Memos posted on FDAs Web site from CBER director Vinay Prasad suggest the agency is raising the bar on future Covid-19 vaccination approvals.
FDA accepts for review an Achieve Life Sciences NDA for cytisinicline, an investigational treatment for helping those seeking to quit smoking.
Reuters reports that drug manufacturers are turning to artificial intelligence to reduce animal testing and cut costs and time in drug development.
FDA approves two new denosumab biosimilars from Shanghai Henlius Biotech and Organon for treating osteoporosis and cancer-related bone conditions.
Merck says its oral PCSK9 inhibitor met all primary and secondary endpoints in the CORALreef Lipids Phase 3 trial.
FDA releases the form FDA-483 with four observations from an inspection at the Las Vegas, NV-based AnazaoHealth compounding facility.
FDA policy and regulatory expert Steven Grossman warns that the agencys current trajectory risks undermining its effectiveness by prioritizing politic...
FDA warns Jackson, WI-based Wisconsin Pharmacal about CGMP violations in its production of finished drugs.
