Regulation - Pharmaceutical, Janssen Pharmaceutica

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Janssen submits NDA for "breakthrough" leukemia and lymphoma drug ibrutinib

11-07-2013

Janssen Pharmaceuticals, a unit of US health care giant Johnson & Johnson (NYSE: JNJ), has submitted…

ibrutinibJanssen PharmaceuticaJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulation

US FDA clears Bayer/Johnson & Johnson’s Xarelto for stroke risk reduction in AF patients

07-11-2011

In what was much-awaited good news for German drug major Bayer (BAY: DE), its US subsidiary announced…

BayerCardio-vascularJanssen PharmaceuticaJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

Johnson & Johnson’s telaprevir approved in Europe for genotype-1 chronic hepatitis C

21-09-2011

The European Commission has approved Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Incivo (telaprevir),…

Anti-viralsEuropeIncivekIncivoJanssen PharmaceuticaJohnson & JohnsonPharmaceuticalRegulationtelaprivirVertex

Janssen Biotech gets FDA delay for new Simponi indication

12-09-2011

The US Food and Drug Administration has issued a Complete Response letter (CRL) to Janssen Biotech, a…

Anti-Arthritics/RheumaticsBiotechnologyJanssen PharmaceuticaJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSimponi Injection

US FDA advisory panel backs approval of Bayer/J&J’s Xarelto for stroke prevention

09-09-2011

There must have been a palpable sigh of relief last night across Leverkusen, the headquarters of Germany’s…

BayerCardio-vascularJanssen PharmaceuticaJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

Johnson & Johnson’s Nucynta OKed by US FDA for moderate to severe chronic pain

30-08-2011

US health care giant Johnson & Johnson (NYSE: JN) group company Janssen Pharmaceuticals says that the…

GrunenthalJanssen PharmaceuticaJohnson & JohnsonNeurologicalNorth AmericaNucyntaPharmaceuticalRegulationtapentadol

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