The FDA granted Orphan Drug Designation to tamibarotene for the treatment of MDS in February 2022. The EMA’s CHMP recommendation is based on positive results from the multicohort, open-label... The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use issued... The European Medicines Agency validated a type II variation for the extension of the indication for lisocabtagene maraleucel ... The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use recommended the conditional approval ...