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...
PhRMA and Lilly say a proposed FDA study on proprietary names is not likely to provide useful information.
FDA cleares a Biolase 510(k) for the EdgePro system for cleaning and disinfection during root canal procedures performed by endodontists.
FDA approves an Otsuka America Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) for treating schizophrenia in pediatric pat...
Medtronic recalls its Synergy Cranial and StealthStation S7 Cranial software due to potential inaccuracies caused by the devices Biopsy Depth Gauge Cy...