logo

FDA Calendar

Get in-depth analysis and insight on investing in the high-stakes biotech and pharma sectors. Check out our
premium biotech research product and our biotech home page.
Date
Company Name
Ticker
Drug
Event
Outcome
Details
08/22/2015
Alkermes plc
Aripiprazole Lauroxil (NDA)
FDA decision on Aripiprazole Lauroxil for the treatment of schizophrenia
08/22/2015
Alkermes plc
Aripiprazole lauroxil (NDA)
FDA decision on Aripiprazole lauroxil for the treatment of schizophrenia
08/11/2015
EXELIXIS INC
Cobimetinib (NDA)
FDA decision on Cobimetinib for treatment of patients with BRAF V600 mutation-positive advanced melanoma
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 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
06/10/2015
Amgen Inc.
Repatha (BLA)
FDA panel to review Repatha for treatment of high cholesterol
06/09/2015
Sanofi
Praluent (BLA)
FDA panel to review Praluent for the treatment of patients with high cholesterol
06/09/2015
Regeneron Pharmaceuticals
Praluent (BLA)
FDA panel to review Praluent for the treatment of patients with high cholesterol
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
FDA approved Blinatumomab under brand name Blincyto on Dec.3, 2014
05/18/2015
Johnson & Johnson
Three-Month Paliperidone Palmitate (NDA)
FDA decision on Three-Month Paliperidone Palmitate for the treatment of schizophrenia
FDA approved 3-month Paliperidone Palmitate under brand name Invega Trinza on May 19, 2015
PharmaReport-052215.jpg Shares of Otonomy Inc. (OTIC) were down more than 18% in extended trading on Thursday after the company announced that its phase IIb trial of OTO-104 in patients with unilateral Ménière's disease narrowly missed achieving statistical significance.
Pharma-052115.jpg Shares of IsoRay Inc. (ISR) skyrocketed more than 90% on Wednesday, following an on-line publication of the first major peer reviewed study, which revealed improved results of the company's Cesium-131 seeds in the treatment of lung cancer.
Sarepta-052015.jpg Shares of Sarepta Therapeutics Inc. (SRPT) are up in pre-market trading on Wednesday as investors welcome the news of the company's progress made in the NDA submission for Eteplirsen.
More
Many freshman female students have experienced at least some type of rape, according to a new study. The study, published in the Journal of Adolescent Health, looked at 483 women who were a representative sample of the freshman class and who volunteered to partake in the study. The women filled out questionnaires when they arrived on campus and at the end of their fall semester.
Habitual marijuana use may cause early puberty and stunt growth amongst teenage boys, according to a new study from researchers at the Agriculture University Rawalpindi in Pakistan. For the study the researchers collected health data from 220 non-smoking and 217 cannabis-addicted boys. They found elevated levels of puberty hormones like testosterone and luteinising hormone among the smokers.
Pregnant women should limit the use of paracetamol, as long-term use of the painkiller could affect the reproductive health of their sons, a new study suggests. For the study, published in the journal Science Translational Medicine, scientists engineered a system to mimic the conditions of human pregnancy as closely as possible.
More
comments powered by Disqus