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FDA Calendar

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Date
Company Name
Ticker
Drug
Event
Outcome
Details
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
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
Salix Pharmaceuticals Ltd
XIFAXAN (sNDA)
FDA decision on XIFAXAN he treatment of irritable bowel syndrome with diarrhea or IBS-D
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
FDA approved EYLEA for diabetic retinopathy in patients with DME on Mar.25, 2015
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
FDA panel backs BREO ELLIPTA for asthma in adults 18 years and older but is against its approval in 12-17 year olds
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
FDA panel meeting cancelled. Sugammadex to be issued complete response letter
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
FDA approved KALYDECO (Ivacaftor) for children with CF ages 2 to 5 who have specific mutations in CFTR gene on Mar.18, 2015
Pharma-032515.jpg Regeneron Pharmaceuticals Inc.'s (REGN) eye drug EYLEA has received FDA approval for yet another indication - this time, for the treatment of diabetic retinopathy in patients with diabetic macular edema.
Pharma-032415.jpg Shares of Lpath Inc. tumbled more than 25% in extended trading on Tuesday following failure of the company's phase 2a single-agent, open-label study of ASONEP to meet the primary endpoint of statistically significant progression-free survival in patients with advanced renal cell carcinoma.
Pharma-031915.jpg Prothena Corp. plc (PRTA) was up more than 40% in extended trading on Thursday after the company announced that PRX002, its investigational monoclonal antibody for the potential treatment of Parkinson's disease was safe and well-tolerated in healthy volunteers in a phase 1 single ascending dose trial, meeting the primary objective of the study.
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A newly discovered gene could hold the key to a specific form of severe autism found in some girls, according to researchers at the Johns Hopkins University School of Medicine's Institute of Genetic Medicine. The gene, called CTNND2, is central in the creation of the protein delta-catenin, which plays a large role in the nervous system.
The FDA has issued its approval on a new drug aimed at treating the inhalation of anthrax. The new drug, called Anthrasil, is an antibacterial aimed specifically at anthrax and tested well in various clinical trials on animals. No human trials were conducted. Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, released a statement about the new drug approval.
Those who live in areas with higher degrees of smog in the air could be more likely to suffer from anxiety, according to a new study from researchers at Johns Hopkins University, in Baltimore, Maryland. For the study the researchers examined health records from 70,000 women across the U.S. Women who lived in the most air-polluted urban centers in the country were more likely to suffer anxiety.
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