The Saudi Food and Drug Authority (SFDA) has approved the registration of Iqirvo (Elafibranor) for the treatment of adults with primary biliary cholangitis (PBC) who have had an inadequate response to ursodeoxycholic acid (UDCA) or are unable to tolerate it.
The CEO of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, recently conducted official visits to several pharmaceutical facilities and research centers in the United States. The visits aimed to review the latest advancements in the global pharmaceutical industry and leverage international expertise to advance scientific research and innovation in the pharmaceutical field.
The CEO of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, participated in the Drug Information Association (DIA) 2026 Global Annual Meeting, held from June 14–18 in Philadelphia, Pennsylvania. The event brought together heads of regulatory authorities, global decision-makers, and leading experts in pharmaceuticals, biotechnology, and regulatory sciences from across the world.
The Saudi Food and Drug Authority (SFDA) has granted orphan drug designation to Gomekli (mirdametinib), developed by SpringWorks Therapeutics, to treat adults and children with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) that cannot be fully removed by surgery.
Registration is Subjected to Full Scientific Evaluation
The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to ZENBEXUS (Iberdomide), developed by Bristol-Myers Squibb, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy, to be used in combination with daratumumab and dexamethasone
Registration Subject to Full Scientific Evaluation
The Saudi Food and Drug Authority (SFDA) has granted Novo Nordisk Breakthrough designation to (FREHEMGO), which is indicated as a long-term routine prophylaxis of bleeding episodes in all age groups patients with hemophilia A with or without FVIII inhibitors.
In a landmark move to safeguard the health of millions, the Saudi Food and Drug Authority (SFDA) and the Organisation of Islamic Cooperation (OIC) have forged a strategic partnership to launch a comprehensive global campaign titled “Safe Medicines, Safe Hajj Journey.” This initiative represents a unified effort across 57 nations to prioritize medication safety and public health during the world’s largest annual gathering.
The Saudi Food and Drug Authority (SFDA) has approved the registration of Etcamah (camizestrant) for the treatment of adult patients with locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with an ESR1 gene mutation that emerges during first-line hormonal therapy, in combination with CDK4/6 inhibitors.
