FDA rejects an emergency use authorization request filed by University of Minnesota Medical School infectious disease physician David Boulware and oth...
FDA Review posts the Federal Register notices for the week ending 5/13/2022.
FDA Review posts product approval summaries for the week ending 5/13/2022.
The journal Nature examines the problems with FDAs accelerated approval program and potential reforms to reduce any gaming by the pharmaceutical indus...
Federal Register notice: FDA issues a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tes...
BridgeBio Pharma sells for $110 million its priority review voucher that was awarded last year when FDA approved Nulibry (fosdenopterin) for an ultra-...
FDA sends UCB a complete response letter on its BLA for psoriasis-treating bimekizumab, citing deficiencies from a recent preapproval inspection as th...