Biogen Idec ( BIIB) and Elan ( ELN) Drug/indication:Update to the Tysabri prescribing label Approval decision date: Jan. 20, 2012 The Tysabri label update will include information about the anti-JC virus antibody status as a factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML). Doctors can use to test to determine which multiple sclerosis patients are at low or high risk for PML, a serious, potentially fatal brain infection caused by Tysabri. Columbia Labs ( CBRX) and Watson Pharmaceuticals ( WPI) Drug/indication:progesterone vaginal gel for risk reduction of preterm birth. FDA advisory panel: Jan. 20, 2012 Approval decision date:Feb. 26, 2012 Amylin Pharmaceuticals ( AMLN) Drug/indication: Bydureon for diabetes Approval decision date: Jan. 27, 2012 This is the second shot at approval for Bydureon, a once-weekly injectable medicine for the treatment of Type 2 diabetes. Amylin recently split with its long-time marketing partner Eli Lilly ( LLY). Alkermes ( ALKS) retains its royalty split on Bydureon sales. Bristol-Myers Squibb ( BMY) Drug/indication: dapagliflozin for diabetes Approval decision date: Jan. 27, 2012 Pfizer ( PFE) and Protalix Biotherapeutics ( PLX) Drug/indication: Uplyso for Gaucher's disease. Approval decision date: Feb. 1, 2012 FDA has twice-rejected Uplyso due to manufacturing and quality control issues. If approved this time around, Uplyso will compete against Sanofi/Genzyme's ( SNY) Cerezyme and Shire's Vpriv. Teva ( TEVA) and BioSante Pharmaceuticals ( BPAX) Drug/indication: Bio-T-Gel for hypogonadism Approval decision date: Feb. 14, 2012 Bio-T-Gel is a once-daily gel used to treat low testosterone in men. Corcept Pharmaceuticals ( CORT) Drug/indication: Corlux for Cushing's Syndrome. Approval decision date: Feb. 17, 2012 FDA will not convene an advisory panel to review Corlux. Discovery Labs ( DSCO) Drug/indication: Surfaxin for respiratory distress syndrome in premature infants. Approval decision date: March 6, 2012 This is Discovery's fifth attempt at convincing FDA to approve Surfaxin. Roche ( RHHBY) and Curis ( CRIS) Drug/indication: Vismodegib for advanced basal cell carcinoma. Approval decision date: March 8, 2012. MAP Pharmaceuticals ( MAPP) Drug/indication: Levadex for migraines Approval decision date: March 26, 2012 Levadex is an inhaled migraine drug. FDA has not yet announced whether it intends to hold an advisory panel to review Levadex. Chelsea Therapeutics ( CHTP) Drug/indication: Northera for orthostatic hypotension Approval decision date: March 28, 2012 Pfizer ( PFE) and Bristol-Myers Squibb ( BMY) Drug/indication: Eliquis for prevention of stroke and blood clots in patients with atrial fibrilation. Approval decision date: March 28, 2012 Onyx Pharmaceuticals ( ONXX) Drug/indication: Carfilzomib for multiple myeloma Approval decision date: March 28, 2012 (estimated, not confirmed, based on Sept. 28, 2011 filing date. FDA accepted the carfilzomib filing on Nov. 28 but has not yet set a specific approval decision date. I'm assuming a six-month priority review because carfilzomib is a cancer drug. Vivus ( VVUS) Drug/indication: Qnexa for obesity Approval decision date: April 17, 2012 FDA rejected Qnexa initially in 2010 due to safety concerns. Vertex Pharmaceuticals ( VRTX) Drug/indication: Kalydeco for cystic fibrosis Approval decision date: April 19, 2012 Kalydeco is the first drug to treat the underlying cause of cystic fibrosis in patients with a specific genetic defect. Cell Therapeutics ( CTIC) Drug/indication: pixantrone for non-Hodgkin's lymphoma Approval decision date: April 2012 (Specific date unknown.) Cell Therapeutics appealed the FDA's 2009 decision to reject pixantrone, setting up the drug's second chance at U.S. approval. Amgen ( AMGN) Drug/indication: Xgeva for prevention of bone metastases from prostate cancer. Approval decision date: April 26, 2012 VVUS ( VVUS) Drug/indication: Avanafil for erectile dysfunction. Approval decision date: April 29, 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 Amarin ( AMRN) Drug/indication: AMR101 for dyslipidemia. Approval decision date: July 26, 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: firstname.lastname@example.org. Follow TheStreet on Twitter and become a fan on Facebook.