FDA releases the form FDA-483 issued following an inspection at the Clarence, NY-based Athenex Pharma Solutions outsourcing facility.
Three stakeholders recommend broadening the impact of an FDA draft guidance on computer software assurance.
AdvaMed says FDA should withdraw its draft guidance on LASIK patient labeling recommendations because the group has numerous concerns about the docume...
FDA issues Roche Molecular Systems an emergency use authorization for its cobas MPXV monkeypox test.
FDA clears a Xironetic 510(k) for its IntraOpVSP augmented reality (AR) visualization software for use in complex surgeries.
Protalix BioTherapeutics and Chiesi Global Rare Diseases resubmit a BLA for PRX102 (pegunigalsidase alfa) for treating adult patients with Fabry disea...
Roche says results from two Phase 3 studies evaluating Alzheimers therapy gantenerumab were not statistically significant in slowing clinical decline....
Federal Register notice: FDA makes available a final guidance entitled Referencing the Definition of a Device in the Federal Food, Drug, and Cosmetic ...
