The U.S. Food and Drug Administration has placed a clinical hold on Intellia Therapeutics' two late-stage trials testing an ...

The U.S. Food and Drug Administration has approved Lynkuet, a new medication that does not contain hormones to treat hot ...

Federal regulators are trying to make it easier to develop cheaper alternatives to powerful drugs that many Americans depend ...

Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drug Administration (FDA) Commissioner Marty Makary ...

Elinzanetant belongs to a new class of drugs designed to target what is believed to be a key mechanism responsible for ...

The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex ...

The Trump administration is proposing changes to Food and Drug Administration guidelines that would make it less expensive ...

If approved, it would be the first major new drug treatment for Parkinson’s in half a century. Richard Mailman, a University ...

The agency announced moves to cut regulatory obstacles for the makers of biosimilar drugs, which are akin to generics and may ...

The Food and Drug Administration is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to ...

Texas Attorney General Ken Paxton alleged Johnson & Johnson deceptively marketed the drug as safe for pregnant Texans.

Health and Human Services Secretary Robert F. Kennedy Jr., and Food and Drug Administration (FDA) Commissioner Marty Makary ...