The Food and Drug Administration is reconsidering its decision not to approve a drug that an Omaha mom says is saving her son's life. In May, the FDA denied approval of the drug, elamipretide, but ...

BioMarin downgraded to Hold amid rising competition, pipeline concerns, and ambitious growth targets, despite solid Q1 2025 ...

Tens of millions of people in the United States struggle with obstructive sleep apnea, a condition that occurs when the throat muscles narrow during sleep, leading to temporary pauses in breathing ...

Vertex Pharmaceuticals, under the leadership of CEO Reshma Kewalramani, was named in the “Impact Awards” category, which spotlights five standout companies making meaningful advancements in their ...

A meeting Wednesday at the Food and Drug Administration about fluoride supplements became, at one point, a contentious ...

U.S. Food and Drug Administration employees told CNN that Elsa — the AI model that’s supposed to help speed up approvals of pharmaceuticals and medical devices — isn’t working great. Instead, it cites ...

Roche has halted some international shipments of the gene therapy Elevidys, used to treat Duchenne muscular dystrophy, Bloomberg reported July 22. The decision comes in the wake of a similar move by ...

DAP Health has received the new twice-yearly injection for HIV prevention. Here's what you need to know if you're interested ...

Hallucinations are a known problem with generative AI models—and Elsa is no different, according to Jeremy Walsh, the head of ...

Health officials are finding medetomidine is now emerging as a dangerous adulterant in the illegal drug supply and often mixed with other illicit drugs.

The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment ...