The U.S. Food and Drug Administration has declined to approve an additional indication for Zynyz, a cancer therapy developed by Incyte (INCY) and MacroGenics (MGNX), due to issues found at a third-party manufacturing site run by Novo Nordisk’s (NVO) Catalent unit.

Vanda Pharmaceuticals’ seven-year ambition to score a coveted label expansion for sleep drug Hetlioz has taken an unusual turn, with the FDA acquiescing to a formal hearing on the matter. | The company has been pressing the FDA to hold a formal hearing on its proposed jet lag label expansion for Hetlioz since it was first snubbed way back in 2019.

The FDA proposes front-of-package "Nutrition Info boxes" to highlight saturated fat, sodium, and added sugars. The initiative aims to combat chronic diseases and promote healthier food choices. Large companies must comply within three years, smaller ones ...

Evidence suggests commercial health plans are more likely to delay specialty drug coverage decisions in response to FDA

Please provide your email address to receive an email when new articles are posted on . Safety labels will now explain risks associated with long-term use. Data from a pair of postmarketing requirements are driving these changes. Applicants have 30 days to ...

By Michael Erman and Puyaan Singh March 5 (Reuters) - A senior FDA official called UniQure's experimental treatment for Huntington's disease a "failed product" in a conference call with media on Thursday,