FDA says it is working with Pfizer to monitor the potential for drug shortages after a 7/19 tornado severely damaged Pfizers large sterile injectables...
Federal Register notice: FDA sends to OMB an information collection revision entitled Current Good Manufacturing Practice for Blood and Blood Componen...
Federal Register notice: FDA announces that seven information collections have been approved by OMB.
FDA grants Astria Therapeutics fast track status for STAR-0215 for treating hereditary angioedema.
FDA approves a Daiichi Sankyo NDA for Vanflyta (quizartinib) in certain patients with newly diagnosed acute myeloid leukemia.
All Democrats on the House Energy and Commerce Committee sponsor legislation to reauthorize the Pandemic and All-Hazards Preparedness Act and give FDA...
FDA says healthcare providers, laboratories, and facilities should immediately stop using the Quidel Triage Cardiac Panel due to inaccurate results th...
Former CBER Office of Tissues and Advanced Therapies director Wilson Bryan joins regulatory consulting firm Greenleaf Health as executive vice presid...
