FDA medical reviewers ask members of the Cellular, Tissue, and Gene Therapies Advisory Committee for their opinion on difficult questions about a Spar...
Reps. Brooks and Trott introduce a bill creating a public-private partnership to protect Americans sensitive healthcare information from cyberattacks....
In its fourth major decision since May for drug products aimed at non-small lung cancer (NSCLC), FDA accepts for priority review a Boehringer Ingelhei...
Federal Register correction: FDA corrects a final order entitled Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascu...
FDA approves a Respicardia PMA for the Remed System as a treatment option for patients who have been diagnosed with moderate to severe central sleep a...
FDA clears a Roche 510(k) for the Cobas C-diff Nucleic acid test for detecting the toxin B gene of toxigenic Clostridium difficile.
FDA accepts an Amgen supplemental BLA for Prolia (denosumab) for treating patients with glucocorticoid-induced osteoporosis.
FDA grants AstraZeneca a breakthrough therapy designation for Tagrisso (osimertinib) for the first-line treatment of patients with metastatic epiderma...