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FDA Calendar

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Date
Company Name
Ticker
Drug
Event
Outcome
Details
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
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
FDA panel recommends approval of 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
Pharma-040915.jpg Shares of TrovaGene Inc. surged more than 20% on Friday on news that the company's urine-based Precision Cancer Monitoring, or PCM, platform outperformed tissue biopsy for the detection and monitoring of EGFR T790M mutations in metastatic lung cancer patients.
Pharma-041615.jpg Shares of MediciNova Inc. (MNOV) surged more than 41% on Thursday, following receipt of FDA's Fast Track designation for the company's phase II-ready compound - MN-001 - for the treatment of patients with nonalcoholic steatohepatitis with fibrosis.
Pharma-041515.jpg Shares of Celsion Corp. (CLSN) rose more than 18% on Wednesday following positive interim data from the company's ongoing open-label phase 2 trial of ThermoDox in recurrent chest wall breast cancer.
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The FDA has announced plans for two days of hearings to review safety claims of homeopathic remedies. In recent years the agency has issued warnings to as many as 40 different homeopathic remedy makers warning them against claims for potential health benefits of their products. Health reporter Dr. Holly Phillips commented on the issue with "CBS This Morning" earlier this week.
A new pair of clinical trials suggest that immune system drugs can help treat advanced melanoma. In the studies, researchers found that the immune checkpoint inhibitor Keytruda worked better than the current frontline treatment for melanoma, Yervoy. They also found that using both drugs together yielded better results than using Yervoy alone.
A new form of blood test called a liquid biopsy could prove more effective than traditional biopsies, according to a new study from researchers at the Memorial Sloan Kettering Cancer Center. With the new blood test doctors can seek out tiny fragments of DNA that are shed by tumor cells in the blood stream.
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