The US Food and Drug Administration (FDA) has declined to approve Lantheus Holdings’ diagnostic imaging kit for certain types of cancer tumors. The decision was made due to unresolved manufacturing-related conditions at a third-party facility.
The FDA did not identify any concerns regarding the data submitted by Lantheus in support of the application, nor did it identify any issues related to the safety or efficacy of the imaging kit, known as LNTH-2501.
Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.
