Officials with the FDA have approved the first generic robenacoxib tablets for the control of postoperative pain and ...

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 ...

Amneal Pharmaceuticals has announced the FDA approval of its prednisolone acetate ophthalmic suspension, a 1% sterile topical anti-inflammatory treatment intended for steroid-responsive ocular ...

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

The FDA just recommended tighter restrictions and the potential drug classification of kratom products containing a specific extract called 7-OH. Currently, these unregulated, non-FDA-approved ...

The Bethlehem-based maker of at-home diagnostic tests said it submitted two separate applications to the FDA at the end of ...

Federal health officials are warning Americans to avoid sunscreens marketed in whipped, mousse and foam because they aren't approved as effective methods for applying the product. The Food and Drug ...