Japan relies almost entirely on China for the APIs of β-lactam antibiotics. These drugs are essential for treating infectious diseases…
REGULATORY
Japan Panel Says No to Full Approval of HeartSheet, Clears Breyanzi’s Broader Label
A Japanese health ministry panel on July 19 gave its thumbs-down to the granting of full traditional approval for Terumo’s HeartSheet, autologous skeletal myoblast sheets for heart failure, due to insufficient efficacy data. The Pharmaceutical Affairs and Food Sanitation Council’s…
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