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

Bottlenecks and high regulatory costs at the Food and Drugs Authority (FDA) is discouraging small- and medium-sized enterprises (SMEs) from obtaining the necessary sanitary permits and product ...

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.

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 ...

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...

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.