The Prescription Drug User Fee Act date refers to the deadline set by the FDA for reviewing a NDA or Biologics License Application.

Novo Nordisk addresses safety concerns surrounding compounded versions of its weight-loss and diabetes drugs, including ...

Compounded versions of semaglutide, the active ingredient in approved diabetes and obesity drugs ... 100 hospitalizations ...

During October, the FDA approved drugs to treat diseases including breast cancer, lung cancer, leukemia and gastric cancer. In October, several cancer therapies received approval from the Food and ...

The U.S. Food and Drug Administration has approved Journey Medical's drug for the treatment of a long-term skin condition ...

Share on Pinterest A drug that has already gained FDA approval for the treatment of ulcerative colitis is also effective in the treatment of Crohn’s, new data suggest. Brothers91/Getty Images ...

"The FDA's approval of Lumryz was not arbitrary or capricious," U.S. District Judge Amit P. Mehta wrote in a memorandum ...

Last week, the FDA updated its database of drugs in shortage ... branded versions of tirzepatide-based drugs – Mounjaro, for diabetes, and Zepbound, approved at the end of 2023 for weight ...

Mirikizumab is a drug currently approved by the Food and Drug Administration (FDA) for the treatment of ulcerative colitis. Pharmaceutical company Eli Lilly recently released findings of two ...