ImmunityBio Requests an Urgent Meeting With FDA to Address the Change in the Agency's Unambiguous Guidance on Jan 2025 to Submit

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  Posted by Two Blokes May 5 - Filed in Stock - 1 view
  
  CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced that the Company received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for the supplemental biologics license application (sBLA) for use of ANKTIVA plus Bacillus Calmette-Guerin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for the indication of papillary disease. This RTF letter was received despite reaching unanimous.