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Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization”
FreeTrials & Tribulations

Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization”

January 27, 2023
Vol.49 No.04
By Mark J. Ratain and Garth W. Strohbehn
In Brief

Grassley, Durbin, Tillis, Coons introduce legislation to strengthen coordination between Patent Office, FDA

January 27, 2023
Vol.49 No.04
Drugs & Targets

FDA approves Keytruda as adjuvant treatment for NSCLC

January 27, 2023
Vol.49 No.04
Drugs & Targets

FDA approves Brukinsa for CLL or SLL

January 27, 2023
Vol.49 No.04
ODAC Confidential: The seven deadly sins sponsors commit again and again at FDA presentations
Guest Editorial

ODAC Confidential: The seven deadly sins sponsors commit again and again at FDA presentations

January 20, 2023
Vol.49 No.03
By Mikkael A. Sekeres
Drugs & Targets

Tukysa + trastuzumab receives FDA accelerated approval for previously treated metastatic CRC

January 20, 2023
Vol.49 No.03
Drugs & Targets

FDA publishes draft guidance on optimizing dosage for oncology drugs

January 20, 2023
Vol.49 No.03
Drugs & Targets

FDA grants priority review to glofitamab for R/R LBCL

January 13, 2023
Vol.49 No.02
Drugs & Targets

FDA grants accelerated approval to Lunsumio for R/R follicular lymphoma

January 06, 2023
Vol.49 No.01
Drugs & Targets

FDA approves first gene therapy for high-risk, non-muscle-invasive bladder cancer

January 06, 2023
Vol.49 No.01

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