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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
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.
Pharma-030115.jpg Amgen's Kyprolis has demonstrated superiority over Takeda's Velcade in patients with relapsed multiple myeloma in a head-to-head clinical trial.
Pharma-022615.jpg Shares of Vitae Pharmaceuticals Inc. plunged more than 22% in extended trading on Thursday after the company announced that its partner Boehringer Ingelheim has voluntarily placed BI 1181181 on a temporary clinical hold, and has notified regulatory agencies of its decision.
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A new migraine treatment that delivers painkillers via nasal spray is showing promise for migraine sufferers, according to a new study from researchers at the Albany Medical Center, in Albany, New York. The new treatment sends a dose of the anesthetic lidocaine (Xylocaine) directly to the nerves at the rear of the nasal cavity.
The majority of doctors give in to parents that request delays in child vaccinations, according to a new study from researchers at the Adult and Child Center for Health Outcomes Research and Delivery Science (ACCORDS) at the University of Colorado School of Medicine and Children's Hospital Colorado. For the study the researchers collected data from a group of 815 pediatricians.
March is Colorectal Cancer Awareness Month and researchers in the field say it's a vital tool for raising awareness about the condition. The risk of colorectal cancers increases significantly for those over the age 50 and for African-Americans over the age of 45. "Colon cancer affects both men and women from all ethnicities."
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