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FDA to remove black box warnings on hormone therapy for menopause
Regulatory News

FDA to remove black box warnings on hormone therapy for menopause
Trump-era “gold standard science” is not to be confused with gold standard of scientific evidence

November 14, 2025
Vol.51 No.42
By Claire Marie Porter
Smoldering multiple myeloma: Rethinking the waiting game
Trials & Tribulations

Smoldering multiple myeloma: Rethinking the waiting game

November 14, 2025
Vol.51 No.42
By C. Ola Landgren
Drugs & Targets

FDA approves Komzifti for r/r NPM1-mutated AML

November 14, 2025
Vol.51 No.42
Tidmarsh is out, Pazdur is in: FDA’s CDER under new leadership
Podcast

Tidmarsh is out, Pazdur is in: FDA’s CDER under new leadership

November 12, 2025
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FDA publishes draft guidance to accelerate biosimilar development and lower costs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

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