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An official government website affiliated with the Government of the Kingdom of Saudi Arabia.
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icon 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...
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icon 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...
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45674356
icon 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...
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45674356
icon 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...
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The SFDA Approves Breakthrough Designation Application for Breast Cancer Therapy “Inluriyo”
icon 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...
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The SFDA Grants Breakthrough Designation to Qfitlia for Hemophilia A and B
icon 2025-05-09

The SFDA Grants Breakthrough Designation to Qfitlia for Hemophilia A and B

The Saudi Food and Drug Authority (SFDA) has granted breakthrough designation to Sanofi's medication, Fitusiran ( Qfitlia), which is indicated for...
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