Pradaxa

The approval comes after the drug developers had been stiff-armed twice by the FDA, which has now set a March 17, 2013 PDUFA date on the therapy.

Rack up another set of new uses for Bayer's Xarelto. The anticoagulant won European approval to treat and prevent pulmonary embolism and to prevent deep vein thrombosis. It's the first warfarin-alternative drug to win these indications, giving it an edge over its rival Pradaxa.

Boehringer Ingelheim has recalled a lot of its blood thinner Pradaxa 75 mg because of potential problems with bottles that may have affected the drug's quality.

Just days after the FDA said it had found that rates of gastrointestinal or intracranial bleeding were no more prevalent for patients taking the blood thinner Pradaxa than for those taking the old school warfarin, developer Boehringer Ingelheim released some long-term study results backing up that finding and potentially the drug's lead in the marketplace.

FDA has sifted the data on Pradaxa, the blood thinner that's attracted some controversy of late. And despite an onslaught of adverse-event reports--and hundreds of deaths--the agency says rates of gastrointestinal bleeding and intracranial hemorrhage were no higher in Pradaxa patients than in those using the older drug it was designed to replace.

With respiratory drugs helping to fuel its earnings and new ones in the pipeline, Boehringer Ingelheim is again upping capacity for its Respimat Soft inhalers that the FDA last year approved for use.