By Bhanvi Satija and Puyaan Singh (Reuters) - The U.S. Food and Drug Administration on Tuesday declined full approval for ...

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

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

The sNDA was submitted to support full approval of OCA for this indication based on data from the COBALT trial, as well as real-world evidence.

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

The agency’s ability to hire and retain skilled employees may be in jeopardy given Trump ally Robert F. Kennedy Jr.’s ...

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

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

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

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

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

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