The FDA has approved updates to Radius Health Inc's (NASDAQ:RDUS) Tymlos label, including removing the boxed warning regarding the risk of osteosarcoma, a type of cancer.
- The removal of the boxed warning comes after a thorough regulatory review of long-term post-marketing data in Tymlos and the parathyroid hormone (PTH) class of drugs.
- Related content: Benzinga's Full FDA Calendar.
- Additional labeling revisions include updates to the Warnings and Precautions section about the risk of osteosarcoma.
- "We remain focused on exploring additional label adjustment opportunities for TYMLOS and, in that regard, maintain an ongoing dialogue with the FDA around additional data," said Chhaya Shah, Senior Vice President, who leads the clinical and regulatory activities for abaloparatide.
- Tymlos (abaloparatide) injection was approved by the FDA for postmenopausal women with osteoporosis at high risk for fracture.
- Price Action: RDUS shares are down 1.15% at $6.92 during the market session on the last check Thursday.
