美国食品药品监督管理局（FDA）已向 Applied Therapeutics 公司发出了一份完整回复函（CRL），涉及 govorestat 用于治疗经典半乳糖血症的新药申请（NDA）。 该 NDA 包含 1/2 期 ...

Galactosemia (G) is due to either partial or complete deficiency of the enzyme galactose-1-phosphate uridyl transferase (Ts). In females with G, there is a high incidence of premature ovarian failure.

The NDA for govorestat for the galactosemia indication was accepted by the FDA in late February under its Priority Review pathway. Year to date, shares of Applied Therapeutics have skyrocketed 155 ...

Looking for reliable medications to treat 'Galactosemia'? This page offers a detailed resource for the most up-to-date treatment options, including both generic and brand-name medications.

Applied Therapeutics' (APLT) lead drug candidate, govorestat, likely faces "significant" uncertainty in potentially treating galactosemia after the US Food and Drug Administration rejected the ...

Considering taking supplements to treat galactosemia? Below is a list of common natural remedies used to treat or reduce the symptoms of galactosemia. Follow the links to read common uses ...

In support of its New Drug Application (NDA) for govorestat for the treatment of galactosemia, Applied Therapeutics relied on data from its phase 3 ACTION-Galactosemia Kids trial in children ages ...

Then, on December 2, 2024, Applied Therapeutics disclosed it received a "warning letter" from the FDA referring to the clinical trial issues underlying the CRL. Applied Therapeutics' common stock fell ...