Hosted on MSN10mon
FDA extends review period for Applied Therapeutics’ govorestat NDA
The NDA is supported by data demonstrating a quick ... and we will continue to work closely with the FDA throughout the review process. “During this time, we are committed to maintaining the ...
Monthly Prescribing Reference3d
Nasal Spray Formulation of Bumetanide Under FDA Review
The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.