The US Food and Drug Administration has granted orphan drug designation (ODD) to Tempest Therapeutics' oral, selective ...
What Happened: The Food and Drug Administration (FDA) released new guidance regarding the registration and listing of ...
Snake oil, it turns out, motivated the founding of the FDA. The term “snake oil” arose out of a controversy from the late ...
The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
The Food and Drug Administration approved Eli Lilly’s weight-loss drug Zepbound on Dec. 27 to treat sleep apnea, a common but ...
The four new guidance documents are designed to help industry and other interest holders understand and comply with FDA ...