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ImmunityBio Partners with Biopharma and Cigalah Healthcare to Launch ANKTIVA® in Saudi Arabia for Bladder and Lung Cancer Patients
Businesswire· 2026-02-20 13:30
Core Insights - ImmunityBio, Inc. has announced a partnership with Biopharma and Cigalah to launch ANKTIVA® in Saudi Arabia and the broader MENA region [1] Company Overview - ImmunityBio, Inc. is a commercial-stage immunotherapy company focused on developing innovative treatments [1] - Biopharma and Cigalah are recognized as two of the largest healthcare commercial and distribution companies in the Middle East [1] Partnership Details - The agreement involves Biopharma and Cigalah supporting the commercialization and distribution of ANKTIVA® [1]
ImmunityBio Advances Regulatory Discussions with FDA on Potential Resubmission Path for ANKTIVA® in BCG-Unresponsive Papillary Bladder Cancer
Businesswire· 2026-01-20 09:00
Core Viewpoint - ImmunityBio, Inc. has engaged in a Type B End-of-Phase meeting with the U.S. FDA regarding its supplemental Biologics License Application for ANKTIVA® in treating BCG-unresponsive non-muscle invasive bladder cancer [1] Group 1 - The meeting focused on the clinical status of ANKTIVA® (nogapendekin alfa inbakicept) combined with Bacillus Calmette-Guérin (BCG) [1]
Saudi FDA Grants Accelerated Approval to ImmunityBio's ANKTIVA® In Combination with Checkpoint Inhibitors for Metastatic Non-Small Cell Lung Cancer
Businesswire· 2026-01-14 13:30
Core Viewpoint - ImmunityBio, Inc. has received accelerated approval from the Saudi Food and Drug Authority for ANKTIVA® in combination with immune checkpoint inhibitors for treating adult patients with metastatic non-small cell lung cancer who have progressed after standard therapy [1] Group 1 - The approval of ANKTIVA® represents a significant milestone as it is the first approval of this treatment in the region [1] - The indication is specifically for adult patients with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following standard-of-care therapy [1]
Saudi FDA Grants Accelerated Approval to ImmunityBio's ANKTIVA® for Non-Muscle Invasive Bladder Cancer with Carcinoma In-Situ
Businesswire· 2026-01-14 13:30
Core Viewpoint - ImmunityBio, Inc. has received approval from the Saudi Food and Drug Authority for ANKTIVA® in combination with Bacillus Calmette-Guérin (BCG) for treating adult patients with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ [1] Regulatory Approval - The approval by the SFDA expands the existing approvals for ANKTIVA® in the United States [1]
ImmunityBio Receives Conditional Marketing Authorization Recommendation from the European Medicines Agency for ANKTIVA® with BCG for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ—A First in Europe
Businesswire· 2025-12-12 11:10
Core Viewpoint - ImmunityBio has received a recommendation from the European Medicines Agency for conditional marketing authorization of ANKTIVA® in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer [1] Company Summary - ImmunityBio is a leading immunotherapy company focused on innovative treatments for cancer [1] Industry Summary - The recommendation from the European Medicines Agency is expected to facilitate early access to new medicines addressing significant unmet medical needs in cancer treatment [1]