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7 ώρες πριν · Applied Therapeutics said on Monday it received a warning letter limited to a trial studying its genetic disease drug, after the U.S. health regulator declined to approve the treatment last week.
4 ημέρες πριν · TauRx Pharma's effort to bring a tau-targeting drug for Alzheimer's disease (AD) to market has been a marathon, with a number of setbacks over the years, but the company reckons it may finally...
3 ημέρες πριν · Applied Therapeutics' New Drug Application for a rare metabolic disease was rejected by the Food and Drug Administration, causing its shares to crater Friday. News Today's news
5 ημέρες πριν · The US Food and Drug Administration (FDA) has declined to approve Applied Therapeutics’ govorestat for classic galactosemia, prolonging the wait for the first marketed treatment for the genetic disease.. US-based Applied Therapeutics had been hoping its central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI) would become the first pharmacological treatment for the disease.
3 ημέρες πριν · Search News & Quotes. Topics Stock Picks Lists & Rankings Magazine Data Advisor. Biotech and Pharma; Applied Therapeutics Stock Plummets 73%. The FDA Delivers This Crushing Blow. By George Glover ...
6 ημέρες πριν · Sarepta Therapeutics and Arrowhead Pharmaceuticals teamed up on an siRNA partnership that has one of the biggest promises of biobucks in recent years ...
1 ημέρα πριν · Applied Therapeutics crashes after FDA rejection of rare disease drug. The FDA last week denied approval for Applied Therapeutics’ investigational aldose reductase inhibitor govorestat for the treatment of classic galactosemia, sending the New York biotech’s stocks plunging more than 80%. Galactosemia is a rare genetic metabolic disorder that affects around 3,000 patients in the U.S.