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...
Pharmaceutical Research and Manufacturers of America tells FDA its draft guidance on reporting the amount of listed drugs and biological products woul...
The Council for Responsible Nutrition says FDA failed to respond to its legal inquiry on the agencys policy shift involving marketing dietary suppleme...
The Justice Department says a federal grand jury indictment charges a North Carolina doctor with multiple offenses related to Medicare billing for bal...
FDA clears the VySpine VySpan posterior cervical thoracic system.