(Reuters) - Drugs regulators on Friday approved the stroke preventer Xarelto from Bayer AG and Johnson & Johnson for people with a common heart rhythm disorder called atrial fibrillation. However, the Food and Drug Administration added a restrictive "black box" warning to the drug, warning people ...
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FDA Panel Gives Nod to Bayer/J&J Anti-Clot Drug
COLLEGE PARK, Md. – A new stroke preventer from Bayer and Johnson & Johnson moved one step closer to U.S. approval, but questions remained about restrictions on ...
FDA panel gives nod to Bayer/J&J anti-clot drug
A new stroke preventer from Bayer and Johnson & Johnson moved one step closer to U.S. approval, but questions remained about restrictions on labeling and the need for more studies.
FDA panel gives nod to Bayer/J&J anti-clot drug - Yahoo! News
Read 'FDA panel gives nod to Bayer/J&J anti-clot drug' on Yahoo! News. COLLEGE PARK, Maryland (Reuters) - A new stroke preventer from Bayer and Johnson & Johnson moved one step ...
Article > Bayer/J&J bloodthinner Xarelto gets OK from FDA
Bayer and Johnson & Johnson are celebrating after regulators in the USA finally gave a thumbs-up to their oral anticoagulant Xarelto. The US Food and Drug Administration has ...
Bayer/J&J stroke drug not ready for approval-US FDA
WASHINGTON (Reuters) - U.S. drug regulators said an experimental stroke preventer from Bayer (XETRA:BAYGN.DE - News) and Johnson & Johnson (NYSE:JNJ - News) is not ready for ...
Bayer/J&J stroke drug not ready for approval-US FDA
WASHINGTON (Reuters) - U.S. drug regulators said an experimental stroke preventer from Bayer (BAYGn.DE) and Johnson & Johnson (JNJ.N) is not ready for approval and ...
FDA Approves Xarelto® (rivaroxaban tablets) for the Prophylaxis ...
{PharmPro via BioPortfolio} Xarelto® is the only new oral anticoagulant with US approval in this indication
UPDATE 3-Bayer/J&J stroke drug not ready for approval-US FDA
WASHINGTON, Sept 6 (Reuters) - U.S. drug regulators said an experimental stroke preventer from Bayer (BAYGn.DE) and Johnson & Johnson (JNJ.N) is not ready for ...
FDA Reviewer Recommends `Complete Response` For Bayer, J&J's Xarelto
(Updates with Bayer share price in third paragraph and background in the last paragraph.) WASHINGTON -(Dow Jones)- Food and Drug Administration staff recommended against an ...
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