The Saudi Food and Drug Authority (SFDA) has granted Santhera Pharmaceuticals orphan drug designation to Agamree (vamorolone), which is indicated for the treatment of patients with Duchenne muscular dystrophy (DMD).

Registration is Subject to Full Scientific Evaluation

The Saudi Food and Drug Authority (SFDA) has granted Bayer orphan drug designation to Hyrnuo (Sevabertinib), which is indicated for the treatment of adult patients with advanced non-squamous non-small cell lung cancer (NSCLC) who have received a prior systemic therapy.

Registration is Subject to Full Scientific Evaluation

The Saudi Food and Drug Authority (SFDA) has granted Boehringer Ingelheim orphan drug designation to Jascayd (nerandomilast), which is indicated for the treatment of adult patients with Idiopathic Pulmonary Fibrosis (IPF).

Registration is Subjected to Full Scientific Evaluation

H.E. Dr. Hisham S. Aljadhey, CEO of the Saudi Food and Drug Authority (SFDA), affirmed that artificial intelligence (AI) contributes to accelerating the delivery of medicines to patients by supporting drug development and discovery. By simulating clinical trials, AI enables medicines to enter the market in a shorter time and at a lower cost, shortening a process that traditionally takes several years.

The Saudi Food and Drug Authority (SFDA) recorded significant growth in the number of licensed factories and warehouses during 2025, achieving a 18% increase compared to 2024. This growth reflects the ongoing development of the regulatory environment, the empowerment of the industrial sector, and the expansion of investment support within the SFDA’s scope of work.

According to official statistics, the total number of licensed facilities reached 9,155 in 2025, up from 7,750 in 2024.

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.