By Bhanvi Satija and Puyaan Singh (Reuters) - The U.S. Food and Drug Administration on Tuesday declined full approval for ...

While personally “disappointed” about the election’s outcome, current FDA Commissioner Robert Califf, M.D., has laid out the ...

BIRMINGHAM, Ala. (WBRC) - The U.S. Food and Drug Administration (FDA) does not allow Red No. 3 to be used in cosmetics, but ...

Adaptimmune Therapeutics is prepping for another FDA submission after 42% of patients with sarcoma responded to the company's ...

FDA Chief Robert Califf reflects on potential changes as Trump's re-election looms, expressing disappointment and ...

Robert F. Kennedy Jr., one of President-elect Donald Trump’s advisers on health, is taking aim at the agency’s oversight on ...

The agency’s ability to hire and retain skilled employees may be in jeopardy given Trump ally Robert F. Kennedy Jr.’s ...

The sNDA was submitted to support full approval of OCA for this indication based on data from the COBALT trial, as well as real-world evidence.

The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and ...

The products are part of the agency's ongoing public health alert concerning cinnamon with elevated lead levels ...

Nearly 300,000 bottles of the drug, named Cinacalcet, were recalled and given a Class II recall risk level by the FDA.

The FDA has added a new warning to drugs including Ozempic and Wegovy, cautioning that patients taking the drugs may be at a ...