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 ...
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 ...
However, there’s one major catch — psychedelics are still awaiting FDA approval for medical use. Psilocybin, the active ...
Psilocybin-assisted therapy could potentially benefit up to 5.6 million Americans with major depressive disorder or treatment ...
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 ...
Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studiesGranted Fast ...
The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, ...
Since semaglutide was approved by the FDA for weight loss under the brand name Wegovy in 2021, GLP-1 medications—originally ...
GLP-1 receptor agonists, originally developed for managing type 2 diabetes, have rapidly emerged as highly effective ...
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...