ImmunityBio Requests an Urgent Meeting With FDA to Address the Change in the Agency’s Unambiguous Guidance on Jan 2025 to Submit a sBLA for NMIBC BCG Unresponsive Papillary Disease, Following an Inconsistent Refusal to File Letter on May 2, 2025

May 5, 2025 | Press Releases

CULVER CITY, Calif., May 5, 2025 – 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...

Unmatched Long-Term Bladder Preservation for 36 Months in over 80 percent of Responders with ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC CIS and Papillary Disease Alone – Best in Disease and Best in Class with 5 Year Follow-Up

Apr 28, 2025 | Press Releases

CIS with or without Papillary: Oral presentation from QUILT-3.032 study showed 71% complete response rate (N=100), with duration of response ranging up to more than 53 months, in BCG-unresponsive NMIBC CIS with or without papillary disease Probability of duration of...