The U.S. Food and Drug Administration said on Friday it has launched a new pilot program to speed up the review process for ...

The agency expanded use of an old drug as a treatment for some people with autism. The endorsement sent some customers ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

Artificial intelligence is poised to dramatically reshape the process of developing and approving new medicines, according to ...

Kaiser Health News interviewed Robert Califf, MD, former FDA commissioner, concerning his thoughts on the drug approval process and the current presidential administration’s outlook on quickening the ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

US President Donald Trump recently made comments linking the painkiller acetaminophen, also known as Tylenol, to autism, for ...

FDA approves generic Mifepristone from company Evita Solutions as Sen. Josh Hawley blasts agency for regulatory failure and ...

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...