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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
Vernalis plc
VNLPY.PK
Tuzistra (NDA)
FDA decision on Tuzistra for the treatment of cough and cold
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
04/29/2015
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-040115.jpg Shares of Dyax Corp. (DYAX) were up more than 49% in extended trading on Tuesday, following positive results from the company's phase 1b clinical trial of DX-2930, which is being developed for the prevention of hereditary angioedema attacks.
HPTX-ASPX-033115.jpg It was a "Merger Monday" for the biotech sector yesterday, with two blockbuster acquisitions being announced.
Pharma-033015.jpg It was a Merger Monday for the Biotech sector - with two deals being announced. Horizon Pharma plc (HZNP) is all set to acquire Hyperion Therapeutics Inc. (HPTX) for $46.00 per share or $1.1 billion in cash. Another deal of the day is the acquisition of Auspex Pharmaceuticals, Inc. (ASPX) by Teva Pharmaceutical Industries Ltd. (TEVA) for $101.00 per share in cash.
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A new form of MRI technology that can detect sugar may help improve cancer detection and decrease the need for invasive procedures, according to a new study from researchers at Johns Hopkins. The new technology images not only uncover the proteins in potential tumors, but also the glucose surrounding those tumors to create more defined images.
Many parents struggle to accurately determine if their child is obese, according to a new study from researchers at the London School of Hygiene & Tropical Medicine. For the study the researchers surveyed 2,976 parents and compared their responses to health records collected about their kids. They found that 33 percent of parents underestimated their children's weight.
The overall fast food consumption of U.S. kids may be decreasing, according to a new study from researchers at Tufts University in Medford, Massachusetts. For the study the researchers compared data collected as part of the National Health and Nutrition Examination Surveys. They found that in the 2003 survey, roughly 39 percent of kids in the U.S. reported eating fast food at least once a day.
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