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FDA Calendar

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Date
Company Name
Ticker
Drug
Event
Outcome
Details
04/17/2015
Pharmacyclics Inc.
IMBRUVICA (sNDA)
FDA decision on IMBRUVICA as a treatment for patients with Waldenstrom's macroglobulinemia
04/13/2015
Pfizer Inc.
IBRANCE (NDA)
FDA decision on IBRANCE for treatment of advanced breast cancer
04/13/2015
Pfizer Inc.
Palbociclib (NDA)
FDA decision on Palbociclib as a first-line therapy in combination with Letrozole for ER+, HER2- advanced breast cancer
03/30/2015
Regeneron Pharmaceuticals
EYLEA (sBLA)
FDA decision on EYLEA for diabetic retinopathy in patients with DME
03/17/2015
Vertex Pharmaceuticals Inc.
Ivacaftor (NDA)
FDA decision on Ivacaftor in children with CF ages 2 to 5 who have G551D or one of the 8 addnl.gating mutations
03/05/2015
Pacira Pharmaceuticals, Inc.
EXPAREL (sNDA)
FDA decision on EXPAREL for femoral nerve block for total knee arthroplasty
02/28/2015
Actavis Plc.
Levosert (NDA)
FDA decision on Levosert for use by women to prevent pregnancy
02/28/2015
Salix Pharmaceuticals Ltd
XIFAXAN 550 mg tablets (sNDA)
FDA decision on XIFAXAN for treatment of irritable bowel syndrome with diarrhea
02/06/2015
Roche Holding AG
Lucentis (sBLA)
FDA decision on Lucentis for treatment of diabetic retinopathy
01/31/2015
The Medicines Co.
RAPLIXA (BLA)
FDA decision on RAPLIXA for use in hemostasis during surgery
01/30/2015
Zogenix, Inc.
Modified formulation of Zohydro ER (sNDA)
FDA decision on Modified Zohydro ER designed to have abuse deterrent properties
01/24/2015
NPS Pharmaceuticals Inc
Natpara (BLA)
FDA decision on Natpara for Hypo parathyroidism
FDA approved Natpara on Jan.23, 2015
01/24/2015
Rockwell Medical Technologies Inc
Triferic (NDA)
FDA decision on Triferic for treating iron loss in CKD patients receiving hemodialysis
FDA approved Triferic on Jan.26, 2015
01/09/2015
Impax Laboratories Inc
RYTARY (NDA)
FDA decision on RYTARY for treatment of idiopathic Parkinson's disease
FDA approved RYTARY on Jan.8, 2015
12/30/2014
Vertex Pharmaceuticals Inc.
KALYDECO (sNDA)
FDA decision on KALYDECO for use in people with cystic fibrosis ages 6 and older who have R117H mutation
FDA approves KALYDECO for use in people with cystic fibrosis ages 6 and older who have R117H mutation
Pharma-012315.jpg Novo Nordisk A/S (NVO) has received positive opinion from the European regulatory authorities for Saxenda for the treatment of obesity as an adjunct to a reduced-calorie diet and increased physical activity.
Pharma-012215.jpg InspireMD Inc. (NSPR) has been issued a notice of delisting by the NYSE MKT LLC for failure to satisfy continued listing standards of the Exchange.
Pharma-011615.jpg PharmAthene Inc. has been awarded $194.6 million plus a post-judgment interest of $30,663.89 per day by the Delaware Court of Chancery in the company's litigation against SIGA Technologies Inc.
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Everyone knows that diet and exercise are essential to keeping a healthy body. Sometimes, though, dangerous obesity requires cultural or medical intervention. Here are 3 other recent events that are helping the fight against obesity.
Prostate cancer is one of the most dreaded forms of the disease - a major problem in men's health and in the medical community generally. Recent study results released by Medivation Inc. (MDVN) and Astellas Pharma showed that a mid-stage trial of an experimental drug showed some progress. Here a few advancements (and one step back) in the battle to alleviate prostate cancer.
Older adults who suffer a bout of pneumonia could be at an increased risk for heart disease for years to come, according to a new study from researchers at the University of Pittsburgh. For the study the researchers examined health records from 6,000 people aged 65 and up who took part in the Cardiovascular Health Study and another 16,000 between 45 and 65.
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