Policy

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

October 24, 2025
Vol.51 No.39
By Claire Marie Porter
Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research
Regulatory NewsTrials & Tribulations

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

October 17, 2025
Vol.51 No.38
By Edison T. Liu
How animal testing became a MAHA political wedge issue
News AnalysisRegulatory 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

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

October 17, 2025
Vol.51 No.38

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