An FDA complete response letter indicates that an application can't be approved in its current form. Govorestat, the company's lead drug candidate, is also being developed for treatment of sorbitol ...
The customers came from far and wide on a sunny November morning. They strolled past raw buffalo ice cream, raw chocolate milk and camel milk, grabbed raw cottage cheese, raw butter, raw lemon yogurt, ...
Applied Therapeutics said it has received a complete response letter from the Food and Drug Administration related to its new drug application for govorestat due to deficiencies in the clinical ...
On Tuesday night, Trump nominated Dr. Jay Bhattacharya to lead the National Institutes of Health, tapping an opponent of ...
Becton Dickinson's HPV assay was FDA-approved for use with clinician-collected samples in 2018 and received approval for sample self-collection in May.
Applied Therapeutics said on Wednesday that the U.S. FDA declined to approve its drug to treat galactosemia, a rare genetic ...
Avoid getting yourself (and your guests) sick this holiday season and take these food safety tips into consideration.
The Supreme Court continues its probe of federal agency authority next week, putting the Food and Drug Administration’s ...
The firm's HPV assay was FDA-approved for use with clinician-collected samples in 2018 and received approval for sample self-collection in May.
Named to lead the nation's sprawling Department of Health and Human Services, Robert F. Kennedy Jr. has big ideas for busting ...
Americans should support Kennedy's nomination. He is the best chance of reigning in corruption and corporate power while ...
The approval was based on data from 5 randomized, double-blind, placebo-controlled trials that included 317 patients with supraventricular tachycardia.