FDA Review posts the Federal Register notices for the week ending 3/18/2022.
FDA Review posts product approval summaries for the week ending 3/18/2022.
PhRMA tells Congress that proposed reforms to the accelerated approval program are not needed and that it is concerned with any FDA-related policy pro...
Moderna submits an Emergency Use Authorization amendment to permit an additional Covid-19 vaccine booster (fourth dose) in adults 18 years of age and ...
New data from the pivotal Phase 3 KEYNOTE-091 trial finds that adjuvant treatment with Mercks Keytruda significantly improved disease-free survival, r...
Federal Register notice: FDA revokes an Emergency Use Authorization issued to Abbott Diagnostics Scarborough for the BinaxNOW Covid-19 Ag Card 2 Home ...
Federal Register notice: FDA seeks comments on an information collection extension entitled Evaluation of the Program for Enhanced Review Transparency...