It’s easy to test for galactosemia. It’s also simple to treat once it’s diagnosed. And children who have it can live normal lives. Type I occurs in about 1 in every 30,000 to 60,000 people.

The US Food and Drug Administration (FDA) has declined to approve Applied Therapeutics’ govorestat for classic galactosemia, ...

Nearly three months after an experimental treatment for classic galactosemia was rejected by the US Food and Drug ...

Galactosemia is an inherited genetic disorder of metabolism where the body is unable to metabolize a sugar called galactose. Galactose forms half of the sugar lactose, which is found in milk. The ...

The NDA for govorestat for the galactosemia indication was accepted by the FDA in late February under its Priority Review pathway. A filing designated as a Priority Review reduces the review ...

Applied Therapeutics is a clinical-stage biotech focused on treating symptoms of galactosemia in the central nervous system. Govorestat (AT-007) is in late-stage regulatory approval for ...

Galactosemia is a rare genetic disorder that results from the body’s inability to properly metabolize galactose, converting instead to the toxic metabolite, galactitol, which is known to cause ...

Galactosemia is a rare genetic disorder that causes an inability to digest galactose, which is a breakdown product of lactose. Lactose is one of the main carbohydrates in milk. In the infant ...

Shares of Applied Therapeutics APLT surged 68.8% on Wednesday after it announced a regulatory update regarding the ongoing new drug application (NDA) review of APLT’s lead candidate, govorestat ...