Enzychem Lifesciences, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to EC-18 for the treatment of Acute Radiation Syndrome (ARS).
Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced the U.S. Food and Drug Administration (FDA) awarded Orphan Drug Designation(ODD) to Shire`s gene therapy candidate SHP654 (also designated as BAX 888), an investigational factor VIII (FVIII) gene therapy for the treatment of hemophilia A. The regulatory agency also granted Shire investigational new drug (IND) status for SHP654.
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