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

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 ...

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

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

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

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

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 ...

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

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 ...

Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studiesGranted Fast ...

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

Since semaglutide was approved by the FDA for weight loss under the brand name Wegovy in 2021, GLP-1 medications—originally ...