Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S.

Shares of uniQure plummeted more than 40% in premarket trading Monday after the company confirmed the FDA has rejected its current data package for AMT-130, a highly anticipated gene therapy for ...

Not long after Novo Nordisk received an untitled letter from the FDA disputing certain elements of the first TV spot for its ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

The FDA approved Dupixent as the first treatment for allergic fungal rhinosinusitis in adults and children over six years old ...

The regimen’s clearance in early multiple myeloma was the third approval under the agency’s controversial “national priority” voucher program and issued only 55 days after the review began.

FDA leadership is emphasizing one adequate, well-controlled trial plus confirmatory evidence as a default pathway, with ...