The Saudi Food and Drug Authority (SFDA) prevented the entry of more than 301 tons of non-compliant food products into the Kingdom of Saudi Arabia during the second quarter of 2026, following laboratory testing that confirmed microbial contamination posing food poisoning risks to consumers.
The Saudi Food and Drug Authority (SFDA) has granted orphan drug designation to Gritgen Therapeutics Co., Ltd. for its “GS1168 Injection” intended for the treatment of Phenylketonuria (PKU). This designation reflects the SFDA’s continued commitment to supporting pharmaceutical innovation and improving patient access to advanced therapies for rare diseases.
Understanding Phenylketonuria (PKU)
The Saudi Food and Drug Authority (SFDA) has announced the suspension of the registration for the drug (Avacopan), commercially known as Tavneos. This decision is part of the authority’s ongoing regulatory procedures and post-marketing surveillance to monitor the safety and efficacy of pharmaceutical products, thereby enhancing patient protection and upholding the highest standards of drug safety.
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
