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Sunday, December 02, 2012 10:22:19 AM
December FDA plays
>>> Link back for November plays
12/07/2012 Zogenix, Inc. ZGNX Zohydro ER (NDA)
FDA panel to review Zohydro ER for management of chronic pain
12/15/2012 GlaxoSmithKline PLC GSK, GSK.L Raxibacumab (BLA resubmission)
FDA decision on Raxibacumab for treating inhalational anthrax
-Approved in Other Countries. Raxibacumab BLA was resubmitted by Human Genome Sciences, which was acquired by GlaxoSmithKline in July of 2012.
Human Genome Says FDA Acknowledges Receipt Of Resubmission Of Raxibacumab BLA
12/20/2012 Hemispherx Biopharma, Inc. HEB Ampligen (NDA)
FDA panel to review Ampligen for Chronic Fatigue Syndrome
12/21/2012 Alexza Pharmaceuticals Inc. ALXA ADASUVE (NDA resubmission)
FDA decision on ADASUVE for proposed treatment of agitation associated with schizophrenia or bipolar I disorder in adults. In May of 2012, FDA refused to approve ADASUVE due to manufacturing deficiencies at the company's Mountain View, California facility. The compay resbmitted the ADASUVE NDA on June 22, 2012.
12/28/2012 Biogen Idec BIIB BG-12 (dimethyl fumarate) (NDA)
FDA decision on BG-12 for treatment of multiple sclerosis Extended by three months to March 28, 2013
12/29/2012 Johnson & Johnson JNJ Bedaquiline (NDA filed by Jannsen Therapeutics, a part of JNJ)
FDA decision on Bedaquiline for treatment of patients with multi-drug resistant pulmonary tuberculosis. FDA Panel Recommends Accelerated Approval Of Janssen's Tuberculosis Drug
12/30/2012 NPS Pharmaceuticals Inc NPSP Gattex (NDA)
FDA decision on Gattex for treatment of short bowel syndrome in adults. On Oct.16, Gattex was unanimously backed by an FDA panel as treatment for adults with short bowel syndrome
>>> Link back for November plays
12/07/2012 Zogenix, Inc. ZGNX Zohydro ER (NDA)
FDA panel to review Zohydro ER for management of chronic pain
12/15/2012 GlaxoSmithKline PLC GSK, GSK.L Raxibacumab (BLA resubmission)
FDA decision on Raxibacumab for treating inhalational anthrax
-Approved in Other Countries. Raxibacumab BLA was resubmitted by Human Genome Sciences, which was acquired by GlaxoSmithKline in July of 2012.
Human Genome Says FDA Acknowledges Receipt Of Resubmission Of Raxibacumab BLA
12/20/2012 Hemispherx Biopharma, Inc. HEB Ampligen (NDA)
FDA panel to review Ampligen for Chronic Fatigue Syndrome
12/21/2012 Alexza Pharmaceuticals Inc. ALXA ADASUVE (NDA resubmission)
FDA decision on ADASUVE for proposed treatment of agitation associated with schizophrenia or bipolar I disorder in adults. In May of 2012, FDA refused to approve ADASUVE due to manufacturing deficiencies at the company's Mountain View, California facility. The compay resbmitted the ADASUVE NDA on June 22, 2012.
12/28/2012 Biogen Idec BIIB BG-12 (dimethyl fumarate) (NDA)
FDA decision on BG-12 for treatment of multiple sclerosis Extended by three months to March 28, 2013
12/29/2012 Johnson & Johnson JNJ Bedaquiline (NDA filed by Jannsen Therapeutics, a part of JNJ)
FDA decision on Bedaquiline for treatment of patients with multi-drug resistant pulmonary tuberculosis. FDA Panel Recommends Accelerated Approval Of Janssen's Tuberculosis Drug
12/30/2012 NPS Pharmaceuticals Inc NPSP Gattex (NDA)
FDA decision on Gattex for treatment of short bowel syndrome in adults. On Oct.16, Gattex was unanimously backed by an FDA panel as treatment for adults with short bowel syndrome
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