The Food and Drug Administration's approval in 2023 of lecanemab—a novel Alzheimer's therapy shown in clinical trials to modestly slow disease progression—was met with enthusiasm by many in ...

In a recent study, researchers found adverse events were rare and manageable among clinic patients with very mild or mild Alzheimer's disease who received lecanemab infusions. The Food and Drug ...

The Food and Drug Administration is drawing up plans that ... as well as in other markets like medical products. In the past, FDA inspectors had been trained to do multiple kinds of inspections ...

May 14 (Reuters) - The U.S. Food and Drug Administration has approved ... FDA's accelerated approval of Emrelis was based on a mid-stage trial of 84 patients, where the drug showed an overall ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...

The U.S. Food and Drug Administration announced Friday it has granted three new color additive petitions to expand the available colors from natural sources that can be safely used in food ...

In fact, the Food and Drug Administration 20 years ago raised questions about whether it truly works, as well as its potential to cause cancer. But the agency never acted on its own concerns.

according to an announcement from the Food and Drug Administration. The agency says the approvals are part of its plan to phase out petroleum-based dyes but it has not proposed any official ...

Kennedy, Jr., announced that he has directed the Food and Drug Administration (FDA ... Mifepristone is described by leading medical authorities as among the safest medications being used today, based ...

About 48 million people in the U.S.(about one in six) fall prey to a foodborne pathogen every year, according to the U.S. Food and Drug Administration ... or have to seek medical care.

The move is a significant shift away from the current approach of universally green-lighting the shots, and comes just two days before the Food and Drug Administration’s (FDA) independent ...