FDA approves a Treos Bio IND for PolyPEPI 1018 to allow a Phase 1 study to proceed with the investigational precision cancer vaccine for patients with...
FDA approves a Perrigo ANDA for a generic version of Allergans Estrace Cream (estradiol vaginal cream, USP, 0.01%).
CBER issues a revised a Standard Operating Policy and Procedure on Formal Dispute Resolution Process.
CDER director Janet Woodcock says a central focus for the Center in 2018 is modernizing the new drug review program.
Indias Semler Research Center sues FDA over an inspection report that it says incorrectly alleged the company engaged in data manipulation in clinical...
FDA approves a Shire application for the technology transfer of Cinryzes (C1 esterase inhibitor [human]) drug product manufacturing process to its Vie...
FDA looks at 17 new safety signals for drugs identified in the third quarter of 2017.
Iroko Pharmaceuticals asks FDA to dismiss an Apotex ANDA for generic Zorvolex because the generic does not have the same active ingredient as the refe...