The Saudi Food and Drug Authority (SFDA) has granted breakthrough designation to Sanofi's medication, Fitusiran (Qfitlia), which is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and adolescent patients aged 12 years and older with hemophilia A or B, with or without factor VIII or IX inhibitors.

The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to Eli Lilly’s medication, Imlunestrant (Inluriyo), for the treatment of advanced breast cancer. Imlunestrant is being developed as a monotherapy for the treatment of adult patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer who have previously been treated with an endocrine based regimen.

Imlunestrant: A Selective Estrogen Receptor Inhibitor

Experimental Treatment by mRNA

The Saudi Food and Drug Authority (SFDA) has approved a clinical study registration titled "A Global Phase 1/2 Open-Label Dose-Optimization Study to Evaluate the Safety and Pharmacokinetics of the Biologic Treatment (mRNA-3927) in Participants with Propionic Acidemia." This research will investigate an innovative experimental therapy utilizing messenger RNA (mRNA) technology to address a rare inherited disorder affecting amino acid metabolism.

The Saudi Food and Drug Authority (SFDA) is continuously advancing its regulatory framework and boosting its operational effectiveness. This aligns with the Health Sector Transformation Program, a key pillar of Saudi Vision 2030.

During the Hajj season, the SFDA intensifies its focus on employing technologies to protect pilgrim health and safety by providing top-tier quality control and regulatory services that meet the highest standards.

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The Saudi Food and Drug Authority (SFDA) has successfully completed the clearance procedures for the first medical shipment intended for this year's Hajj pilgrims. The shipment arrived via Prince Mohammed bin Abdulaziz International Airport in Medina, weighing 44 tons and consisting of essential medicines and medical products.

The Saudi Food and Drug Authority (SFDA) and the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) have signed a Memorandum of Understanding (MoU) focused on the management of veterinary medicinal products. The agreement aims to strengthen collaboration and facilitate the exchange of information and expertise between the two parties.

The signing took place in Paris, France, during the official visit of H.E. Mr. Fahad Abdulrahman AlJalajel, the Minister of Health of Saudi Arabia and Chairman of the SFDA Board of Directors.

The Saudi Food and Drug Authority (SFDA) hosted the Drug Innovation Conference, timed to coincide with World Creativity and Innovation Day. The event, held at the SFDA's headquarters in Riyadh, drew participation from officials representing government authorities, research centers, and universities.