The drug, Ocaliva, will continue to be available in the U.S. under the accelerated approval status, the company said. Under ...

The U.S. Food and Drug Administration has approved Journey Medical's Emrosi (minocycline hydrochloride) for the treatment of ...

Caris Life Sciences has obtained an FDA approval for its MI Cancer Seek tumor profiling assay, unlocking its use as a ...

In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...

With the FDA's acceptance of Urogen's NDA and issuance of an 06/13/2025 PDUFA the clock is now ticking for FDA approval of ...

Jaguar Health announced that its product, cofelemer delayed-release tablets (Canalevia-CA1; Jaguar Health), received approved ...

The Food and Drug Administration (FDA) recently gave Apple the green light to use software that may help million of people ...

That approval pathway is for devices that are similar to products that are already approved for market. GE HealthCare said the system would offer new capabilities in clinical imaging and neuroscience ...

Psilocybin-assisted therapy could potentially benefit up to 5.6 million Americans with major depressive disorder or treatment ...

Below, I'll break down what's going on at Viking and explain how the company may emerge as a competitive force in the weight ...

Last month, a second phase 3 blow for Marinus Pharmaceuticals prompted the Pennsylvania-based drugmaker to turn an eye toward ...

Understanding the right dose of Ozempic for you can feel a bit confusing, especially if you’re just getting started. While ...