The Saudi Food and Drug Authority (SFDA) has granted conditional approval for Anktiva (nogapendekin alfa inbakicept) in combination with immunotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed after standard of care. The SFDA is the first regulatory authority globally to grant conditional approval for this medication for the treatment of NSCLC.

The Kingdom of Saudi Arabia recorded a landmark 83% growth in the number of clinical trails applications submitted to the Saudi Food and Drug Authority (SFDA) for advanced therapies and biotechnology products in 2025, compared to the previous year. This was accompanied by a 39% overall increase in early-stage clinical trials.

The Saudi Food and Drug Authority (SFDA) successfully concluded the Generic Drugs Conference, themed "Empowering Local Pharmaceutical Manufacturing," held at its headquarters in Riyadh on Tuesday. The conference was attended by the SFDA CEO, H.E. Dr. Hisham S. Aljadhey, alongside representatives from regulatory bodies, pharmaceutical companies, healthcare providers, and a distinguished group of investors and academic experts.

The Saudi Food and Drug Authority (SFDA) has approved the registration of Qfitlia (Fitusiran) 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), through its educational arm, the Food and Drug Academy, and in cooperation with the SFDA Drug Sector, conducted a training program for specialists from the Gulf Health Council (GHC). The program was held on December 3–4 at the SFDA headquarters in Riyadh.

The Saudi Food and Drug Authority (SFDA) continues to advance a new phase of regulatory innovation through comprehensive digital transformation initiatives aimed at enhancing drug safety, pharmacovigilance, and strengthening oversight of cosmetic products.

The Saudi Food and Drug Authority (SFDA) is organizing a Generic Drug Conference, titled "Empowering Local Pharmaceutical Manufacturing: The Future of Generic Drugs in Saudi Arabia," on Tuesday, December 30, 2025, in Riyadh. The conference aims to build a resilient, sustainable pharmaceutical sector that supports public health.

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.