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Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

14-02-2014

There was further negative news for Germany’s Bayer and partner US health care giant Johnson & Johnson,…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

17-01-2014

The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted against…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

Setback for Janssen and Bayer's Xarelto as FDA calls for more info in stent thrombosis setting for ACS patients

01-07-2013

Janssen Research & Development, a unit of US health care giant Johnson & Johnson (NYSE: JNJ) revealed…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

FDA expands Bayer/Janssen's Xarelto use to treat, reduce recurrence of blood clots

05-11-2012

The US Food and Drug Administration (FDA) late Friday approved German drug major Bayer's (BAYN: DE) oral…

BayerBiotechnologyCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

Janssen responds to FDA's Xarelto CRL; resubmits sNDA

10-09-2012

Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Research & Development, German drug major Bayer's (BAYN:…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

US priority review for two Xarelto sNDAs; one dropped

10-07-2012

The US Food and Drug Administration has assigned a priority review designation to the supplemental New…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

News briefs on Janssen, Bayer and Merck KGaA/Threshold

12-04-2012

In the USA, the Arkansas jury found that the Janssen unit of US health care giant Johnson & Johnson (NYSE:…

BayerFinancialJanssenJohnson & JohnsonLegalMerck KGaAPharmaceuticalRegulationRisperdalThreshold PharmaceuticalsXarelto

Strong results for Bayer's Xarelto in treating pulmonary blood clots

27-03-2012

German drugs and crops sciences group Bayer (BAY: DE), and partner Janssen, part of US health care major…

BayerCardio-vascularJanssenJohnson & JohnsonPharmaceuticalRegulationResearchRespiratory and PulmonaryXarelto

Bayer and J&J’s Xarelto gets US Priority Review for new indication

29-02-2012

The US Food and Drug Administration has granted Priority Review designation to the supplemental New Drug…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

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