The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition, the company said on Friday, sending its shares tumbling 30% in early trading.

HOUSTON, Texas (KTRK) -- The Food and Drug Administration is currently reviewing a first-of-its-kind, twice-yearly injectable medication that experts say could revolutionize HIV prevention. The ...

Here’s what food and drug regulation might look like under the Trump administration Leaders of the FDA have published a list of new priorities for the agency.

“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed foods are often targeted toward children and said the agency has focused on ...

U.S. Food and Drug Administration Approves Nuvation Bio’s IBTROZI™ (taletrectinib), a Next-Generation Oral Treatment for Advanced ROS1-Positive Non-Small Cell Lung Cancer ...

Biotech companies developing drugs for hard-to-treat diseases and other ailments are being forced to push back clinical trials and drug testing in the wake of mass layoffs at the Food and Drug ...

The Food and Drug Administration has gone all in on AI since Martin Makary, M.D., took over the agency, most recently demonstrated by the coronation of ...

Under President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr., the reach of the Food and Drug Administration is being scaled back by executive fiat. Reporting ...

According to a recall report from the Food and Drug Administration, Church & Dwight Co. issued a recall for medical swabs sold under the Zicam and Orajel brand names after it learned they could be ...

The U.S. Food and Drug Administration said Tuesday it will expand its use of unannounced inspections at foreign manufacturing facilities.

Bi, 69, served as the chief of the China Food and Drug Administration from 2015 to 2018, when he introduced regulatory overhauls that spurred innovation in China’s pharmaceutical sector.

Recent restructuring efforts at the Food and Drug Administration may have been well-intentioned, but they risk undermining the very innovation and domestic capacity the president seeks to promote.