BRIEF published on 01/19/2026 at 07:35, 11 days ago FDA Reviews Advicenne's Sibnayal® for U.S. Approval FDA Advicenne Sibnayal® DRTA PDUFA Date
BRIEF published on 01/19/2026 at 07:35, 11 days ago Advicenne: FDA-approved marketing application for Sibnayal® FDA ATRd Advicenna Sibnayal® PDUFA
PRESS RELEASE published on 01/19/2026 at 07:30, 11 days ago Inside Information / Other news releases FDA accepts Advicenne's Marketing Authorization Application for Sibnayal® for dRTA treatment in the US, with a PDUFA decision target date of September 3rd, 2026 FDA Advicenne Sibnayal DRTA PDUFA
BRIEF published on 01/12/2026 at 07:35, 18 days ago Renewal of the marketing authorization for Sibnayal® in the European Union Kidney Disease EMA Advicenna AMM Sibnayal®
BRIEF published on 11/04/2025 at 11:35, 2 months 25 days ago Advicenne submits Sibnayal® to the US FDA FDA Advicenna Sibnayal® Renal Tubular Acidosis Registration Filing
PRESS RELEASE published on 11/04/2025 at 11:30, 2 months 25 days ago Inside Information / Other news releases Advicenne submits registration application for Sibnayal® in dRTA treatment to US FDA, designated orphan drug. Evaluation process expected to take 12 months Advicenne Sibnayal® US FDA DRTA Treatment Registration Application
BRIEF published on 09/19/2025 at 18:05, 4 months 10 days ago Advicenne: Half-year results in 2025 and outlook Financial Results Outlook Turnover United States Sibnayal®
BRIEF published on 07/28/2025 at 07:35, 6 months 2 days ago Advicenne Secures Marketing Authorization for Sibnayal® in Saudi Arabia Saudi Arabia Advicenne Reimbursement Sibnayal® DRTA
PRESS RELEASE published on 07/28/2025 at 07:30, 6 months 2 days ago Inside Information / Other news releases Advicenne obtains marketing authorization and reimbursement for Sibnayal® in Saudi Arabia, a fixed combination for rare kidney diseases, in collaboration with Taïba Healthcare Saudi Arabia Advicenne Reimbursement Marketing Authorization Sibnayal
BRIEF published on 07/25/2025 at 07:35, 6 months 5 days ago Advicenne Announces 9% Revenue Growth for H1 2025 Growth Turnover Advicenna Sibnayal® Pharmaceutical Markets
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