The US FDA has published more than 200 complete response letters sent as replies to drug and biological product applications.

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 FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...

The FDA has accepted the New Drug Application for ET-600, an oral solution formulation of desmopressin, for the treatment of central diabetes insipidus.

The FDA is expected to decide on treatments for bronchiectasis, chronic immune thrombocytopenia, fibromyalgia, Friedreich ataxia, and recurrent respiratory papillomatosis.

The inspection concluded with a Form 483 containing several observations. Capricor said it has submitted its responses to the FDA, none of which required material changes to the cGMP process or ...

Capricor Therapeutics' rating was downgraded amid FDA inspection risks, regulatory uncertainty, and potential delays in approval for deramiocel. Read more on CAPR stock here.

The U.S. Food and Drug Administration has declined to approve an injectable version of Johnson & Johnson's drug Rybrevant for a type of lung cancer, the drugmaker said on Monday.

The Muscular Dystrophy Association trusts the decision of the FDA, which weighs the risks and benefits of the drug.