Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

Johnson & Johnson eyes FDA nod to icotrokinra after phase III studies show strong skin clearance and safety in plaque ...

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, explains how the approval of Embrelis marks a pivotal moment ...

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...

The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...

A Mayo Clinic study confirmed the accuracy of a new FDA-approved blood test for early detection of Alzheimer's disease.

The US Food and Drug Administration has issued 7 warning letters to companies illegally marketing products containing 7-hydroxymitragynine (7-OH), which is found in trace amounts in kratom.

This latest approval builds on an earlier liquid formulation of generic methimazole for feline hyperthyroidism, which ...

There’s no cure for Alzheimer’s yet, but scientists may be getting closer using an unlikely tool … cancer drugs. Researchers ...

The Trump administration is inching closer to banning fluoride tablets and drops often prescribed to kids who don’t have ...

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...