WuXi AppTec has filed for a pre­lim­i­nary in­junc­tion to sus­pend its place on the Pen­ta­gon’s list of com­pa­nies with al­leged ties to the Chi­nese mil­i­tary.

The...

More than 200 bio­phar­ma in­vestors and firms have signed an open let­ter call­ing for Eu­ro­pean gov­ern­ments to im­prove Eu­rope’s life sci­ences sec­tor.

The Fri­day let­ter...

A con­gres­sion­al com­mit­tee has opened an in­quiry in­to Bris­tol My­ers Squibb and Pfiz­er's use of clin­i­cal tri­al sites in Chi­na, in­clud­ing fa­cil­i­ties that the com­mit­tee's...

An FDA warn­ing let­ter sent late last month to Gen­zyme's Ire­land-based man­u­fac­tur­ing site, now owned by Sanofi, rais­es sig­nif­i­cant qual­i­ty- and da­ta-re­lat­ed is­sues.

On da­ta...

The FDA has cho­sen the first sev­en com­pa­nies to par­tic­i­pate in its PreCheck pi­lot pro­gram, a group that in­cludes large drug­mak­ers Eli Lil­ly and Re­gen­eron...

Uni­cy­cive Ther­a­peu­tics’ chron­ic kid­ney dis­ease drug was re­ject­ed by the FDA for a sec­ond time over per­sis­tent is­sues at a third-par­ty con­tract man­u­fac­tur­er.

The com­pa­ny’s...

The FDA has is­sued So­bi, al­so known as Swedish Or­phan Biovit­rum, a com­plete re­sponse let­ter for its com­bi­na­tion gout treat­ment over pro­duc­tion con­cerns and is­sues...