Search Results

The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical trial—including a dosing error for govorestat—claims that the company said it had already addressed.

PINC AI™ Applied Sciences, a division of Premier, Inc., and Datavant, the company that protects, connects and delivers the world’s health data, announce the companies are expanding their existing collaboration to help shape the future of healthcare research, advance clinical trial operations, and increase trial diversity and equity – aiming to accelerate the development of novel therapies and products for improved patient outcomes.

Premier, Inc.’s PINC AI™ Applied Sciences (PAS) and TFS HealthScience are announcing a landmark collaboration to accelerate global clinical trials and research innovation, improve patient outcomes and reduce health disparities.

Massachusetts’ increased investment in the life sciences industry includes boosting its life sciences tax incentive program by $10 million annually, aiding job creation in the state.

After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ govorestat for galactosemia, citing “deficiencies” with the application. The biotech plans to meet with the regulator to discuss the best way forward for the drug.

Following a 90% drop in share price due to an FDA rejection and a warning letter over Applied Therapeutics’ conduct during a clinical trial, the biotech’s CEO has stepped aside.

Applied DNA Sciences, Inc. announced that its molecular diagnostics subsidiary, Applied DNA Clinical Labs, LLC, will utilize the GenXys Health Care Systems suite of clinical decision support software for interpretation and reporting of ADCL’s New York State Department of Health-approved TR8™ pharmacogenomic test.

Applied DNA Sciences, Inc., a leader in PCR-based DNA technologies, announced the pricing of a public offering with gross proceeds to the Company expected to be approximately $12.0 million, before deducting placement agent fees and other estimated expenses payable by the Company.

LANGaware, an innovative leader in digital cognitive and behavioral health diagnostics, is announcing that it will partner with Premier’s (NASDAQ: PINC) PINC AI™ Applied Sciences (PAS) to leverage Real-World Data (RWD) for the development of novel therapeutics addressing neurodegenerative and behavioral health diseases.