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FDA Requires Additional Information on DORIBAX for Treatment of Hospital-Acquired Pneumonia
21.08.08 - 22:26 ... source : Johnson & Johnson
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97% | 30.07.08 - 10:40 ... source : Roche
...  rheumatoid arthritis Roche announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) by a near unanimous (10-1) vote recommended approval of Actemra (tocilizumab), a novel interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody, for reducing the signs and ...
96% | 23.07.08 - 16:50 ... source : AstraZeneca
...  a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on June 30th and validation of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for ONGLYZA™ (saxagliptin). Saxagliptin, a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor, ...
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96% | 09.07.08 - 14:22 ... source : Novo Nordisk - US
...  Nordisk Inc. and Sciele Pharma, Inc. (NASDAQ: SCRX), today announced that the U.S. Food and Drug Administration (FDA) approved PrandiMet™ (repaglinide and metformin HCl) tablets, the first and only fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin®) ...
95% | 24.06.08 - 01:59 ... source : Jerini
...  that following last week's communication with the US Food and Drug Administration (FDA), the company will submit a complete response to the FDA's not approvable letter for Icatibant in the treatment of acute attacks of hereditary angioedema (HAE). Jerini's complete ...
95% | 24.06.08 - 00:39 ... source : Jerini
...  that following last week's communication with the US Food and Drug Administration (FDA), the company will submit a complete response to the FDA's not approvable letter for Icatibant in the treatment of acute attacks of hereditary angioedema (HAE). Jerini's complete ...
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