The FDA is plan­ning to an­nounce a slate of se­nior per­son­nel an­nounce­ments when a new com­mis­sion­er is named, in­clud­ing per­ma­nent heads of CBER and CDER...

GSK's $10.6 bil­lion ac­qui­si­tion of Nu­va­lent is de­liv­er­ing sur­pris­ing­ly ear­ly re­sults.

The FDA on Wednes­day ap­proved one of Nu­va­len­t's lung can­cer med­i­cines two months ear­li­er than...

The FDA is con­tin­u­ing to rewind ac­tions by for­mer Com­mis­sion­er Mar­ty Makary, say­ing that two med­ical jour­nal ar­ti­cles pub­lished over the last year did not...

At least 10 House law­mak­ers are back­ing a US trade pan­el’s probe of Chi­na’s biotech sec­tor and re­lat­ed pric­ing prac­tices, en­cour­ag­ing fu­ture ex­ec­u­tive ac­tion.

In...

A num­ber of mid­sized biotech com­pa­nies have met with White House and HHS of­fi­cials in the last week, pre­sent­ing their case for why two pend­ing...

As in foot­ball, so in phar­ma­ceu­ti­cals: The Eng­lish have been beat­en.

Mer­ck has out­paced As­traZeneca in the race to get the first US ap­proval for...