The FDA’s fo­cus on speed­ing up new clin­i­cal tri­als has spurred the open­ing of a new of­fice with­in the Cen­ter for Drug Eval­u­a­tion and Re­search...

The Cen­ters for Medicare & Med­ic­aid Ser­vices fi­nal­ized a demon­stra­tion pro­gram aimed at low­er­ing the prices of drugs in Medicare, but with sig­nif­i­cant­ly low­er ex­pect­ed...

In yet an­oth­er set­back for the Mer­ck/Dai­ichi Sankyo part­ner­ship, the com­pa­nies said they have pulled their ac­cel­er­at­ed ap­proval ap­pli­ca­tion to the FDA for an an­ti­body-drug...

The FDA ap­proved Ab­b­Vie’s tava­padon, a next-gen­er­a­tion ther­a­py for Parkin­son’s dis­ease that's ex­pect­ed to pro­vide the symp­tom re­lief of its pre­de­ces­sors but with few­er side ef­fects...

As psy­che­del­ic drugs inch clos­er to com­mer­cial­iza­tion, two House law­mak­ers are chart­ing a path for­ward for their in­evitable roll­out and what any po­ten­tial ac­com­pa­ny­ing leg­is­la­tion...

The Amer­i­can Biotech In­no­va­tion Al­liance took to Capi­tol Hill this week to tell mem­bers of Con­gress that the fight for US dom­i­nance in bio­phar­ma needs...

Egetis Ther­a­peu­tics has se­cured US ap­proval of its drug for a rare dis­ease that short­ens life ex­pectan­cy to 35 years.

The FDA on Mon­day backed...