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FDA Calendar

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Date
Company Name
Ticker
Drug
Event
Outcome
Details
05/27/2015
Salix Pharmaceuticals Ltd
XIFAXAN (sNDA)
FDA decision on XIFAXAN he treatment of irritable bowel syndrome with diarrhea or IBS-D
05/27/2015
Salix Pharmaceuticals Ltd
XIFAXAN 550 mg tablets (sNDA)
FDA decision on XIFAXAN for treatment of irritable bowel syndrome with diarrhea
05/13/2015
KYTHERA BIOPHARMACEUTICALS INC
ATX-101 (NDA)
FDA decision on ATX-101 for improvement in the appearance of moderate to severe submental fullness
04/30/2015
THERAVANCE, INC.
BREO ELLIPTA (sNDA)
FDA decision on BREO ELLIPTA for the once-daily treatment for asthma in patients aged 12 years and older
04/30/2015
Vernalis plc
VNLPY.PK
Tuzistra (NDA)
FDA decision on Tuzistra for the treatment of cough and cold
04/29/2015
Amgen Inc.
Talimogene Laherparepvec (BLA)
FDA panel to review Talimogene Laherparepvec for the treatment of metastatic melanoma
04/17/2015
Pharmacyclics Inc.
IMBRUVICA (sNDA)
FDA decision on IMBRUVICA as a treatment for patients with Waldenstrom's macroglobulinemia
FDA approved IMBRUVICA on Jan.29, 2015
04/15/2015
The Medicines Co.
Cangrelor injection (NDA)
FDA panel to review Cangrelor for reducing thrombotic cardiovascular events including stent thrombosis
04/14/2015
Eisai Co Ltd
ESALY.PK
LENVATINIB (NDA)
FDA decision on Lenvatinib as a treatment for progressive radioiodine-refractory differentiated thyroid cancer
FDA approved Lenvatinib on Feb.16, 2015 - two months ahead of the decision date
04/13/2015
Pfizer Inc.
Ibrance (palbociclib) (NDA)
FDA decision on Ibrance for treatment of advanced breast cancer
Ibrance granted accelerated approval on Feb.3, 2015
03/30/2015
Regeneron Pharmaceuticals
EYLEA (sBLA)
FDA decision on EYLEA for diabetic retinopathy in patients with DME
03/19/2015
THERAVANCE, INC.
BREO ELLIPTA (sNDA)
FDA panel to review BREO ELLIPTA for the once-daily treatment for asthma in patients aged 12 years and older
03/18/2015
Merck & Co Inc.
Sugammadex sodium injection (NDA resubmission)
FDA panel to review Sugammadex sodium injection for the reversal of neuromuscular blockade induced by rocuronium or vecuronium
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
03/09/2015
KYTHERA BIOPHARMACEUTICALS INC
ATX-101 (NDA)
FDA panel to review ATX-101 for improvement in the appearance of moderate to severe submental fullness
Pharmacyclics-030515.jpg It's a gain of over 6,000% for investors who bought shares of Pharmacyclics Inc. (PCYC) back in February 2010 and held them all these years - a handsome reward for long-term investors.
pharmaReport-030415.jpg Cumberland Pharmaceuticals Inc. (CPIX) touched a 52-week high on Tuesday after turning around to profit in Q4 and full year 2014 on higher revenues.
Pharma-030215.jpg Intrexon Corporation (XON) was up more than 6% in extended trading after the company reported a surprise profit and better-than-expected revenue for the fourth quarter ended December 31, 2014.
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The rate of children born via in vitro fertilization, or IVF, is continuing to rise in the U.S., according to a new story from researchers at the Society for Assisted Reproductive Technology. The society collects data on IVF attempts and births across the U.S. each year and found 2,000 more success births in 2013 than the preceding year.
Game makers Ubisoft are currently developing a video game aimed at helping cure lazy eyes. The French gaming firm broke news of the new game earlier this week and confirmed they are working on it with McGill University and medical researcher firm Amblyotech Inc. One of the first games in development is called Dig Rush and has the player guiding moles that are digging their way across a screen.
A brain protein that has previously been linked with Alzheimer's disease can now be traced in younger adults, according to a new study from researchers at Northwestern University Feinberg School of Medicine in Chicago. For the study the researchers analyzed brain tissue from 13 healthy people aged 20 to 66; 14 healthy people between 70 and 99; and 21 Alzheimer's patients between 60 and 95.
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