03/28/2012 Chelsea Therapeutics International CHTP Northera (NDA) FDA decision on Northera for treatment of symptomatic neurogenic orthostatic hypotension
03/27/2012 AFFYMAX INC AFFY Peginesatide (formerly known as Hematide) (NDA) FDA decision on Peginesatide for anemia associated with CKD patients on dialysis
03/26/2012 MAP PHARMACEUTICALS, MAPP Levadex NDA FDA decision on Levadex as a potential acute treatment of migraine in adults
03/21/2012 Talon Therapeutics, Inc. TLON.OB Marqibo (NDA) FDA panel to review Marqibo for the proposed treatment of adult Philadelphia chromosomenegative acute lymphoblastic leukemia
03/20/2012 GlaxoSmithKline PLC GSK, GSK.L Votrient (sNDA) FDA panel to review Votrient in addnl indication as treatment for advanced soft tissue sarcoma
03/20/2012 Ariad Pharmaceuticals Inc ARIA Taltorvic (ridaforolimus) (NDA) FDA panel to review Taltorvic for adult and pediatric patients with metastatic soft tissue sarcoma
03/08/2012 Curis Inc CRIS Vismodegib (NDA) FDA decision on Erivedge (Vismodegib) for treatment of advanced Basal Cell Carcinoma
03/07/2012 NeurogesX Inc NGSX Qutenza (sNDA) FDA decision on Qutenza in addnl indication for neuropathic pain associated with HIVassociated peripheral neuropathy
03/06/2012 Discovery Laboratories Inc DSCO Surfaxin (NDA Resubmission) FDA decision on Surfaxin for prevention of respiratory distress syndrome in premature infants
03/06/2012 Astex Pharmaceuticals, Inc. SUPG, ASTX Dacogen(sNDA) FDA decision on Dacogen in addnl. indication of elderly Acute Myeloid Leukemia
02/26/2012 Columbia Laboratories Inc CBRX PROCHIEVE (NDA) FDA decision on PROCHIEVE for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy
02/17/2012 Corcept Therapeutics Inc CORT Corlux (NDA) FDA decision on Corlux for treating Cushing’s Syndrome
02/01/2012 PROTALIX BIOTHERAPEUTICS PLX Taliglucerase Alfa (NDA resubmission) FDA decision on Taliglucerase Alfa for treatment of Gaucher disease
01/28/2012 Bristol-Myers Squibb Co. BMY Dapagliflozin (NDA) FDA decision on Dapagliflozin as a proposed treatment of adults with type 2 diabetes mellitus
01/20/2012 Columbia Laboratories Inc CBRX PROCHIEVE (NDA) FDA panel to review PROCHIEVE for reduction of risk of preterm birth
12/20/2011 Eli Lilly And Co. LLY Florbetapir F 18 injection (NDA) FDA panel review of Florbetapir for use in positron emission tomography imaging of beta-amyloid) aggregates in brain to help rule out Alzheimer's disease
12/12/2011 Alexza Pharmaceuticals Inc. ALXA ADASUVE (NDA resubmission) FDA panel to review ADASUVE for schizophrenia or bipolar disorder
12/08/2011 Antares Pharma Inc. AIS Anturol Gel (NDA) FDA decision on Anturol Gel for overactive bladder
12/07/2011 AFFYMAX INC AFFY Peginesatide (NDA) FDA panel to review Peginesatide for anemia associated with chronic renal failure
12/07/2011 Pfizer Inc. PFE INLYTA (NDA) FDA panel to review INLYTA for treatment of kidney cancer
12/03/2011 Incyte Corporation INCY Ruxolitinib (NDA) FDA approved Ruxolitinib, which will be sold as Jakafi, for treatment of myelofibrosis on Nov.16
11/14/2011 biosante pharmaceuticals inc. BPAX Bio-T-Gel (NDA) FDA decision on Bio-T-Gel extended to February 14, 2012
11/14/2011 Teva Pharmaceutical Industries Limited TEVA Bio-T-Gel (NDA) FDA decision on Bio-T-Gel extended to Feb.14, 2012
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