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...
A just-released, scathing (XXX INSERT XXX)23-page Form FDA-483 cites 10 GMP deficiencies at Sun Pharmaceutical Industries Halol manufacturing facility...