FDA grants breakthrough therapy designation for UCBs Cimzia in some pregnant women with antiphospholipid syndrome.
FDA warns Stephen Fallon of Wilton Manors, FL, about bioresearch violations in his role as clinical investigator of a trial of an investigational prod...
FDA cautions Fenwal International about CGMP deviations at its Maricao, Puerto Rico, facility that manufactures blood pack units.
FDA solicits public comment on a proposed study to learn from healthcare providers their understanding of barriers to higher patient enrollment in pre...
FDA cites Travere Therapeutics over promotional materials for Filspari (sparsentan) because they contain misleading claims about the drugs ability to ...
FDA accepts for priority review an Intellia Therapeutics BLA for lonvo-z, an in vivo CRISPR-based therapy for treating hereditary angioedema.
FDA acknowledges that Bristol Myers Squibbs accelerated approval of Krazati (adagrasib) in combination with cetuximab for adults with previously treat...
HHS names CDER acting director Michael Davis and CBER acting director Karim Mikhail as permanent directors of their respective offices.
