The U.S. Food and Drug Administration has approved Arcutis Biotherapeutics' Zoryve (roflumilast) topical foam 0.3% for the ...

The FDA approved two natural food dyes and expanded approval of a third on Friday in line with HHS’ goal to eliminate ...

Treatment options for children with hemophilia A have expanded with the FDA approval of Bayer's Jivi antihemophilic factor (recombinant), PEGylated-aucl for the treatment of pediatric patients between ...

The wand developed by Teal Health allows patients to self-collect a vaginal sample and mail it to a lab for testing.

The FDA approved three natural food dyes this week amid its transition away from petroleum-based dyes in the food supply. The colors "will expand the palette of available colors from natural ...

The FDA Wednesday approved nipocalimab-aahu (Imaavy; Johnson & Johnson) for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients 12 years or older who are anti ...

AVMAPKI FAKZYNJA CO-PACK is the first and only FDA-approved medicine for this disease. This indication is approved under accelerated approval based on the tumor response rate and duration of response.

Instead, FDA Commissioner Marty Makary told reporters last month that the agency will be accelerating the review and approval of some new natural color additives. Here are the latest "natural ...

Tepylute, a ready-to-dilute thiotepa formulation, approved for breast and ovarian cancers, potentially improving preparation efficiency. Here is a recap of every FDA approval announced by the ...

In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. GSK had expected to secure an FDA ...