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CDER Wants Access to Manufacturing Operations
FDA Places Partial Clinical Hold on CTI’s BioPharma’s Pacritinib
FDA Extends PDUFA Date of Sarepta’s DMD Candidate
BioCryst’s Avoralstat Misses Primary Endpoints
MHRA Issues Warnings for Epilepsy Drug During Pregnancy
FDA Grants Orphan Drug Designation to Atara Candidate
Epizyme Scores Win as Tazemetostat Granted Orphan Status