The waiting time for Latin American patients with cancer, central nervous system disorders or rare diseases can take up to ...

Applied Therapeutics stock plummets 77% after the FDA issues a CRL for the company's NDA seeking approval for govorestat to treat classic galactosemia.

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for ...

An unprofitable software company has become one of the market’s hottest stocks, with the help of 386,700 bitcoins and a ...

Applied Therapeutics faces challenges after FDA rejection, but future opportunities exist. Learn why APLT stock could recover ...

In a post on X.com, Neuralink said it had been granted regulatory approval for "a new feasibility trial to extend BCI control ...

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

The sell-off started last night and continued in after-hours trading after the New York-based biopharma company revealed that ...

Applied Therapeutics (APLT) announced the FDA has issued a Complete Response Letter for the New Drug Application for govorestat, for ...

Applied Therapeutics (APLT) announced that the FDA has issued a Complete Response Letter – CRL – for the New Drug Application – NDA – for ...

An FDA complete response letter indicates that an application can't be approved in its current form. Govorestat, the company's lead drug candidate, is also being developed for treatment of sorbitol ...

The FDA rejected Applied Therapeutics’ experimental treatment, govorestat, for a rare disease called classic galactosemia, ...