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FDA Calendar

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Date
Company Name
Ticker
Drug
Event
Outcome
Details
07/26/2015
Amgen Inc.
Kyprolis (sNDA)
FDA decision on Kyprolis for the treatment of relapsed multiple myeloma
07/24/2015
Regeneron Pharmaceuticals
Praluent (BLA)
FDA decision on Praluent for the treatment of hypercholesterolemia
07/24/2015
Regeneron Pharmaceuticals
Praluent (BLA)
FDA decision on Praluent for the treatment of patients with hypercholesterolemia
07/05/2015
Vertex Pharmaceuticals Inc.
Lumacaftor / Ivacaftor combo
FDA decision on Lumacaftor / Ivacaftor combo in people with CF ages 12 and older who have two copies of the F508del mutation
06/22/2015
Bristol-Myers Squibb Co.
Opdivo (BLA)
FDA decision on Opdivo for the treatment of patients with advanced squamous non-small cell lung cancer after prior therapy
FDA approved Opdivo on Mar.4, 2015
05/27/2015
Salix Pharmaceuticals Ltd
XIFAXAN 550 mg tablets (sNDA)
FDA decision on XIFAXAN for treatment of irritable bowel syndrome with diarrhea
05/27/2015
Amgen Inc.
Corlanor (NDA)
FDA decision on Corlanor to treat heart failure
FDA approved Corlanor on April 15, 2015
05/27/2015
Salix Pharmaceuticals Ltd
XIFAXAN (sNDA)
FDA decision on XIFAXAN he treatment of irritable bowel syndrome with diarrhea or IBS-D
05/19/2015
Amgen Inc.
Blinatumomab (BLA)
FDA decision on Blinatumomab for acute lymphoblastic leukemia
05/18/2015
Johnson & Johnson
Three-Month Paliperidone Palmitate (NDA)
FDA decision on Three-Month Paliperidone Palmitate for the treatment of schizophrenia
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
05/12/2015
Vertex Pharmaceuticals Inc.
Lumacaftor/Ivacaftor combo (NDA)
FDA panel to review Lumacaftor / Ivacaftor combo for treating people with CF ages 12 and older who have two copies of the F508del mutation
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
Pharma-042615.jpg CryoLife Inc. (CRY) has resolved the FDA warning letter that was issued to the company in January 2013 related to its manufacturing facility and headquarters in Kennesaw, GA.
Pharma-041315.jpg Shares of Akorn Inc. were down more than 13% in after-hours trading on Friday after the company announced that it will restate its previously issued financial statements for the annual period ending December 31, 2014 and the quarterly periods ending June 30, 2014, September 30, 2014 and December 31, 2014 due to errors identified during the first quarter 2015 financial review process.
Pharma-042315.jpg Aerie Pharmaceuticals Inc. (AERI) plunged more than 65% in after-hours on Thursday as its first phase 3 registration trial of glaucoma treatment, Rhopressa, dubbed Rocket-1, failed to meet the primary endpoint.
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New York State Attorney General Eric T. Scheiderman has filed suits against two indoor tanning facilities claiming that there is "nothing safe" about their services. The suits came down against Portofino Spas and Total Tan and he also plans to file suit against Beach Bum Tanning and Planet Fitness. "Make no mistake about it: There is nothing safe about indoor tanning."
Jeni's Splendid Ice Cream has recalled its entire product line due to the ongoing listeria scare. The move comes after a random sample testing by the Nebraska Department of Agriculture turned up positive for the potentially deadly contaminate. Jeni's is the second national ice cream producer to recall its product line this month and follows Blue Ice Cream, which pulled its products last week.
Leading ADHD drugs like Adderall often increase productivity but could also pose some health risks, according to a new study from researchers at the National Institute on Drug Abuse (NIDA). When used improperly these drugs can lead to drug-addiction, irregular heartbeat, and hallucinations and they've become more popular with teens and adults in recent years.
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