The U.S. Food and Drug Administration has declined to approve Corcept Therapeutics' drug for the treatment of a rare hormonal ...

Vanda Pharmaceuticals said on Tuesday its drug for the prevention of motion-induced vomiting was approved by the U.S. health ...

The Food and Drug Administration has approved Novo Nordisk’s once-daily Wegovy pill, the first oral GLP-1 medicine for ...

The FDA has approved the first GLP-1 pill for weight loss and it's expected in pharmacies in the coming weeks. Dr. Holly ...

Outlook Therapeutics said on Wednesday the U.S. health regulator has declined to approve its drug for a type of eye disease, ...

The FDA appointed George Tidmarsh, MD, PhD, to be the nation's top drug official in July. The Center for Drug Evaluation and ...

The FDA has rejected Sanofi's application seeking approval of tolebrutinib to treat certain forms of MS in its present form.

The US saw several new and expanded FDA indications this year. The top 5 most-read FDA approvals on AJMC.com included 4 novel ...

The FDA has approved Deseyne contact lenses with extended depth of focus for the correction of presbyopia, according to a ...

The FDA has issued a complete response letter for an oral selective glucocorticoid receptor antagonist under investigation ...

The U.S. Food and Drug Administration has approved Jascayd (nerandomilast) tablets for the treatment of progressive pulmonary ...

A memo from Dr. Vinay Prasad​, the head of the FDA's Center for Biologics Evaluation and Research, may signal an effort to to ...