Feb 9 (Reuters) - Regenxbio said on Monday the U.S. Food and Drug Administration had declined to approve its gene therapy for ...

Feb 9 (Reuters) - The U.S. Food and Drug Administration said a television advertisement for Novo Nordisk's weight-loss pill ...

Feb 9 (Reuters) - Regenxbio said on Monday the U.S. Food and Drug Administration had declined to approve its drug for Hunter ...

By Stine Jacobsen and Maggie Fick COPENHAGEN, Feb 9 (Reuters) - Novo Nordisk sued Hims and Hers Health on Monday over patent ...

The FDA has removed R/R PCNSL from a Limitations of Use section on the CAR-T product’s label based on positive findings from ...

The FDA has outlined numerous concerns about the sale and use of unapproved GLP-1 drugs for weight loss.  “FDA is aware that ...

“The policy is too broad and could be abused in ways that mislead or confuse consumers, many of whom will assume that ‘no ...

A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten ...

One of the largest autism trials of leucovorin (Wellcovorin), a drug used to treat cerebral folate deficiency, was retracted ...

In addition, FDA must be radically transparent about its outbreak investigations by releasing the name of the consumer-facing ...

After facing a delayed decision deadline and a clinical hold, Regenxbio’s Hunter syndrome gene therapy has been rejected by ...

The FDA underwent significant changes during the first year of the second Trump administration, directly affecting business ...