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Thursday, July 3, 2025

Tag: TRI FDA

Lundbeck receives orphan drug designation in the US and EU for Lu AG13909 for the treatment of patients with congenital adrenal hyperplasia

Congenital adrenal hyperplasia (CAH) is a rare autosomal recessive disease1 with an estimated global incidence of approximately 1 in 14,000–18,000 live births2A phase II...

Lundbeck receives orphan drug designation in the US and EU for Lu AG13909 for the treatment of patients with congenital adrenal hyperplasia

Congenital adrenal hyperplasia (CAH) is a rare autosomal recessive disease1 with an estimated global incidence of approximately 1 in 14,000–18,000 live births2A phase II...

U.S. Food and Drug Administration Approves CSL’s ANDEMBRY® (garadacimab-gxii), the Only Prophylactic Hereditary Angioedema (HAE) Treatment Targeting Factor XIIa with Once-Monthly Dosing for All...

ANDEMBRY inhibits the top of the HAE cascade by targeting factor XIIa and provides sustained protection from attacksOnce-monthly dosing reduced HAE attacks by a...

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