FDA says that Medtronic has released the first round of software updates to address some cybersecurity vulnerabilities identified in wireless telemetr...
FDA approves Aimmune Therapeutics Palforzia [peanut (Arachis hypogaea) allergen powder-dnfp] for treating peanut allergies.
FDA requests that all bacitracin for injection manufacturers voluntarily withdraw their product from the market because the benefits no longer outweig...
FDA approves a Teva Pharmaceuticals an autoinjector device for its Ajovy (fremanezumab-vfrm) injection for preventing migraine in adults.
FDA grants Aprea Therapeutics a breakthrough therapy designation for APR-246 in combination with azacitidine for treating myelodysplastic syndromes.
Federal Register notice: FDA released a final guidance on Chemistry, Manufacturing, and Control information for gene therapy INDs.
Federal Register notice: FDA posts a final guidance on human gene therapy development for hemophilia.
Public Citizen sues FDA in DC federal court to obtain the scientific reviews used to grant accelerated approval for Janssen Pharmaceuticals bladder ca...