The FDA’s Priority Review designation allows for a shortened review period (within 6 months) from the time of application acceptance.
The Food and Drug Administration (FDA) has granted accelerated approval to Voyxact ® (sibeprenlimab-szsi) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for ...
GLP-1 RA use with subsequent prepregnancy or early pregnancy discontinuation linked to higher risk for preterm delivery, gestational diabetes ...