FDA Places Geron’s IND For GRNOPC1 On Hold
Geron has announced that its IND (Investigational New Drug application) for GRNOPC1 has been placed on clinical hold by FDA, pending the agency’s review of new nonclinical animal
Swedish Orphan Biovitrum (Sobi) has received a complete response letter from the US Food and Drug Administration (FDA) regarding its biologics licence application for nanoencapsulated sirolimus plus pegadricase (NASP), an investigational therapy intended for adults with uncontrolled gout.