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Drugs & Targets

FDA approves relacorilant + nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

March 27, 2026
Vol.52 No.12
Drugs & Targets

FDA approves label update to accelerate thaw time for Adstiladrin gene therapy for NMIBC

March 27, 2026
Vol.52 No.12
FDA launches consolidated adverse event reporting system
Cancer Policy

FDA launches consolidated adverse event reporting system

March 20, 2026
Vol.52 No.11
By Claire Marie Porter
CBER Director Vinay Prasad dared to “say no to drugs”
Podcast

CBER Director Vinay Prasad dared to “say no to drugs”

March 18, 2026
Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again)
Regulatory News

Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again)

March 13, 2026
Vol.52 No.10
By Claire Marie Porter
Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Regulatory News

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

March 13, 2026
Vol.52 No.10
By Jacquelyn Cobb
FDA approves leucovorin for cerebral folate deficiency
Cancer Policy

FDA approves leucovorin for cerebral folate deficiency

March 13, 2026
Vol.52 No.10
By Claire Marie Porter
Drugs & Targets

FDA approves teclistamab + daratumumab hyaluronidase-fihj for r/r MM

March 06, 2026
Vol.52 No.09
Drugs & Targets

FDA grants tentative approval for Lutetium Lu 177 dotatate

March 06, 2026
Vol.52 No.09
Cancer Policy

FDA issues draft guidance on accelerating development of individualized therapies for ultra-rare diseases

February 27, 2026
Vol.52 No.08

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