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...
FDA warns Memphis, TN-based Edge Biologicals about eight repeated Quality System violations in its manufacturing of in vitro diagnostics.
FDA grants Ambrx Biopharma a fast track designation for ARX517 for treating certain patients with metastatic castration-resistant prostate cancer.
NOxBOX recalls its NOxBOXi Nitric Oxide Delivery System due to a check valve misalignment in the devices manifold.
