CBER says the number of HCT/P inspections was down in FY 2019.
FDA approves a Sanofi BLA for Dupixent (dupilumab) for children aged six to 11 years with moderate-to-severe atopic dermatitis whose disease is not ad...
Cell2in asks FDA to update guidances to identify real-time glutathione monitoring as an acceptable measure of potency for use in submitting a BLA for ...
FDA says it will not object to some design or manufacturing modifications for devices approved through a PMA or HDE during the Covid-19 public health ...
FDA releases its latest batch of Warning Letters that includes Altaire Pharmaceuticals and Samchundang Pharm.
FDA clears a Smart Medical Systems 510(k) for the G-Eye Colonoscope.
FDA releases a draft ICU guideline of permitted daily exposure to three solvents.