The unapproved antidepressant is sold in gas stations and online under various names, leading to addiction and severe side ...

As part of its attempt to force food companies to voluntarily stop using artificial food dyes, the FDA has approved three dyes that it says come from ...

The FDA extended aficamten's review by three months for REMS safety program finalization, causing Cytokinetics' stock to drop ...

The latest canine otitis externa medication is the only FDA-approved, 1-dose, in-clinic treatment for Pseudomonas aeruginosa ...

FDA Commissioner Martin Makary sounded the alarm on tianeptine, also known as "gas station heroin," and its growing adverse ...

The FDA is warning the public about a drug rising in popularity commonly referred to as as "gas station heroin." ...

The Food and Drug Administration has approved a new device called the Teal Wand, which its creator describes as an "at-home ...

Alkermes has a huge opportunity to expand its label to include pediatric patients with Schizophrenia and bipolar I disorder.

While Johnson & Johnson isn't the first to secure FDA approval for an FcRn-blocking antibody in myasthenia gravis, the New ...

Conflicting QSSD definitions from two federal agencies mean that CMS’ administrative authority on drug pricing and payment is ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

The FDA is delaying implementation of a rule that would require food companies to print nutritional information on the front labels of their products. The ...