FDA Panel Rejects Broader Use of J&J's Xarelto (Again)
A panel of FDA experts again rejected Johnson & Johnson's application to expand use of its blood thinner, Xarelto, to reduce dangerous blood clots in a new group of patients -- those with acute coronary artery disease.
Ranbaxy API Plant Given FDA Warning
Ranbaxy's API manufacturing factory in Toansa, Punjab has received a Form 483 warning from the US FDA, communicating concerns discovered during last week's inspection.
Merck Dumps Sirna RNAi Assets for $175M
Merck has agreed to sell its Sirna Therapeutics assets to Alnylam Pharmaceuticals, a leading RNAi therapeutics company, for an upfront payment of $175 million in cash and equity.