EMD Serono, Inc, FDA Grants Priority Review To Cladribine Tablets For The Treatment Of Relapsing Forms Of MS Medical News Today Sat, 07 Aug 2010 04:05 AM PDT EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS). The application also has been granted a Priority Review designation by the FDA, which means the review period for the NDA is reduced … |
FDA Advisory Committee Unanimously Recommends Approval Of Novartis Investigational Treatment FTY720 To Treat Relapsing … Medical News Today Sat, 07 Aug 2010 04:05 AM PDT An advisory committee of the US Food and Drug Administration (FDA) recommended approval of FTY720 (fingolimod) for the treatment of patients with relapsing multiple sclerosis, the most common form of the disease. The FDA has the option of seeking the advice of one of its advisory committees as it reviews and decides whether to approve a new treatment. The committee voted unanimously that FTY720 … |
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