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An official government website affiliated with the Government of the Kingdom of Saudi Arabia.
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All official websites of government entities in the Kingdom of Saudi Arabia end with.gov.sa.

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All official websites of government entities in the Kingdom of Saudi Arabia end with.gov.sa.

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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 Advances Healthcare Innovation Through Clinical Trials and Gene Therapy

The Saudi Food and Drug Authority (SFDA) continues to drive healthcare innovation across the Kingdom of Saudi Arabia. It's doing this through a series...
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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 2025-07-16

SFDA Approves Marketing Authorization for Diagnostic Medical Devices to Measure Antipsychotic Drug Levels in Blood

The Saudi Food and Drug Authority (SFDA) has approved the marketing authorization for in-vitro diagnostic medical devices that utilize biotechnology...
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45674356
icon 2025-07-14

SFDA Suspends European Pharmaceutical Factory Due to Critical Manufacturing Violations

The Saudi Food and Drug Authority (SFDA) has announced the suspension of a European pharmaceutical factory's registration. This decisive action...
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icon 2027-07-10

The SFDA Approves the Registration of “Winrevair” for the Treatment of Pulmonary Arterial Hypertension under the Orphan Drug Designation Pathway

The Saudi Food and Drug Authority (SFDA) has approved the registration of Winrevair (Sotatercept), which has been designated as an orphan drug under...
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