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FDA tells sponsors of CAR T-cell therapies to add boxed warning about secondary T-cell malignancies
Regulatory News

FDA tells sponsors of CAR T-cell therapies to add boxed warning about secondary T-cell malignancies

February 02, 2024
Vol.50 No.05
By Alexandria Carolan
Reflecting on Janet Woodcock’s retirement from FDA
Guest Editorial

Reflecting on Janet Woodcock’s retirement from FDA

January 26, 2024
Vol.50 No.04
By Ellen V. Sigal
Drugs & Targets

FDA approves Balversa for locally advanced or metastatic urothelial carcinoma

January 26, 2024
Vol.50 No.04
In Brief

Kelly Norsworthy named acting associate director for research mentorship in FDA’s Oncology Center of Excellence

January 19, 2024
Vol.50 No.03
Drugs & Targets

FDA approves Keytruda + chemoradiotherapy for FIGO 2014 stage 3-4A cervical cancer

January 19, 2024
Vol.50 No.03
Heated discussion breaks out in recent meeting as FDA mulls standards for MCD approval
Regulatory News

Heated discussion breaks out in recent meeting as FDA mulls standards for MCD approval
Meanwhile, NCI trial will assess clinical utility

January 12, 2024
Vol.50 No.02
By Jacquelyn Cobb
Drugs & Targets

FDA approves Welireg for advanced renal cell carcinoma

January 05, 2024
Vol.50 No.01
Drugs & Targets

FDA approves Padcev + Keytruda for locally advanced or metastatic urothelial cancer

January 05, 2024
Vol.50 No.01
FDA, Friends identify next steps for dose optimization, pragmatic trials, academic-led studies for drug approvals

FDA, Friends identify next steps for dose optimization, pragmatic trials, academic-led studies for drug approvals

December 15, 2023
Vol.49 No.46
By Matthew Bin Han Ong
Drugs & Targets

FDA approves Welireg for advanced renal cell carcinoma

December 15, 2023
Vol.49 No.46

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