PRESS RELEASE published on 01/19/2026 at 07:30, 5 months 25 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
PRESS RELEASE published on 01/19/2026 at 07:30, 5 months 25 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
BRIEF published on 01/12/2026 at 07:35, 6 months 1 day 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, 6 months 1 day 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, 6 months 1 day 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, 8 months 9 days ago Advicenne submits Sibnayal® to the US FDA FDA Advicenna Sibnayal® Renal Tubular Acidosis Registration Filing
BRIEF published on 11/04/2025 at 11:35, 8 months 9 days ago Advicenne soumet Sibnayal® à la FDA américaine FDA Advicenne Sibnayal® Acidose Tubulaire Rénale Dépôt D'enregistrement
PRESS RELEASE published on 11/04/2025 at 11:30, 8 months 9 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
PRESS RELEASE published on 11/04/2025 at 11:30, 8 months 9 days ago Informations privilégiées / Autres communiqués Advicenne dépose le dossier d'enregistrement de Sibnayal® auprès de la FDA américaine pour le traitement de l'ATRd. Webconférence le 5 novembre 2025. Informations sur ADV7103 et le développement clinique FDA Advicenne Webconférence ATRd Sibnayal
BRIEF published on 09/19/2025 at 18:05, 9 months 24 days ago Advicenne: Half-year results in 2025 and outlook Financial Results Outlook Turnover United States Sibnayal®
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