Japan relies almost entirely on China for the APIs of β-lactam antibiotics. These drugs are essential for treating infectious diseases…
REGULATORY
Orphan Tag Granted to Opdivo, Leniolisib, and 6 More APIs
Japan’s health ministry on May 23 granted orphan drug designation for eight APIs including Ono Pharmaceutical’s cancer drug Opdivo (nivolumab) for a new indication and Pharming Technologies’ PI3Kδ inhibitor leniolisib. Opdivo was designated for the proposed indication of unresectable, advanced/relapsed…
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REGULATORY
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