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 Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative ...

The Food and Drug Administration said it will be taking steps to speed up the approval process for developing generic biological drugs, an effort aimed at increasing cheaper competition among ...

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

Sarepta’s stock plunged about 38% in after-hours trading, after it closed the regular session up 1.8%. That decline would put ...

Here in the USA, we have lived with the confidence that the medications sold over the counter, by prescription or ...

The FDA will move select drugs through the approval process in 1 to 2 months rather than the standard 10 months.

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

Life sciences group Thermo Fisher has sealed an all-cash takeover of drug trial software maker Clario in a deal that values ...

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

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