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- November 2009
Regulatory News for November 2009
Astex Therapeutics announced recently that it has been granted orphan drug designation by the FDA for AT9283, its combinatorial oncogenic kinase inhibitor, for the treatment of patients with acute myeloid leukaemia.
24 November, 2009
The Food and Drug Administration has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia, a serious complication that can occur after a bout with shingles.
18 November, 2009
Germany's Paul-Ehrlich-Institute approves clinical trial in rheumatoid arthritis patients.
09 November, 2009
TikoMed AB announced recently that IBsolvMIR® has been granted orphan drug designation for the prevention of graft rejection during pancreatic islet transplantation by the Committee for Orphan Medicinal Products of the EMEA.
04 November, 2009
The European Medicines Agency has been formally notified by AstraZeneca of its decision to withdraw its application for a centralized marketing authorization for the medicine Zactima (vandetinib) in 100 mg film-coated tablets.
02 November, 2009