The Refusal to File letter comes despite the FDA’s prior encouragement to submit a supplemental biologics license application ...

ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced that the Company received a Refusal to ...

The FDA issued an RTF for sBLA of nogapendekin alfa plus BCG for BCG-unresponsive NMIBC papillary disease, following prior ...

ImmunityBio's ANKTIVA sBLA for papillary bladder cancer was rejected by the FDA despite prior support, prompting the company ...

ANKTIVA was approved by the FDA in 2024 with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without papillary tumors. For more ...

ImmunityBio's sBLA for Anktiva was unexpectedly rejected by the FDA, contradicting prior positive feedback and approval for a ...

TAR-200 demonstrated a high disease-free survival and bladder preservation rates in BCG-unresponsive, high-risk ...

The CR rate was consistent across subgroups including men and women, patients with and without papillary disease, and ...

With an FDA review underway, Johnson & Johnson is aiming to “fundamentally change” how bladder cancer is treated. | With an ...

The RTF letter was unexpected, especially considering the positive feedback and unanimous encouragement ImmunityBio received ...

Suggested remit: To appraise the clinical and cost effectiveness of Sasanlimab with BCG within its marketing authorisation for treating bladder cancer.