ARTICLE | Clinical News

Holoclar regulatory update

December 22, 2014 8:00 AM UTC

EMA’s CHMP recommended conditional approval of Holoclar from Chiesi to treat moderate to severe limbal stem cell deficiency (LSCD) due to physical or chemical burns to the eye(s) in adults. EMA said Holoclar is the first medicine recommended for LSCD and the first advanced therapy medicinal product (ATMP) containing stem cells recommended for approval in the EU. Holoclar also has Orphan Drug designation. ...