Applied Therapeutics said on Monday it received a warning letter limited to a trial studying its genetic disease drug, after ...

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Applied Therapeutics regarding the New Drug Application (NDA) for govorestat for the treatment of classic ...

Novartis will partner with PTC Therapeutics to develop PTC’s PTC518 Huntington's disease program and an unspecified number of related molecules, through an up-to-$2.9 billion exclusive global license ...

Pomerantz LLP is investigating claims on behalf of investors of Applied Therapeutics, Inc. ("Applied Therapeutics" or the "Company") . Such investors are advised to contact Danielle Peyton at ...

Executives at Applied Therapeutics told analysts they were surprised by the agency’s refusal to approve the company’s ...

The breast cancer drug Enhertu will be added to China’s national health insurance scheme beginning in the new year — despite ...

Former FDA Commissioner Scott Gottlieb, MD, warned " it will cost lives " if Robert F. Kennedy Jr. is allowed to implement ...

Shares of Applied Therapeutics (APLT) plummeted 76.3% after the FDA rejected approval for its drug intended to treat a rare genetic metabolic disorder. Target Corporation’s (TGT) shares jumped 1.7% on ...

After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ ...

The FDA has rejected Applied Therapeutics’ attempt to win approval on the strength of a failed phase 3 trial, triggering a 75 ...

The pharma company's shares are getting crushed after regulators decline to green light a drug to treat a rare disease.

Chip and crypto stocks rose, while Applied Therapeutics fell sharply after FDA denial. This image is AI-generated and does ...