Saudi Food and Drug Authority

CEL-SCI to Begin U.S. Registration Study for Multikine in Summer 2026, Pursues Saudi Partnership

Jun 12, 2026

CEL-SCI plans to start patient enrollment in summer 2026 for a 212-patient U.S. registration study of its cancer immunotherapy Multikine, with the goal of seeking early accelerated approval. The company is also advancing a strategic partnership with Saudi Amarox to commercialize Multikine in Saudi Arabia, where it has submitted a Breakthrough Medicine Designation application. These initiatives build on Phase 3 data showing Multikine improved 5-year survival in head and neck cancer patients from 45% to 73%.

ImmunityBio Says Saudi FDA Encouraged rBCG Filing and ANKTIVA Expansion Talks

May 17, 2026

ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.

CEL-SCI plans summer 2026 enrollment in Multikine head and neck cancer registration study

May 14, 2026

CEL-SCI said it expects to begin summer 2026 enrollment in a 212-patient U.S. confirmatory registration study of Multikine in head and neck cancer. The company also said it submitted a Breakthrough Medicine Designation application in Saudi Arabia and reported quarterly net loss of $5.5 million.

ImmunityBio launches ANKTIVA in Saudi Arabia after accelerated lung cancer approval

Apr 25, 2026

ImmunityBio has commercially launched ANKTIVA in Saudi Arabia for approved bladder and metastatic non-small cell lung cancer indications. The launch follows accelerated approval in lung cancer and extends the drug’s commercial rollout in MENA.

Quoin Pharmaceuticals Secures Key Regulatory Designations and Reports Clinical Progress

Mar 26, 2026

Quoin Pharmaceuticals has secured Orphan Drug Designations for QRX003 in the U.S. and Europe for Netherton Syndrome, while advancing regulatory pathways in Japan and Saudi Arabia. The company reported clinical progress including expansion of pediatric studies and potential for a Priority Review Voucher worth up to $200 million.

ImmunityBio Resubmits ANKTIVA Bladder Cancer Application to FDA, Advances Saudi Approvals

Mar 09, 2026

ImmunityBio resubmitted its supplemental BLA to the FDA for ANKTIVA in papillary bladder cancer after providing additional data. The company also received encouragement from Saudi regulators to submit a recombinant BCG application and expand ANKTIVA approvals.

ImmunityBio Reports 700% Revenue Growth, Expands Anktiva to 33 Countries and Lung Cancer

Feb 24, 2026

ImmunityBio announced $113 million in net product revenue for Anktiva in 2025, a 700% year-over-year increase, while expanding regulatory authorization to 33 countries and securing first approval for lung cancer treatment in Saudi Arabia.

ImmunityBio Gains EU Approval for Anktiva Bladder Cancer Therapy, Expands to Saudi Arabia

Feb 21, 2026

ImmunityBio receives conditional EU marketing authorization for Anktiva combination therapy in bladder cancer, covering 33 countries, while establishing distribution partnerships in Saudi Arabia for bladder and lung cancer patients.

ImmunityBio Secures EU Authorization for ANKTIVA, Expands to 33 Countries

Feb 19, 2026

The European Commission granted conditional marketing authorization for ANKTIVA in combination with BCG for BCG-unresponsive non-muscle invasive bladder cancer, expanding the therapy's availability to 33 countries across four regulatory jurisdictions.

ImmunityBio Shares Surge 42% After EU Grants Conditional Approval for Anktiva Bladder Cancer Therapy

Feb 18, 2026

ImmunityBio's stock jumped 41.9% following the European Commission's conditional marketing authorization for Anktiva combined with BCG to treat BCG-unresponsive non-muscle invasive bladder cancer across 33 European countries.