With a fresh FDA endorsement for its drug plozasiran, California-based Arrowhead Pharmaceuticals has successfully broken ...

The agency calls out the "inherent risks" that consumers face when purchasing unapproved or misbranded drugsNEED TO KNOWThe U ...

FDA issued 18 warning letters to websites selling unapproved or misbranded botulinum toxin products. Officials say the ...

Image by Tung Lam from Pixabay 6, 2025 - The U.S. Food and Drug Administration has issued 18 warning letters to owners of ...

In the past, biosimilar makers have been able to invalidate some of those patents through a sped-up process called “inter ...

Poherdy is the first FDA-approved interchangeable biosimilar to Perjeta for HER2-positive breast cancer, potentially expanding access and reducing costs. Approved for use in combination with ...

Zydus won final FDA approval to market a generic version of Vumerity for adults with relapsing forms of MS and active SPMS.

Botox should only be given by licensed medical professionals using FDA-approved products, the agency warned THURSDAY, Nov. 6, ...

The FDA just recommended tighter restrictions and the potential drug classification of kratom products containing a specific extract called 7-OH. Currently, these unregulated, non-FDA-approved ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

The first botulinum toxin product, onabotulinumtoxinA, was approved by the FDA in 1989. Since then, FDA has approved several ...

The Food and Drug Administration is removing black box warnings from hormone replacement therapy products and approving new ...