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February 16, 2014
16:53 EDTJNJFDA issues CRLs for Johnson & Johnson's sNDAs for use of Xarelto
On Friday morning, Johnson & Johnson unit Janssen Research & Development announced the U.S. Food and Drug Administration issued complete response letters, CRLs, regarding supplemental New Drug Applications, sNDAs, for the use of Xarelto, rivaroxaban, an oral anticoagulant, to reduce the risk of secondary cardiovascular events -- defined as heart attack, stroke or death -- in patients with acute coronary syndrome, ACS, and to reduce the risk of stent thrombosis in the same population, in combination with standard antiplatelet therapy. "We remain committed to providing patients who have suffered from acute coronary syndrome with additional protection against stent thrombosis and secondary life-threatening cardiovascular events," said Paul Burton, M.D., Ph.D., Vice President, Clinical Development, Janssen Research & Development. "We are evaluating the contents of the letters and will determine the appropriate next steps."
News For JNJ From The Last 14 Days
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November 20, 2015
10:52 EDTJNJFDA approves new oral medication to treat multiple myeloma
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November 18, 2015
08:11 EDTJNJIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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08:11 EDTJNJAduro Biotech receives milestone payment from Janssen
Aduro Biotech (ADRO) announced that it has received a milestone payment from Janssen Biotech (JNJ) for Aduro's submission of an Investigational New Drug, or IND, Application to the FDA for ADU-741, a LADD immunotherapy product candidate for the treatment of prostate cancer. The IND will enable Janssen, Aduro's license partner for ADU-741, to initiate a multi-center Phase 1 trial to evaluate the safety and immunogenicity of intravenous administration of ADU-741 in patients with metastatic castration-resistant prostate cancer.
November 16, 2015
14:38 EDTJNJGenmab confirms FDA approval of Darzalex
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13:09 EDTJNJFDA approves Darzalex to treat multiple myeloma
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