Cancer Policy Makary, Prasad describe FDA’s new “plausible mechanism pathway” to get bespoke therapies to market sans RCT November 21, 2025Vol.51 No.43By Jacquelyn Cobb
Drugs & Targets FDA approves Poherdy, first biosimilar to Perjeta, for breast cancer indication November 21, 2025Vol.51 No.43
Drugs & Targets FDA approves epcoritamab-bysp for follicular lymphoma indications November 21, 2025Vol.51 No.43
Podcast Ellen Sigal and Karen Knudsen “gush” about new CDER Director Richard Pazdur and his late wife, Mary November 19, 2025
Conversation with The Cancer LetterRegulatory News Richard Pazdur, a respected insider with a plan to reengineer FDA, steps in as CDER director November 14, 2025Vol.51 No.42By Paul Goldberg
Guest Editorial Rick Pazdur’s CDER appointment comes at exactly the right moment for FDA November 14, 2025Vol.51 No.42By Ellen V. Sigal
Regulatory News FDA to remove black box warnings on hormone therapy for menopauseTrump-era “gold standard science” is not to be confused with gold standard of scientific evidence November 14, 2025Vol.51 No.42By Claire Marie Porter
Trials & Tribulations Smoldering multiple myeloma: Rethinking the waiting game November 14, 2025Vol.51 No.42By C. Ola Landgren
