SAN Sanofi

EMA accepts regulatory submission for avalglucosidase alfa, a potentially new standard of care enzyme replacement therapy for Pompe disease

EMA accepts regulatory submission for avalglucosidase alfa, a potentially new standard of care enzyme replacement therapy for Pompe disease
EN
02/10/2020

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Reports on Sanofi

 PRESS RELEASE

Press Release: Sanofi and Regeneron’s Dupixent recommended for EU appr...

Press Release: Sanofi and Regeneron’s Dupixent recommended for EU approval to treat chronic spontaneous urticaria in young children with ongoing symptoms despite treatment Sanofi and Regeneron’s Dupixent recommended for EU approval to treat chronic spontaneous urticaria in young children with ongoing symptoms despite treatment If approved, Dupixent would be the first targeted medicine in the EU indicated for children aged two to 11 years with CSU inadequately controlled by standard-of-care antihistamine treatment CSU is a chronic skin disease with underlying type 2 inflammation that can c...

 PRESS RELEASE

Communiqué de presse : Dupixent de Sanofi et Regeneron recommandé pour...

Communiqué de presse : Dupixent de Sanofi et Regeneron recommandé pour approbation dans l'UE dans le traitement de l'urticaire chronique spontanée chez les jeunes enfants dont les symptômes persistent malgré un traitement   Dupixent de Sanofi et Regeneron recommandé pour approbation dans l'UE dans le traitement de l'urticaire chronique spontanée chez les jeunes enfants dont les symptômes persistent malgré un traitement S’il est approuvé, Dupixent serait le premier médicament ciblé dans l’Union Européenne indiqué chez les enfants âgés de 2 à 11 ans atteints d’UCS insuffisamment contrôlées ...

 PRESS RELEASE

Press Release: Acoziborole Winthrop, developed by DNDi and Sanofi, rec...

Press Release: Acoziborole Winthrop, developed by DNDi and Sanofi, receives CHMP positive opinion as three-tablet, single-dose treatment for most common form of sleeping sickness Acoziborole Winthrop, developed by DNDi and Sanofi, receives CHMP positive opinion as three-tablet, single-dose treatment for most common form of sleeping sickness  Recommendation based on phase 2/3 study demonstrating up to 96 percent success rates at 18 months across both early and advanced stages of T.b. gambiense, the most common form of sleeping sicknessThe therapy, given as a single dose of three tablets, c...

 PRESS RELEASE

Communiqué de presse: L’acoziborole Winthrop, développé par DNDi et Sa...

Communiqué de presse: L’acoziborole Winthrop, développé par DNDi et Sanofi, reçoit l’avis positif du CHMP comme traitement à dose unique à trois comprimés pour la forme la plus fréquente de la maladie du sommeil L’acoziborole Winthrop, développé par DNDi et Sanofi, reçoit l’avis positif du CHMP comme traitement à dose unique à trois comprimés pour la forme la plus fréquente de la maladie du sommeil  La recommandation s’appuie sur une étude de phase 2/3, qui démontre jusqu’à 96 % de taux de réussite à 18 mois à des stades précoces et avancés de T.b. gambiense, la forme la plus courante de ...

 PRESS RELEASE

Press Release: Sanofi and Regeneron’s Dupixent approved in the US as t...

Press Release: Sanofi and Regeneron’s Dupixent approved in the US as the first and only medicine for allergic fungal rhinosinusitis Sanofi and Regeneron’s Dupixent approved in the US as the first and only medicine for allergic fungal rhinosinusitis Approval in adults and children aged 6 years and older supported by phase 3 study demonstrating Dupixent significantly reduced nasal signs and symptoms and systemic corticosteroid use or surgery compared to placeboAFRS is a chronic type 2 inflammatory disease of the sinuses characterized by an allergic hypersensitivity to fungi, often requiring ...

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