FDA Calendar

DateCompany NameTickerDrugEventOutcomeDetails
12/30/2014POZEN Inc. POZN PA8140/PA32540 (NDA resubmission)FDA decision on PA8140/PA32540 secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
12/05/2014Incyte Corporation INCY Ruxolitinib (sNDA)FDA decision on Ruxolitinib as a potential treatment in the addnl. indication of polycythemia vera patients who have had an inadequate response to or are intolerant of hydroxyurea
-Approved in Other Countries

11/26/2014Avanir Pharmaceuticals AVNR AVP-825 (NDA)FDA decision on AVP-825 for the acute treatment of migraine.
-Drug Status

11/05/2014AEterna Zentaris Inc AEZ.TO, AEZS Macimorelin Acetate (NDA)FDA decision on Macimorelin Acetate in treating in Adult Growth Hormone Deficiency
10/28/2014Merck & Co Inc. MRK MK-3475 (BLA)FDA decision on MK-3475 for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab FDA approved Keytruda (formerly known as MK-3475) for the treatment of melanoma patients who have not responded to prior therapies on Sep.4, 2014
-Drug Status

10/24/2014Roche Holding AG RHHBY Avastin (sBLA)FDA decision on Avastin plus chemotherapy for the treatment of women with persistent, recurrent or metastaticcervical cancer
10/24/2014NPS Pharmaceuticals Inc NPSP Natpara (BLA)FDA decision on Natpara for the treatment of hypoparathyroidism
10/23/2014Regeneron Pharmaceuticals REGN EYLEA (sBLA)FDA decision on EYLEA for the expanded indication of of Macular Edema following Branch Retinal Vein Occlusion
-Approved in Other Countries

10/20/2014Auxilium Pharmaceuticals Inc. AUXL XIAFLEX (sBLA) FDA decision on XIAFLEX for the treatment of two Dupuytren's contracture (DC) cords concurrently
10/20/2014Novartis AG NVS Secukinumab (BLA)FDA panel to review Secukinumab for the proposed treatment of moderate to severe plaque psoriasis
10/16/2014Pfizer Inc. PFE CHANTIX FDA panel to discuss the risk of serious neuropsychiatric adverse events
10/10/2014Gilead Sciences Inc. GILD Ledipasvir/Sofosbuvir (NDA)FDA decision on Ledipasvir/Sofosbuvir for chronic hepatitis C genotype 1 infection
10/07/2014Pharmacyclics Inc. PCYC IMBRUVICA (sNDA)FDA decision on IMBRUVICA in the treatment of patients with chronic lymphocytic leukemia and small lymphocytic lymphoma who have received at least one prior therapy for a full approval.
10/04/2014Gilead Sciences Inc. GILD Elvitegravir (NDA resubmission) FDA decision on Elvitegravir or the treatment of HIV-1 infection in treatment-experienced adults
-Approved in Other Countries

10/03/2014Gilead Sciences Inc. GILD Cobicistat (NDA resubmission)FDA decision on Cobicistat as a boosting agent for HIV therapy
-Approved in Other Countries

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