FDA denies a Metacel petition asking the agency to require flavoring tests for generic forms of the companys Ozobax.
FDA publishes a draft International Council for Harmonization M15 guidance on model-informed drug development principles.
FDA grants MeMed a breakthrough device designation for its MeMed Severity test, intended for use in determining risk assessments in patients suspected...
Confirmatory data evaluating Eli Lillys pirtobrutinib in adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma meets its prim...
FDA clears Pentax Medical 510(k)s for new endoscope models for colonoscopy and upper GI use.
Federal Register notice: FDA makes available a guidance entitled Standardized Format for Electronic Submission of NDA and BLA Content for the Planning...
FDA updates a Baxter recall (device correction) of its MiniCap Extended Life PD Transfer Sets used in hemodialysis.
FDA accepts for review a supplemental NDA for Nucala (mepolizumab) and its use as an add-on maintenance treatment for patients with chronic obstructiv...
