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), Dr. Hisham S. Aljadhey, conducted a series of site visits to specialized medical and research centers in the United States. The visits aimed to leverage global expertise in the latest technologies and developments within advanced therapies and biotechnology. They took place on the sidelines of Dr. Aljadhey’s participation in the Drug Information Association (DIA) Annual Meeting in Philadelphia, Pennsylvania.

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.

H.E. Dr. Hisham S. Aljadhey, CEO of the Saudi Food and Drug Authority (SFDA), conducted a field inspection tour of several SFDA facilities and operational sites in the Makkah and Eastern Regions as part of the intensive preparations for this year’s Hajj season. The tour aimed to enhance the efficiency of regulatory procedures and ensure the safety of incoming products, contributing to safeguarding the health and safety of pilgrims.

The Saudi Food and Drug Authority (SFDA) has clarified the approved regulations and procedures for obtaining personal clearance permits for medications containing narcotic drugs or psychotropic substances carried by pilgrims for personal use. This initiative is part of the Authority’s ongoing efforts to serve the Guests of Allah, facilitate the performance of their rituals, and ensure the safety and well-being of all visitors to the Holy Sites.