Continue to Site

Drug Discovery and Development

FDA approves removal of boxed warning from label for osteoporosis drug Tymlos

By |

RadiusRadius Health (NASDAQ:RDUS) has announced that the FDA has approved removing a boxed warning from the label of Tymlos, an osteoporosis drug.

The warning had described a risk of osteosarcoma, a type of bone cancer.

The agency reviewed long-term post-marketing data related to the drug and the broader class of related parathyroid hormone (PTH) drugs.

“This is an important update to the Tymlos label,” said Dr. Bruce Mitlak, the chief medical officer of Radius, in a statement. “Achieving this result was made possible by FDA analysis of a significant amount of data that had been generated over many years.”

The FDA first approved Tymlos (abaloparatide) as an osteoporosis treatment in individuals with a high fracture risk.

RDUS shares ticked up 2% on December 24 to $7.14.

 

Filed Under: clinical trials, Drug Discovery
Tagged With: , , , ,
 

About The Author

Brian Buntz

The pharma and biotech editor of WTWH Media, Brian is a veteran journalist with more than 15 years of experience covering an array of life science topics, including clinical trials, drug discovery and development and medical devices. Before coming to WTWH, he served as content director focused on connected devices at Informa. In addition, Brian covered the medical device sector for 10 years at UBM. At Qmed, he overhauled the brand’s news coverage and helped to grow the site’s traffic volume dramatically. He had previously held managing editor roles on two of the company’s medical device technology publications. Connect with him on LinkedIn or email at [email protected]

Tell Us What You Think!

Related Articles Read More >

Search Drug Discovery & Development