10/21/2013 |
AMAG Pharmaceuticals Inc. |
AVM , AMAG |
Feraheme (sNDA) |
FDA decision to expand the indication beyond treatment of iron deficiency anemia in adult patients with chronic kidney disease to adult patients with IDA who cannot take oral iron |
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10/17/2013 |
pSivida Limited |
PSDV |
ILUVIEN (NDA resubmission) |
FDA decision on ILUVIEN for treatment of chronic diabetic macular edema |
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10/16/2013 |
Amarin Corp Plc |
AMRN |
Vascepa (sNDA) |
FDA panel decision on Vascepa as an adjunct to diet in the treatment of adult patients with high triglycerides (TG =200 mg/dL and < 500 mg/dL) with mixed dyslipidemia |
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10/14/2013 |
Antares Pharma Inc. |
ATRS , AIS |
OTREXUP (NDA) |
FDA decision on OTREXUP for self-administration of methotrexate to enhance the treatment of rheumatoid arthritis (RA |
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10/03/2013 |
Ligand Pharmaceuticals Inc |
LGND |
Bazedoxifene/Conjugated estrogens or BZA/CE (NDA) |
FDA decision on BZA/CE for symptoms associated with menopause and prevention of osteoporosis |
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09/21/2013 |
Celgene Corporation |
CELG |
ABRAXANE (sBLA) |
FDA decision on ABRAXANE for the first–line treatment of patients with advanced pancreatic cance |
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09/14/2013 |
Seattle Genetics Inc. |
SGEN |
ADCETRIS (sBLA) |
FDA decision on ADCETRIS for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma |
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09/13/2013 |
Delcath Systems Inc. |
DCTH |
Melblez Kit (NDA) |
FDA decision on Melblez Kit for the treatment of patients with unresectable ocular melanoma metastatic to the liver |
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09/03/2013 |
GlaxoSmithKline PLC |
GSK.L, GSK |
Trametinib (NDA) |
FDA decision on Trametinib as a treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutations |
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09/01/2013 |
Otsuka Holdings Co., Ltd. |
OTSKF.PK |
Tolvaptan (NDA) |
FDA decision on Tolvaptan for the treatment of autosomal dominant polycystic kidney disease |
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08/26/2013 |
QRX PHARMA |
QRXPY.PK, QRX.AX |
MOXDUO (Resubmitted NDA) |
FDA decision on MOXDUO for the treatment of acute pain |
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08/06/2013 |
Bayer AG |
BAYZF.PK, BAYRY.PK, BYR.L |
Adempas (NDA) |
FDA panel to review Adempas for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension |
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07/28/2013 |
AVEO Pharmaceuticals, Inc. |
AVEO |
TIVOPATH aka Tivozanib (NDA) |
FDA decision on TIVOPATH for advanced renal cell carcinoma |
FDA issued Complete Response Letter for Tivozanib on June 10, 2013 |
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07/23/2013 |
AbbVie |
ABBV |
HUMIRA (sBLA) |
FDA panel to review HUMIRA injection, for addnl indication of reducing signs and symptoms in adult patients with active non-radiographic axial spondyloarthritis |
FDA panel voted 12 to 1 against recommending HUMIRA for treating adult patients with active non-radiographic axial spondyloarthritis |
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07/18/2013 |
Merck & Co Inc. |
MRK |
Sugammadex sodium injection (NDA) |
FDA panel to review Sugammadex sodium for the proposed indications of routine reversal of moderate and deep neuromuscular blockade |
FDA panel meeting cancelled as the agency has sought additional time to assess the results of recently completed inspection of a clinical trial site |
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