The U.S. Food and Drug Administration has approved a prefilled syringe version of Netherlands-based Argenx SE's blockbuster ...

The Food and Drug Administration has cleared diabetes-management firm DexCom's new continuous glucose monitoring (CGM) system ...

The US Food and Drug Administration announced Thursday that it will be phasing out a requirement that monoclonal antibodies ...

Biocon Biologics has gained approval from the US Food and Drug Administration (FDA) for the intravenous use of Jobevne ...

“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 ...

Dosing starts at once every two months and is based on the FDA-cleared INNOVANCE Antithrombin companion diagnostic test (Siemens). Fixed dosing of Qfitlia is not approved due to excessive clotting ...

The Food and Drug Administration (FDA) announced Thursday it plans to phase out animal testing requirements for biological ...

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 ...

TUESDAY, April 1, 2025 (HealthDay News) -- The U.S. Food and Drug Administration granted marketing authorization for the first home-based, nonprescription diagnostic test for chlamydia, gonorrhea ...

Proprio’s Paradigm AI guidance platform displays real-time progress during surgery, replacing X-ray and CT scans.

According to the FDA, in 2020, nearly one in five high school students and almost one in 20 middle school students used e-cigarettes. REUTERS The agency over the years has approved only 34 ...