Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration ...

The warning letter did not identify any new observations that had not already been provided in the Form 483s previously issued to the company by the FDA at the conclusion of its three inspections ...

In a warning ... The letter stems from an inspection that took place at the facility between June 14-26, 2024. The FDA’s review of the site yielded a six-observation Form 483, which the company ...