The FDA on Fri­day post­ed 14 new re­jec­tion let­ters to phar­ma com­pa­nies on­line, days af­ter HHS con­firmed to End­points Newsthat the agency had paused...

The FDA's drug cen­ter hired more new em­ploy­ees than it lost in a quar­ter for the first time since the Trump ad­min­is­tra­tion gut­ted the agen­cy's...

Af­ter set­ting the in­dus­try ablaze last month, a bi­par­ti­san bill aimed at re­strict­ing US biotech com­pa­nies from strik­ing deals with Chi­nese coun­ter­parts is in lim­bo...

The FDA is propos­ing a rule to change how fac­to­ries are reg­is­tered with the agency if they are mak­ing prod­ucts for the US mar­ket, as...

The FDA has fi­nal­ized clin­i­cal guid­ance for psy­che­del­ic drug de­vel­op­ers and has sched­uled a pub­lic hear­ing on fu­ture ther­a­peu­tic use, adding reg­u­la­to­ry mo­men­tum to a...

The FDA has chas­tised Lund­beck Seat­tle Bio­phar­ma­ceu­ti­cals for two pro­mo­tion­al web­pages that made al­leged­ly in­flat­ed claims re­gard­ing the ef­fi­ca­cy of its mi­graine drug.

In an ...