FDA Review posts product approval summaries for the week ending 1/7/2022.
A Texas federal court rules against FDA in a Freedom of Information Act lawsuit by a group seeking data and information on the Pfizer/BioNTech Covid-1...
FDA amends the emergency use authorization for the Moderna Covid-19 vaccine to shorten the time between the completion of primary vaccination with the...
AbbVie files a supplemental NDA for Rinvoq (upadacitinib,15 mg once daily) for treating certain adults with active non-radiographic axial spondyloarth...
A PhRMA-funded study finds that more than half of every $1 spent on brand medicines went to payers, middlemen, providers, and other stakeholders in 20...
FDA clears a Becton, Dickinson 510(k) for the BD Kiestra IdentifA system, which is designed to automate preparation of microbiology bacterial identifi...
CDER embraces industrys use of physiologically based pharmacokinetic modeling as an alternative bioequivalence (BE) approach after approving a Perrigo...