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

Under the accelerated pathway, the FDA mandates additional trials that verify the drug's benefits. If the data from the ...

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Nearly 80,000 pounds of Costco butter was recalled because its packaging was missing the "Contains Milk statement." ...

While personally “disappointed” about the election’s outcome, current FDA Commissioner Robert Califf, M.D., has laid out the ...

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

Hims & Hers is launching a tracker of GLP-1 shortages to push back against the FDA's recent moves to end compounding copycats ...

The Sandiganbayan has acquitted former Food and Drug Administration chief Nela Charade Puno of graft, which stemmed from a ...

SmartCardia announced today that it received FDA clearance for mobile outpatient cardiac telemetry (OCT/MCT) for its ECG ...

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

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

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