A cancer patient enrolled in a clinical trial today might wait months before regulators ever see the safety data generated by ...
By Ahmed Aboulenein WASHINGTON, April 28 (Reuters) - The U.S. Food and Drug Administration launched a pilot program on Monday ...
The FDA today announced a new initiative to allow its reviewers to access information from clinical trials in real time, with ...
FDA-regulator access to near real-time safety and endpoint streams is intended to enable earlier signal detection and more ...
On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major barrier to the use of real-world evidence (RWE) in medical device ...
The FDA has moved to pull Tavneos (avacopan) from the U.S. market, alleging that manipulated clinical trial data propped up ...
The Food and Drug Administration is asking Eli Lilly to gather more safety data on its new weight loss pill, Foundayo, including whether it could be linked to liver and heart problems, according to th ...