Capricor Therapeutics is expected to release data from the phase 3 HOPE-3 trial in Q3'25, thus presenting a potential path ...

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

Dr. Makary joined NewsNation to discuss his first 100 days FDA Commissioner: 'People forget that the ‘F’ in FDA stands for food' FDA focused on fighting childhood obesity and diabetes As part of the ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.