Keyword: Food and Drug Administration (FDA)

All 12 members of an FDA advisory committee voted to recommend the approval of teprotumumab for a rare, autoimmune eye disease.

The FDA has cleared its first fully disposable duodenoscope, following years of reports of infections being transmitted between patients.

Can an unexpected Sarepta win be good news for Biogen?

Kite hopes to win approval for KTE-X19 in mantle cell lymphoma on the strength of midphase results linking it to a 67% complete response rate.

After Novartis’ near $10 billion buyout of The Medicines Company, many thought cardiovascular therapies were hot again.

FDA staff took the action in response to cases of early growth plate closure in children on the retinoic acid receptor gamma agonist.

The FDA has shot down Enzyvant's RVT-802, a rare immunodeficiency disease candidate, citing manufacturing concerns.

Immunomedics has had a long and troubled road in the past few years that has included losing much of its C-suite after an FDA rejection.

The dream of a comfortable, tabletop blood testing device, needing only a few drops taken from a finger and a handful of minutes, has now arrived.

Biostage’s replacement esophagus received an FDA clinical hold as the company works to field questions from the agency ahead of clinical studies.