Mon 26 Oct 2026
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2026-10-19
SFDA Grants Breakthrough Designation to "Povetacicept" for Adults with Primary Immunoglobulin A Nephropathy
The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to “Povetacicept”, developed by Vertex Pharmaceuticals Inc., under the...
2026-10-07
SFDA Grants Breakthrough Designation to "Wilsirdli" for Early, Advanced, and Metastatic ER+/HER2- Breast Cancer
The Saudi Food and Drug Authority (SFDA) has approved a request by Roche Pharmaceuticals to designate "Wilsirdli" under its Breakthrough Medicine...
2026-09-10
SFDA Grants Marketing Authorization for Two Saudi-Developed AI-Enabled Medical Software Products for Dental and Ophthalmic Diagnosis
The Saudi Food and Drug Authority (SFDA) has granted marketing authorization for two locally developed, AI-enabled medical software products designed...
2026-03-03
SFDA Grants Orphan Drug Designation to "Agamree" for Duchenne Muscular Dystrophy
The Saudi Food and Drug Authority (SFDA) has granted Santhera Pharmaceuticals orphan drug designation to Agamree (vamorolone), which is indicated for...
2026-03-02
SFDA Grants Orphan Drug Designation to "HYRNUO" for Advanced Non-Small Cell Lung Cancer
The Saudi Food and Drug Authority (SFDA) has granted Bayer orphan drug designation to Hyrnuo (Sevabertinib), which is indicated for the treatment of...
2026-01-29
SFDA Grants Orphan Drug Designation to “Jascayd”
The Saudi Food and Drug Authority (SFDA) has granted Boehringer Ingelheim orphan drug designation to Jascayd (nerandomilast), which is indicated for...Last update date: 19/10/2026 at 07:30 AM Saudi Arabia time
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