Food and Drug Administration Commissioner Marty Makary said in a recent interview he has no plans to change policies ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...

The review notes that the current legal limit for drinking water in the bloc is 1.5 milligrams of fluoride per liter, which ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

But it’s unclear if the evidence provided to support continued use of fluoridated supplements will matter. The FDA said in ...

The FDA's 'Elsa' AI, intended to speed up drug approvals, is reportedly fabricating studies, part of a wider trend of ...

Nootropics are substances that enhance cognitive performance through various mechanisms, including cholinergic, glutamatergic, and dopaminergic pathways. They include prescription medications, natural ...

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

On Monday morning, the FDA hosted a 10-person expert panel on the use during pregnancy of SSRIs, which include medications ...

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.