Tag:
Pradaxa
Latest Headlines
Latest Headlines
FDA review backs Xarelto for big new use in ACS patients
The anticoagulant won a thumbs-up from FDA reviewers ahead of Wednesday's advisory panel meeting, where FDA experts will weigh a lucrative new indication.
Pradaxa hits blockbuster mark, swelling Boehringer sales
The German company expects "high single digit" growth in revenues for 2012 and another leap in 2013.
Bayer gets positive ruling from NICE on Xarelto
NICE has recommended the drug for stroke and embolisms in draft guidance, and final guidance may come in April.
Pradaxa patient's death draws more scrutiny of bleeding risks
The case of a Pradaxa user who died after a minor fall is raising more questions about the drug's safety.
Pfizer, BMS face a delay on FDA's megablockbuster decision on apixaban
Pfizer ( $PFE ) and its partner Bristol-Myers Squibb ( $BMY ) will have to wait before hearing whether the FDA will sign off on marketing approval for apixaban, their blockbuster anti-clotting hopeful.
Pradaxa, Xarelto gain reprieve as FDA delays Eliquis decision
Pfizer ( $PFE ) and Bristol-Myers Squibb ( $BMY ) will have to wait three more months for the FDA's latest word on Eliquis . The anticoagulant drug has some of the strongest data among a new cadre of...
Study flags risk of heart attack, ACS in Pradaxa patients
Another blow to Pradaxa 's prospects: The Boehringer Ingelheim blood thinner has been associated with an increased risk of heart attack. In a new study, Cleveland Clinic researchers found that Pradaxa
NICE wants more data on Bayer's Xarelto
U.K. cost-effectiveness watchdogs aren't quite convinced about Bayer 's anti-clotting drug Xarelto . The National Institute for Health and Clinical Excellence says it's asking Bayer for more data on
EU brings Bayer's Xarelto into German market
Bayer has now gotten European regulators to sign off on selling its stroke prevention drug Xarelto in Germany, barely a month after the FDA approved the drug for sale in the U.S. The approval is a
FDA puts Boehringer's Pradaxa under review
Boehringer Ingelheim 's new blood thinner Pradaxa is now in the FDA's crosshairs. The U.S. regulator is reviewing reports of serious bleeding in patients using Pradaxa, the first drug approved in a
