The Saudi Food and Drug Authority (SFDA) announced its approval of a new medical claim for Lojuxta (lomitapide), allowing its use to treat children aged 5 years and older diagnosed with Homozygous Familial Hypercholesterolemia (HoFH). This approval positions SFDA as the first regulatory authority worldwide to authorize the pediatric use of Lojuxta, highlighting its global leadership in improving access to advanced therapies for rare disorders.
Mechanism of Action of Lojuxta

The Saudi Food and Drug Authority (SFDA) has signed an agreement with the Uppsala Monitoring Centre (UMC) in Sweden to connect Saudi Arabia’s national pharmacovigilance database with the World Health Organization’s (WHO) global system for Individual Case Safety Reports (ICSRs)—the world’s central hub for monitoring adverse drug reactions.

On Wednesday, November 19, the Saudi Food and Drug Authority (SFDA), in cooperation with the Waey Association for Community Health, held a scientific forum at its headquarters in Riyadh entitled, "Knowledge is a Responsibility: Towards National Awareness to Reduce Antimicrobial Resistance." The forum aimed to raise awareness about antimicrobial resistance (AMR) and was attended by representatives from several government agencies and relevant health associations

The Saudi Food and Drug Authority (SFDA) has approved the registration of Pemazyre (Pemigatinib) as a monotherapy for adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement, who have progressed after at least one prior line of systemic therapy.

Inhibition of Signals that Stimulate Cancer Cell Growth

The CEO of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, launched the National Network for Drugs and Medical Products Safety During Pregnancy and Breastfeeding on the sidelines of the SFDA's participation in the Global Health Exhibition. The Exhibition was held in Riyadh from October 27–30, with the participation of more than 2,000 entities from around the world.

The CEO of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, launched the Regulatory AI System for Incoming Drugs (RASID) smart service, which utilizes artificial intelligence technologies to regulate and control the entry of controlled medications carried by travelers. The launch took place during the Global Health Exhibition, held from October 27 to 30 at the Riyadh International Convention and Exhibition Center in Malham. 

The CEO of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, launched an AI-powered model for predicting drug shortages in the Kingdom of Saudi Arabia. The launch took place during the Global Health Exhibition, held from October 27 to 30. It highlights the SFDA's commitment to enhance drug monitoring and proactively address any potential shortages.

The CEO of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, launched the “Saudi Pharmacopoeia” on the sidelines of the SFDA's participation in the Global Health Exhibition (GHE) held at the Riyadh Exhibition and Convention Center in Malham from October 27 to 30, under the theme “Invest in Health.”

The International Coalition of Medicines Regulatory Authorities (ICMRA) announced the full membership of the Kingdom of Saudi Arabia, represented by the Saudi Food and Drug Authority (SFDA). This achievement makes the SFDA the first regulatory authority from the Middle East and North Africa (MENA) to become full member in ICMRA.