The Company is scheduled to present at 9:20am Eastern Time the same day via webcast. A live webcast of the event can be ...

The FDA said it proposed significant changes to simplify biosimilarity studies and reduce what it described as unnecessary ...

President Donald Trump’s top health advisers announced a push to cut health costs by bringing more cutting-edge generic drugs ...

The FDA has revealed a set of measures designed to increase the availability of biosimilars in the U.S. and in turn reduce ...

Senators cite study showing 22 times higher serious side effects from chemical abortion drugs than FDA labels indicate, ...

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

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

The Food and Drug Administration announced Wednesday that it would ease regulatory roadblocks for low-cost copycat versions ...

Generic versions of biologic drugs could hit the market without human trials and allow the market forces to bring down costs, ...

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

The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

The U.S. Food and Drug Administration is preparing to accelerate approvals for biosimilars, or generic versions of complex ...