The Trump administration is officially conducting an investigation into the safety of the abortion pill mifepristone, the Wall Street Journal reports. Health experts worry that the process may be ...

The US Food and Drug Administration (FDA) has proposed guidance on the types of scientifically valid prior knowledge sponsors should consider when developing certain gene therapies (GT). The agency ...

Cumulative dataset of all U.S. Food and Drug Administration (FDA) marketing authorizations for artificial-intelligence and machine-learning (AI/ML)-enabled medical devices recorded between September ...

“How do they do that?” is a reasonable response to certain things we see in nature. Pythons and snakes like them can eat prey as big as they are, sometimes even bigger, and digest their massive single ...

Single adequate and well-controlled trial plus confirmatory evidence became the default approval paradigm, formalizing a trend already common for first-in-class oncology and rare-disease products.

See more of our trusted coverage when you search. Prefer Newsweek on Google to see more of our trusted coverage when you search. U.S. Food and Drug Administration (FDA) Commissioner Dr. Marty Makary ...

The Food and Drug Administration has issued a Class I recall correction for certain Boston Scientific ACCOLADE pacemakers and cardiac resynchronization therapy pacemakers after identifying a ...

The Accolade pacemaker system. [Image from Boston Scientific] The FDA today issued a new Class I recall correction that expands the scope of affected Boston Scientific (NYSE: BSX) pacemakers and ...

The Food and Drug Administration said Boston Scientific will upgrade certain pacemakers to a new software as part of a recall. Boston Scientific issued a letter to affected customers recommending all ...