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

Colorado and Florida are among at least nine states that have passed laws allowing for Canadian drug importation. Colorado's ...

Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track ...

The FDA has approved Rapiblyk, a new drug to treat irregular heartbeats in critically ill hospitalized patients with severe ...

As e-cigarettes have flooded the market, the FDA's role in approving new tobacco products is put under a microscope.

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

The FDA has approved Attruby, a new oral treatment that helps reduce heart-related deaths and hospital visits among adults ...

Yesintek is the latest Stelara biosimilar to gain FDA approval and it will be available in February 2025.

Applied Therapeutics said on Wednesday that the U.S. FDA declined to approve its drug to treat galactosemia, a rare genetic ...

Collaboration with Janssen aims to fast-track the launch and enhance accessibility to YESINTEK for patients in need.

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 ...

The FDA granted approval to nilotinib (Danziten) on November 14, 2024, for the treatment of adult patients with newly ...