FDA says that after the partial government shutdown ends it will extend or reopen the comment period on an 11/20/2018 Federal Register notice entitled...
FDA lifts a partial clinical hold against MacroGenics and its Phase 1 monotherapy and combination studies of cancer drug MGD009, a B7-H3 CD3 bispecifi...
Furloughed FDA employees are expected to return to work early next week under a 1/25 tentative agreement reached between President Trump and Congress ...
FDA approves a CorMatrix Cardiovascular early feasibility study IDE to evaluate the safety and feasibility of the Cor Tricuspid ECM cardiac valve for ...
FDA releases two draft guidances to help companies develop REMS assessment plans concurrently with the plans themselves.
Based on recent discussions with FDA, Bristol-Myers Squibb withdraws a supplemental BLA for an indication in metastatic first-line non-small cell lung...
FDA clears a Hologic de novo submission for the Aptima Mycoplasma genitalium Assay, a new test to aid in the diagnosis of the sexually-transmitted inf...
King & Spalding attorneys explain the three latest FDA documents issued for the software precertification program.