The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for ...

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

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

The draft guidance, which is touted as a way to reduce the cost and time-associated burden of biosimilar development, has ...

The U.S. Food and Drug Administration (FDA) has approved two new biosimilars as reference products for Prolia (denosumab) and ...

Dr. George Tidmarsh, the FDA's top drug regulator, was placed on leave amid controversy over the drug approval process and a ...

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

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 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 FDA enlisted British drugmaker GSK to help it fast-track approval of leucovorin to treat an autism-related disorder.

AI is transforming health care, but a new study from researchers at Johns Hopkins, Georgetown, and Yale suggests we might be ...

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...