BRIEF published on 01/19/2026 at 07:35, 7 months 4 days ago Advicenne : Demande de mise sur le marché de Sibnayal® acceptée par la FDA FDA Advicenne ATRd Sibnayal® PDUFA
BRIEF published on 01/19/2026 at 07:35, 7 months 4 days ago La FDA examine le Sibnayal® d'Advicenne en vue de son approbation aux États-Unis. FDA Advicenne Sibnayal® DRTA Date PDUFA
BRIEF published on 01/19/2026 at 07:35, 7 months 4 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, 7 months 4 days ago Advicenne: FDA-approved marketing application for Sibnayal® FDA ATRd Advicenna Sibnayal® PDUFA
PRESS RELEASE published on 01/19/2026 at 07:30, 7 months 4 days ago Informations privilégiées / Autres communiqués Advicenne annonce l'acceptation de Sibnayal pour examen par la FDA aux Etats-Unis pour le traitement de l’ATRd. Date PDUFA fixée au 3 septembre 2026 FDA Advicenne ATRd Sibnayal PDUFA
PRESS RELEASE published on 01/19/2026 at 07:30, 7 months 4 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, 7 months 11 days ago Renewal of the marketing authorization for Sibnayal® in the European Union Kidney Disease EMA Advicenna AMM Sibnayal®
BRIEF published on 01/12/2026 at 07:35, 7 months 11 days ago Renouvellement de l'AMM de Sibnayal® dans l'Union Européenne Advicenne Maladies Rénales EMA AMM Sibnayal®
PRESS RELEASE published on 01/12/2026 at 07:30, 7 months 11 days ago Informations privilégiées / Autres communiqués Advicenne annonce le succès du renouvellement de l’AMM de Sibnayal® dans l’Union Européenne. L'EMA a validé l'autorisation de mise sur le marché, renforçant le développement commercial de Sibnayal® Renouvellement Union Européenne Advicenne AMM Sibnayal
BRIEF published on 11/04/2025 at 11:35, 9 months 19 days ago Advicenne soumet Sibnayal® à la FDA américaine FDA Advicenne Sibnayal® Acidose Tubulaire Rénale Dépôt D'enregistrement
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