Federal Register notice: FDA seeks comments on an information collection revision on positron emission tomography drug GMPs.
FDA releases the October-December 2021 safety signal report with 40 listings from the FDA Adverse Events Reporting System.
Medtronic says a clinical trial showed that patients who were prescribed anti-hypertensive medications and treated with its Symplicity Spyral Renal De...
FDA approves a BioXcel Therapeutics NDA for Igalmi (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophreni...
FDA officials say that a decision will likely be made in June on whether a new Covid-19 booster composition is needed by November in time for any wint...
A new FDA whitepaper outlines the agencys plans to advance a framework to objectively rate pharmaceutical manufacturing sites Quality Management Matur...
FDA grants priority review for Sanofi and Regenerons sBLA for a new Dupixent indication.
FDA gives commercial licensure approval to a second Novartis gene therapy manufacturing facility, this one in Durham, NC.