Sat 15 Aug 2026
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2025-07-29
SFDA Approves the Registration of “Leqembi” as the First Alzheimer’s Treatment in Saudi Arabia
The Saudi Food and Drug Authority (SFDA) has approved the registration of Leqembi (lecanemab) for the treatment of patients with mild cognitive...
2025-07-23
SFDA Announces Registration of “Skyclarys” for the Treatment of a Rare Genetic Neurological Disorder
The Saudi Food and Drug Authority (SFDA) has approved the registration of Skyclarys (Omaveloxolone), which was previously designated as an Orphan Drug...
2025-07-20
SFDA Welcomes Submissions for the 5th Regulatory Research Day 2025
The Saudi Food and Drug Authority (SFDA) is pleased to announce that it is now accepting scientific submissions for the 5th Regulatory Research Day...
2025-05-26
The SFDA Grants Breakthrough Designation to "Itovebi" for Advanced Hormone Resistant Breast Cancer Treatment
The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to Itovebi (Inavolisib( developed by Roche. The investigational therapy...
2025-05-22
The SFDA Grants Breakthrough Designation to “MIQNAF” for Acute Bacterial Infections Treatment
The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to MIQNAF (Nafithromycin), developed by Wockhardt Bio AG. This...
2025-05-05
The SFDA Approves Breakthrough Designation Application for Breast Cancer Therapy “Inluriyo”
The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to Eli Lilly’s medication, Imlunestrant (Inluriyo), for the treatment of...Last update date: 13/08/2026 at 12:55 PM Saudi Arabia time
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