FDA denies an Escher Fund for Autism petition asking it to withdraw approval of Amag Pharmaceuticals Makena for use during pregnancy.
Federal Register notice: FDA announces a 3/7 Oncologic Drugs Advisory Committee meeting to review Amgen supplemental BLA for Blincyto.
Federal Register notice: FDA makes available a guidance entitled Regulatory Classification of Pharmaceutical Co-Crystals.
Stakeholders react to an FDA discussion paper associated with a guidance on patient-focused drug development.
Federal Register notice: FDA classifies the non-absorbable, hemostatic gauze for temporary internal use into Class 2 (special controls).
Two Fried, Frank attorneys say that recent court decisions questioning the wisdom of whistleblower enforcement under the False Claims Act raise the po...
FDA expands the time the Trevo clot retrieval device can be used in stroke patients.
FDA authorizes marketing of the Banyan Brain Trauma Indicator, a blood test that predicts when concussion patients do or do not have intracranial lesi...