Gilead Sciences files an NDA for a once-daily single tablet regimen containing bictegravir (50 mg), an investigational integrase strand transfer inhib...
FDA accepts for review a Synergy Pharmaceuticals supplemental NDA for Trulance (plecanatide) for treating adults with irritable bowel syndrome with co...
Eli Lilly says it is planning a BLA before year-end after reporting positive results from three Phase 3 studies of galcanezumab, an investigational tr...
Public Citizen senior advisor Sidney Wolfe criticizes FDA for originally approving Endo Pharmaceuticals controversial pain drug Opana ER (oxymorphone ...
FDA seeks comments on an information collection reinstatement for Electronic Products OMB Control Number 09100025.
Federal Register notice: FDA announces a 6/26 Science Board meeting.
FDA Review posts product approval summaries for the week ending 6/16/2017.
FDA Review posts the latest Federal Register notices for the week ending 6/9/2017.