FDA clears a United Imaging 510(k) for its first interventional X-ray system uAngio Aviva.
FDAs Oncology Center of Excellence launches Project Interface, a new initiative aimed at deepening engagement with cancer patients, advocacy groups, a...
U.S. health officials order a temporary pause on the use of the chikungunya vaccine Ixchiq in individuals aged 60 and older following reports of serio...
FDA grants Beam Therapeutics a Regenerative Medicine Advanced Therapy designation for BEAM-302, a gene therapy designed to correct a disease-causing m...
New CBER director Vinay Prasad defends his past criticisms of vaccines and says he is not anti-vax and promises that the Center will strive to always ...
FDA grants MeiraGTx Holdings a regenerative medicine advanced therapy designation for gene therapy AAV-GAD and its use for treating Parkinsons disease...
FDA prepares to begin negotiation sessions in September to reauthorize the Prescription Drug User Fee Act, which expires 9/2027.
FDA commissioner Marty Makary says discussions are continuing with Novavax on its BLA to convert a 2022 emergency use authorization to a full approval...
