The FDA is launch­ing a pi­lot pro­gram to col­lect and re­view clin­i­cal tri­al da­ta in re­al time, giv­ing sci­en­tif­ic re­view­ers ac­cess to the da­ta as...

The FDA said Fri­day it has is­sued new fast-track vouch­ers to three psy­che­del­ic com­pa­nies, and its se­lec­tions have come as a “sur­prise” to Wall Street...

Re­gen­eron has won the first-ever FDA ap­proval for a gene ther­a­py to treat a rare type of in­her­it­ed hear­ing loss, and the com­pa­ny plans to...

The FDA ac­cused Chemo­Cen­tryx of ma­nip­u­lat­ing the re­sults of a piv­otal clin­i­cal tri­al used to ap­prove the drug Tavneos, es­ca­lat­ing the agen­cy's ef­fort to pull...

The FDA for the first time is fac­ing phar­ma-backed crit­i­cism of its new prac­tice of pub­licly re­leas­ing par­tial­ly redact­ed drug re­jec­tion let­ters.

The law firm...

Sanofi’s tole­bru­ti­nib is on track to get an ap­proval in Eu­rope for a type of mul­ti­ple scle­ro­sis even af­ter re­ceiv­ing a com­plete re­sponse let­ter from...

No­var­tis has with­drawn its EU ap­pli­ca­tion for Plu­vic­to's ex­pan­sion in­to ear­li­er prostate can­cer treat­ment, de­spite US and UK ap­proval for the same in­di­ca­tion.

The Swiss...