FDA publishes a guidance to help sponsors develop drugs and biologics to treat chronic hepatitis B virus.
FDA publishes for comment a draft of revisions to the International Council for Harmonization M7 guideline on calculating compound-specific acceptable...
Three drug companies comment on an FDA draft guidance on the labeling content and format of immunogenicity information in human prescription therapeut...
Federal Register notice: FDA announces a 4/19 virtual public meeting entitled Medical Device User Fee Amendments to discuss proposed recommendations f...
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...