This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

FDA Calendar 2013

For biotech and drug companies, years of clinical trials and tens, if not hundreds, of millions of dollars in research and development culminate in a singular, all-important event: The decision by the U.S. Food and Drug Administration or its European counterparts to approve or reject a new medicine.

Investors certainly know all too well the importance of drug approval decisions on drug and biotech stocks. Next to clinical trial results, nothing drives a biotech stock higher or lower more than a U.S. or European drug approval decision.

The following calendar lists the dates of relevant FDA and European drug approval decisions, as well as FDA advisory committee meetings. The calendar will be updated regularly.

Date Company Drug Indication Expected Regulatory Event Outcome
1/21/2013 Impax Labs Rytary Parkinson's Disease FDA Approval Decision Rejection
1/28/2013 Allergan Botox - Therapeutic Overactive Bladder FDA Approval Decision Approval
1/29/2013 Sanofi and Isis Pharma Kynamro  Hypercholesterolemia FDA Approval Decision Approval
2/2/2013 Hemispherx Biopharma Ampligen Chronic Fatigue Syndrome FDA Approval Decision Rejection
2/8/2013 Celgene Pomalyst Multiple Myeloma FDA Approval Decision Approval
2/24/2013 Dynavax Technologies Heplisav Hepatitis B Vaccine FDA Approval Decision Rejection
2/26/2013 Roche and Immunogen T-DM1 HER-2 metastatic breast cancer FDA Approval Decision Approval
2/28/2013 Bayer and Onyx Pharma Stivarga Gastrointestinal stromal tumor FDA Approval Decision Approval
Now-4/23/13 Hyperion Therapeutics Ravicti Urea Cycle Disorder FDA Approval Decision Approval
3/1/2013 Zogenix Zohydro Chronic Pain FDA Approval Decision  
3/4/2013 Depomed Serada Menopause FDA Advisory Committee Meeting  
3/7/2013 GlaxoSmithKline and Theravance Breo Chronic Obstructive Pulmonary Disease FDA Advisory Committee Meeting  
3/21/2013 Titan Pharmaceuticals Probuphine Opioid Dependence FDA Advisory Committee Meeting  
3/27/2013 A.P. Pharma APF530 Chemotherapy-Induced Nausea FDA Approval Decision  
3/28/2013 Biogen Idec BG-12 Multiple Sclerosis FDA Approval Decision  
3/29/2013 United Therapeutics Oral Remodulin Pulmonary Arterial Hypertension FDA Approval Decision  
3/29/2013 Johnson & Johnson Invokana Type II Diabetes FDA Approval Decision  
Now-03/31/13 Arena Pharmaceuticals Belviq Obesity EMA CHMP Panel Result  
Now-03/31/13 Avanir Pharmaceuticals Nuedexta Pseudobulbar Affect EMA CHMP Panel Result  
4/15/2013 MAP Pharmaceuticals Levadex Migraine FDA Approval Decision  
4/26/2013 Gilead Sciences Elvitegravir HIV / AIDS FDA Approval Decision  
4/26/2013 Gilead Sciences Cobicistat HIV / AIDS FDA Approval Decision  
4/26/2013 Sucampo Pharmaceuticals Amitiza Opioid-Induced Constipation FDA Approval Decision  
4/30/2013 Titan Pharmaceuticals Probuphine Opioid Dependence FDA Approval Decision  
Now-04/30/13 Bayer and Onyx Pharma Stivarga Colorectal Cancer EMA CHMP Panel Result  
Now-04/30/13 Dendreon Provenge Prostate Cancer EMA CHMP Panel Result  
4/30/2013 Navidea Biopharmaceuticals Lymphoseek Breast Cancer Lymph Node Mapping FDA Approval Decision  
4/30/2013 Raptor Pharmaceuticals Procysbi Cystinosis FDA Approval Decision  
5/2/2013 AVEO Pharmaceuticals Tivozanib Kidney Cancer FDA Advisory Committee Meeting  
5/2/2013 Delcath Systems ChemoSat Liver mets due to melanoma FDA Advisory Committee Meeting  
5/24/2013 Valeant Pharmaceuticals Efinaconazole Toenail fungus infection FDA Approval Decision  
Now-05/31/13 Affymax Omontys Anemia in Kidney Dialysis Patients EMA CHMP Panel Result  
5/31/2013 Depomed Serada Menopause FDA Approval Decision  
Now-05/31/13 Sanofi Aubagio Multiple Sclerosis EMA CHMP Panel Result  
6/3/2013 GlaxoSmithKline Dabrafenib Melanoma FDA Approval Decision  
6/3/2013 GlaxoSmithKline Trametinib Melanoma FDA Approval Decision  
6/14/2013 Delcath Systems ChemoSat Liver mets due to melanoma FDA Approval Decision  
Now-06/30/13 AVEO Pharmaceuticals Tivopath Renal Cell Cancer FDA Advisory Committee Meeting  
Now-06/30/13 Biogen Idec BG-12 Multiple Sclerosis EMA CHMP Panel Result  
06/25/13-07/24/13 Merck Suvorexant Insomnia FDA Approval Decision  
7/26/2013 AVEO Pharmaceuticals Tivopath Renal Cell Cancer FDA Approval Decision  
7/26/2013 Forest Laboratories Levomilnacipran Depression FDA Approval Decision  
05/01/13-08/31/13 Ariad Pharmaceuticals Iclusig Acute Lymphocytic Leukemia EMA CHMP Panel Result  
02/01/13-08/31/13 Celgene Pomalyst Multiple Myeloma EMA CHMP Panel Result  
9/6/2013 Auxilium Pharmaceuticals Xiaflex Peyronie's Disease FDA Approval Decision  
10/17/2013 Antares Pharma Otrexup Rheumatoid Arthritis FDA Approval Decision  
10/22/2013 Actelion Opsumit Pulmonary Arterial Hypertension FDA Approval Decision  
10/24/2013 AMAG Pharmaceuticals Feraheme Anemia FDA Approval Decision  
12/17/2013 GlaxoSmithKline Dolutegravir HIV / AIDS FDA Approval Decision  

Sources: BioMedTracker, TheStreet research, company reports.

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Real Money
Try it NOW

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums


Chart of I:DJI
DOW 17,747.75 -50.74 -0.29%
S&P 500 2,082.19 -7.92 -0.38%
NASDAQ 5,106.7340 -20.7910 -0.41%
Top Rated Stocks Top Rated Funds Top Rated ETFs