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In Brief

Laleh Amiri-Kordestani named acting associate director for cardio-oncology at FDA OCE

February 03, 2023
Vol.49 No.05
Drugs & Targets

Jaypirca receives FDA accelerated approval for R/R mantle cell lymphoma

February 03, 2023
Vol.49 No.05
Drugs & Targets

Orserdu & companion diagnostic for ER+, HER2-, ESR1-mutated advanced breast cancer receive FDA approval

February 03, 2023
Vol.49 No.05
Drugs & Targets

RefleXion receives FDA clearance for SCINTIX biology-guided radiotherapy

February 03, 2023
Vol.49 No.05
Drugs & Targets

FLAG Therapeutics’s FLAG-003 receives Rare Pediatric Disease Designation for diffuse intrinsic pontine glioma

February 03, 2023
Vol.49 No.05
Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization”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Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization”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

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