Reinforcing its position as a leading global regulatory authority, the Saudi Food and Drug Authority (SFDA) has launched the New Accelerator Program for Drugs in Rare Diseases (NADR), a specialized regulatory initiative designed to support the development of and access to medicines for rare diseases, empower researchers and developers, and advance healthcare innovation.

The Saudi Food and Drug Authority (SFDA) has approved the registration of ZENBEXUS (iberdomide) for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with daratumumab and dexamethasone. The SFDA is the first regulatory authority globally to approve the registration of this product. Multiple myeloma is a blood cancer originating in plasma cells within the bone marrow which can lead to anaemia, a low white blood cell count, and weakened immunity, in addition to impaired kidney function and bone damage.

The Saudi Food and Drug Authority (SFDA) has approved the registration of Foundayo (orforglipron) to help reduce excess body weight and maintain long-term weight loss in adults with obesity, or adults who are overweight accompanied by at least one weight-related comorbid condition. It is used as an adjunct to a healthy diet and physical activity.

Innovative Mechanism of Action

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.