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

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

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

FDA inspectors found a live spider and dead cricket in a facility that was compounding weight loss drugs for Hims & Hers.

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

Hims & Hers caused a firestorm last week when it revealed that it planned to launch a knockoff version of Novo Nordisk's new ...

Agency to restrict active pharmaceutical ingredients used in compounded GLP-1 alternatives ...

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

The Food and Drug Administration has declined to approve Regenxbio's gene therapy, RGX-121, for the treatment of Hunter syndrome, a rare and fatal neurodegenerative disease. The clinical-stage ...

The agency will no longer crack down on manufacturers that use natural dyes in foods labeled ‘No artificial colors.’ Here’s ...

The FDA has taken additional steps to support the transition from artificial petroleum-based food dyes to natural ...

The FDA requested that Novo take immediate action to address the violations, which could include ceasing all ads containing misleading claims about the pill.