FierceBiotech11h
Applied Therapeutics' trial conduct scrutinized in FDA warning letter
While Applied Therapeutics has vowed to reapply or appeal the FDA’s recent rejection of its rare disease candidate govorestat ...
BioSpace14h
FDA Warns Applied Therapeutics of ‘Objectionable Conditions’ in Govorestat Study
The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical ...
Applied Therapeutics says it received FDA's warning letter for genetic disease drug study
Applied Therapeutics said on Monday it received a warning letter limited to a trial studying its genetic disease drug, after ...
BioPharma Dive2d
Applied’s rare disease drug rejected by FDA
Executives at Applied Therapeutics told analysts they were surprised by the agency’s refusal to approve the company’s ...
BioSpace2d
Applied Therapeutics Crashes After FDA Rejection of Rare Disease Drug
After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ ...
FierceBiotech2d
FDA rejects Applied filing for rare disease approval on clinical grounds, sinking stock
The FDA has rejected Applied Therapeutics’ attempt to win approval on the strength of a failed phase 3 trial, triggering a 75 ...
Zacks.com on MSN6d
APLT Stock Plunges 77% After FDA Issues CRL for Galactosemia Drug NDA
Applied Therapeutics APLT announced that the FDA has issued a Complete Response Letter (CRL) for the new drug application ...
Monthly Prescribing Reference2d
FDA Denies Approval of Govorestat for Classic Galactosemia
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 ...
APLT ALERT- Levi & Korsinsky Has Commenced an Investigation on Behalf of Applied Therapeutics, Inc. Shareholders Who Lost Money
NEW YORK, NY / ACCESSWIRE / December 4, 2024 / Levi & Korsinsky notifies investors that it has commenced an investigation of Applied ...
Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat
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Applied Therapeutics Stock Plummets After FDA Rejects Metabolic Disease Drug
Applied Therapeutics' New Drug Application for a rare metabolic disease was rejected by the Food and Drug Administration, ...