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.
FDA clears the ReddyPort elbow device used in non-invasive ventilation.
FDA releases the form FDA-483 issued following an inspection at the Little Rock, AR-based SCA Pharmaceuticals outsourcing facility.
Mercks Keytruda with concurrent chemoradiotherapy meets the progression-free survival primary endpoint in an interim analysis of the KEYSTONE A-18 cer...
