Also known as: Saudi FDA, SFDA
Novartis marks 30 years since its 1996 merger, citing advances in targeted therapy, cell therapy, gene therapy, and malaria. It also named a Levant Country President and won two clinical research awards in Saudi Arabia.
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 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 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 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 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 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 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 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.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07545330 |
Effect of Circadian Timing of a Standardized Meal on Postprandial Glucose Response in Healthy Adults |
NOT_YET_RECRUITING | NA |
| NCT07447505 |
Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting |
RECRUITING | NA |
