pharmaphorum1h
Warning letter adds to Applied Tx run of bad news
Applied Therapeutics has been sent a warning letter from the FDA over a clinical trial of its rare disease therapy govorestat ...
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 ...
BioPharma Dive1d
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 ...
Monthly Prescribing Reference1d
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 ...
BioSpace1d
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’ ...
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 ...
Applied Therapeutics: FDA Denial Of Govorestat NDA As Problematic As It Was Unexpected
Applied Therapeutics faces challenges after FDA rejection, but future opportunities exist. Learn why APLT stock could recover ...
RBC says if Applied’s govorestat were to be approved, would likely hear today
PDUFA for govorestat is tomorrow, November 28th, though given that the day falls on a holiday, there is some uncertainty around when a potential decision could be announced. The firm’s analysis of ...
Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat
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Regulatory Setback For Applied Therapeutics' Lead Program, FDA Highlights Deficiencies In Clinical Application
FDA rejected Applied Therapeutics' Govorestat for galactosemia, citing NDA deficiencies. The company plans discussions for ...
Morningstar6d
Govorestat, First and Only Potential Treatment for Classic Galactosemia, Does Not Receive FDA Approval
Govorestat is the first and only investigational treatment to be evaluated for Galactosemia, a rare genetic disease that can be life-threatening for newborns and can cause severe lifelong ...