
SHINE Technologies’ Ilumira has received Centralized Marketing Authorization in Europe, the company announced today.
“For years, our customers have asked for a reliable partner that can deliver both the diagnostic and therapeutic side of nuclear medicine,” SHINE CEO Michael Rossi said in a statement. “EMA approval opens the door for SHINE’s radioisotope Lu-177 to be used in developing radioligand therapies at scale and ultimately support the expanded reach of nuclear medicine to patients.”
According to a release, this regulatory clearance is what’s required to sell Lu-177 into the European Union.
As previously reported, Ilumira is solely intended for radiolabeling of carrier molecules and is not for direct patient use.
