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

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

the second approved indication. The biotechnology company said Thursday the FDA granted breakthrough therapy designation. In 2020, the FDA approved Uplizna for AQP4-IgG+ Neuromyelitis Optica ...

“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 ...

But with FDA action, it would be the third vaccine against COVID-19 to receive full FDA approval. Full approval would make the vaccine available beyond an emergency declaration and could provide ...

Continued FDA approval depends on Phase 3 ALIGN study results in 2026. Feel unsure about the market’s next move? Copy trade alerts from Matt Maley—a Wall Street veteran who consistently finds ...

The FDA is reviewing the BLA for mepolizumab ... Arcutis Biotherapeutics is seeking to expand the approval of roflumilast foam to include the treatment of adults and adolescents 12 years and ...

AstraZeneca's treatment for adults with muscle-invasive bladder cancer was approved in the U.S. The U.K. drugmaker said Monday that Imfinzi was approved by the Food and Drug Administration after ...