The European Medicines Agency’s Human Medicines Committee (CHMP) on Friday issued a negative opinion for Omeros Corp.’s OMER ...

A first-of-its-kind drug may slow the progression of Huntington's disease, a rare, fatal, neurodegenerative disorder.

The FDA has approved a new sunscreen ingredient called bemotrizinol for use in the United States, marking the first time in ...

The US Food and Drug Administration (FDA) on Thursday issued draft guidance that would replace the accelerated approval portion of its broader guidance covering its various expedited pathways to ...

An FDA advisory committee voted unanimously on June 18 to recommend that a messenger RNA-based influenza vaccine at the center of a recent change of heart by the FDA be approved for older adults.In ...

ST. LOUIS — A newly FDA-approved procedure allows patients to regrow their own knee cartilage using autologous cell implantation. The treatment, known as MACI (Matrix Autologous Chondrocyte ...

The U.S. Food and Drug Administration has approved another over-the-counter intranasal naloxone product, Rextovy (naloxone ...

After more than two decades of delay, American consumers are finally getting access to a sunscreen ingredient that has long ...

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...

Researchers urge inclusion of negative studies on drug labels ...

The FDA has told Amgen that it is proposing to withdraw the approval of the rare disease drug Tavneos. The U.S. regulator is questioning the effectiveness and safety of Tavneos. It also says that its ...