The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track ...

A more detailed review of data by the FDA showed that GLP-1 drugs do not increase the risk of suicidal ideation or behavior.

As required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), on December 29, 2025, the U.S. Food and Drug ...

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...

FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...

An extension was required to provide time to review additional data requested by the FDA to clarify sparsentan’s clinical benefit.

Marbán indicated, "We expect to report top line data within the next few weeks." The company plans to submit HOPE-3 results as a formal complete response to the FDA's complete response letter, aiming ...

More than half a dozen major drugmakers are participating in the Trump administration's speedier review program for new medicines, yet other leading pharmaceutical companies are hesitating over what ...

Federal health regulators say popular weight loss drugs like Wegovy and Zepbound do not increase the risk of suicidal thoughts, and they have asked drugmakers to remove those warnings from medication ...

Internal FDA reviews examined in the JAMA study show that the agency repeatedly confirmed that mifepristone is safe. One ...