A House committee staff report blasts Emergent Biosolutions for hiding its Covid-19 vaccine manufacturing problems from FDA and HHS.
FDA approves a new indication for Eli Lillys Olumiant (baricitinib) for treating Covid-19 in hospitalized adults requiring supplemental oxygen, non-in...
CBER increases from 13 to 17 the number of guidances it expects to develop in 2022.
Former FDA Digital Health Center of Excellence director Bakul Patel says the agency needs additional congressional authorities to fully implement its ...
Federal Register notice: FDA determines that Pfizers Glucotrol (glipizide) tablets, 2.5 mg, were not withdrawn from sale due to safety or effectivenes...
Federal Register notice: FDA makes available a draft guidance entitled Benefit-risk Considerations for Product Quality Assessments.
Eisai files a rolling BLA submission under the accelerated approval pathway for its investigational anti-amyloid beta protofibril antibody lecanemab (...
FDA revokes a Bio-Rad Laboratories Emergency Use Authorization (EUA) and a Bio- Applied DNA Sciences EUA for their no-longer-distributed Covid-19 test...