Drug/indication: Kalydeco for cystic fibrosis
Approval decision date: April 18, 2012
Kalydeco is the first drug to treat the underlying cause of cystic fibrosis in patients with a specific genetic defect.
Drug/indication: pixantrone for non-Hodgkin's lymphoma
Approval decision date: April 24, 2012
Cell Therapeutics appealed the FDA's 2009 decision to reject pixantrone, setting up the drug's second chance at U.S. approval.
Drug/indication: Xgeva for prevention of bone metastases from prostate cancer.
Approval decision date: April 26, 2012
Drug/indication: Avanafil for erectile dysfunction.
Approval decision date: April 29, 2012
Drug/indication: Uplyso for Gaucher's disease.
Approval decision date: May 1, 2012
FDA has twice-rejected Uplyso due to manufacturing and quality control issues and delayed a third decision from February to May. If approved this time around, Uplyso will compete against Sanofi/Genzyme's (SNY) Cerezyme and Shire's Vpriv. Talon Therapeutics (TLON)
Drug/indication: Marquibo for acute lymphoblastic leukemia (ALL)
Approval decision date: May 13, 2012 Merck (MRK) and Ariad Pharmaceuticals (ARIA)
Drug/indication: ridaforolimus for sarcoma.
Approval decision date: June 5, 2012
Ironwood Pharmaceuticals (IRWD)
Drug/indication: linaclotide for irritable bowel syndrome.
Approval decision date: June 8, 2012 Navidea Biopharmaceuticals (NAVB)
Drug/indication: Lymphoseek, a lymph node tracing agent.
Approval decision date: June 10, 2012 Amarin (AMRN)
Drug/indication: AMR101 for dyslipidemia.
Approval decision date: July 26, 2012 Horizant Pharmaceuticals (HZNT)
Drug/indication: Lodotra for rheumatoid arthritis
Approval decision date: July 26, 2012 Onyx Pharmaceuticals (ONXX)
Drug/indication: carfilzomib for multiple myeloma
Approval decision date: July 27, 2012 Sources: Company reports, TheStreet research, BioMedTracker.com --Written by Adam Feuerstein in Boston.
>To contact the writer of this article, click here: Adam Feuerstein. >To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein. >To submit a news tip, send an email to: email@example.com. Follow TheStreet on Twitter and become a fan on Facebook.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
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.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV