The FDA issued draft guidance Jan. 21 proposing the use of minimal residual disease and complete response as primary endpoints to support accelerated approval of drugs for multiple myeloma. The draft ...
FDA warns canned tuna tied to a year-old recall was mistakenly sent to Safeway, Albertsons, Vons and Pavilions stores across ...
On Wednesday, the US Food and Drug Administration initiated what’s known as a Request for Information asking the public for input on how often the presence of grains like rye and barley are disclosed ...
FDA approves first brain stimulation device for home depression treatment. Flow Neuroscience's FL-100 headset uses electrical ...
The FDA clears triage tool by Aidoc that detects 14 acute conditions from CT scans to improve emergency care workflows.
On Wednesday, radiology AI company Aidoc announced the FDA has cleared a tool that can triage 14 critical findings in a ...
We are grateful for the collaborative feedback from FDA on the Gemini program, which provides us a clear and expedient path forward for seeking approval of Gemini as a treatment for AKI,” said, James ...
The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals to develop two agentic AI assistants for ...
The U.S. Food and Drug Administration (FDA) has accepted a new drug application for gedatolisib for the treatment of patients ...
The FDA approved external trigeminal nerve stimulation (TNS) in 2019 as the first non-drug device for treating ADHD, ...
The FDA has granted breakthrough therapy designation (BTD) to soficabtagene geleucel (sofi-cel; WU-CART-007) for the ...
For years, the federal government advised Americans to limit red meat and foods high in saturated fats. However, new federal ...