The strength and credibility of the FDA relies on maintaining a clear line between evidence-based, scientific rigor and ...

Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.

In a major shift, the US Food and Drug Administration is relaxing a long-standing drug approval requirement for common diseases.

FDA’s focus on playing a direct role in lowering drug prices may provide opportunities for some pharmaceutical companies to seek a regulatory advantage. But it also places enormous pressure on ...

The move comes months after the Trump administration touted leucovorin as a potential therapy for a broader group of patients with autism symptoms.

Months after promising help for “hundreds of thousands of kids,” the FDA approved the decades-old medicine for a disease ...

The FDA has faced an extraordinary convergence of political, scientific, legal, and operational pressures over the last year.

Biologics are complex medications produced through biological processes or from living organisms such as proteins and genes. Biosimilars are what they sound like — similar to, but not the same as, an ...

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...