Mon 26 Oct 2026
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2026-01-28
SFDA Grants Orphan Drug Designation to “Sephience”
The Saudi Food and Drug Authority (SFDA) has granted PTC Therapeutics orphan drug designation to Sephience (sepiapterin), which is indicated for the...
2026-07-22
SFDA Grants Orphan Drug Designation to Gritgen Therapeutics for PKU Treatment
The Saudi Food and Drug Authority (SFDA) has granted orphan drug designation to Gritgen Therapeutics Co., Ltd. for its “GS1168 Injection” intended for...
2026-05-24
SFDA GrantsBreakthroughDesignation toPrevent and ReduceBleedingEpisodes in Patients with HemophiliaA
The Saudi Food and Drug Authority (SFDA) has granted Novo Nordisk Breakthrough designation to (FREHEMGO), which is indicated as a long-term routine...
2026-07-21
SFDA Suspends Registration of Drug Tavneos (avacopan)
The Saudi Food and Drug Authority (SFDA) has announced the suspension of the registration for the drug (Avacopan), commercially known as Tavneos. 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...
2025-05-04
The SFDA Approves Clinical Trial for Novel Biologic Therapy for Genetic Propionic Acidemia
Experimental Treatment by mRNA The Saudi Food and Drug Authority (SFDA) has approved a clinical study registration titled "A Global Phase 1/2 Open...Last update date: 19/10/2026 at 07:30 AM Saudi Arabia time
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