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, ...

Robert F. Kennedy Jr., one of President-elect Donald J. Trump’s advisers on health, is taking aim at the agency’s oversight ...

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

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

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

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

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

BioNTech said that it is acquiring the Chinese drugmaker Biotheus for $800 million to bolster its cancer strategy. The two ...

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

The products are part of the agency's ongoing public health alert concerning cinnamon with elevated lead levels ...

1,300 cases (amounting to about 46,800 pounds) of Kirkland Signature Unsalted Sweet Cream Butter and 900 cases (amounting to ...