Invivyd Aligns with U.S. FDA on Rapid Pathway to Full Approval (BLA) of Vaccine Alternative Monoclonal Antibody VYD2311 to Protect American Adults and Adolescents from COVID-19 ...

An unusual about-face that played out at the FDA over the last week illustrated the power of the “Make America Healthy Again” ...

Europe, Ukraine hope for chilly Putin summit ▪ The Hill interview: Newsom defends redistricting fight ▪ Progressives take center stage in mayoral contests ▪ Israel steps up ...

The U.S. Food and Drug Administration has approved Insmed's oral drug for a type of lung disease, the company said on Tuesday ...

FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers ...

Generative AI technology has tremendous potential for the healthcare industry, but we shouldn’t expect too much – especially if we’re the FDA.

Eastman Kodak Co. reported a second-quarter loss and a year-over-year drop in sales, as the company leans on a Rochester ...

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Some oncologists and researchers have raised concerns about delays in the completion of confirmatory trials, but FDA now has new tools to push them ahead.

This data was produced from a multi-center study that enrolled 125 patients. The data demonstrates that VIVO was over 94% accurate, assisted physicians in determining workflow when used pre-procedure, ...

The U.S. Food and Drug Administration said on Friday it has approved Boehringer Ingelheim's drug for patients with a type of ...

U.S. health officials have told more than a half-dozen of the nation’s top medical organizations that they will no longer help establish vaccination recommendations.