Nearly 300,000 bottles of the drug, named Cinacalcet, were recalled and given a Class II recall risk level by the FDA.

The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...

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Costco customers with dairy allergies may need to check their fridge because 80,000 pounds of the retailer's butter was ...

The U.S. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its ...

FDA Chief Robert Califf reflects on potential changes as Trump's re-election looms, expressing disappointment and ...

GE HealthCare (Nasdaq:GEHC) announced today that it received FDA 510(k) clearance for its Signa Magnus MRI scanner.

Hims & Hers (HIMS) is launching a new GLP-1 tracker in its efforts to fight back against the FDA’s decision to end compounded ...

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 ...

The agency has placed a partial hold on the phase 2a PORTOLA trial evaluating the selective immunoproteasome inhibitor ...

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