The U.S. Food and Drug Administration has approved expanded use of Amgen's drug, Uplizna, to help reduce the risk of flares ...

The U.S. Food and Drug Administration said on Tuesday it had named Scott Steele as acting director of its Center for ...

Susan Aaron was an active 74-year-old retiree with Alzheimer’s who was told she might experience extreme fatigue and terrible ...

Public health leaders looked to UNC-Chapel Hill virologist Ralph Baric to end the pandemic. Their critics blamed it on him.

Senate President Pro Tempore Kelly Anthon introduced Senate Bill 1211 on Monday. The Senate State Affairs voted to send it to ...

Visby Medical Women’s Sexual Health Test can be taken by those with or without symptoms,and delivers results in about 30 ...

There are lots of interesting companies that make Bedford their home. Below is a quick recap of what’s happening around town ...

The FDA has granted accelerated approval to Novartis’ Vanrafia for adults with primary immunoglobulin A nephropathy (IgAN).

Amgen said the Food and Drug Administration approved Uplizna for Immunoglobulin G4-related disease, the second approved indication. The biotechnology company said Thursday the FDA granted breakthrough ...

“As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our [Biologics License Application] is ready for approval,” Novavax said in a ...

Amgen (NASDAQ: NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has granted an expanded label approval ...

The agency is sitting on a decision to grant full approval for Novavax’s shot, days after top vaccine regulator pushed out.