Valneva must immediately cease U.S. shipments and sales of Ixchiq, a vaccine for chikungunya virus. The FDA recently lifted a ...

As Department of Health and Human Services (HHS) and FDA leadership continue to look for ways to boost transparency and ...

The FDA Adverse Event Reporting System, which Commissioner Marty Makary called “clunky,” previously published updates on a ...

According to the vaccine's maker, Valneva, the FDA based its decision to suspend the shot on four new serious adverse events ...

The U.S. Food and Drug Administration has started "real-time reporting of adverse event data," according to an annoucement ...

The FDA said it has begun publishing reports of adverse events concerning drugs on a daily basis, instead of quarterly, as it ...

The FDA has started reporting real-time data about adverse events through the FDA Adverse Event Reporting System, improving ...

Seltorexant is safe and more effective than placebo and a standard insomnia med for sleep initiation and maintenance, a new ...

Shares of French drugmaker Valneva slumped more than 20% on Monday after the U.S. Food and Drug Administration suspended the ...

The U.S. Food and Drug Administration said that it has begun the daily publication of adverse event reports related to drugs ...

In patients with active lupus nephritis, iscalimab shows efficacy in reducing proteinuria and is generally well tolerated.

From Oct. 7, 2022, to Oct. 6, 2023, these facilities reported 610 adverse health events, including 222 that resulted in serious injury and 16 that resulted in a patient's death.