Alexion Pharmaceuticals Inc. (ALXN) announced that the National Institute for Health and Care Excellence or NICE Highly Specialised Technologies Evaluation Committee or EC has recommended that Soliris (eculizumab) be commissioned for all patients in England suffering from atypical hemolytic uremic syndrome...
The FDA has declined to approve Avanir Pharmaceuticals Inc.'s (AVNR) investigational drug-device combination product AVP-825 for the treatment of migraine.
The drug label of Biogen Idec Inc.'s (BIIB) Tecfidera, an oral therapy for multiple sclerosis, has been updated to include information describing the case of a rare and serious brain infection called PML associated with its use, the FDA announced on Tuesday.
Exact Sciences Corp.'s (EXAS) Cologuard will be reimbursed at $502 per test, according to the final payment decision issued by the Centers for Medicare & Medicaid Services.
Shares of Five Prime Therapeutics Inc. (FPRX) rose more than 31 percent on Monday after the company announced that it has established a second collaboration with Bristol-Myers Squibb Co. (BMY) in the area of immuno-oncology.
Bio Blast Pharma Ltd.'s (ORPN) lead product candidate Cabaletta has been granted Orphan Drug Designation by FDA for the treatment of Spinocerebellar Ataxia Type 3 (commonly known as SCA3 and Machado Joseph disease).
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Aurobindo Pharma USA Inc. is voluntarily recalling anti-epileptic medication Gabapentin Capsules, USP 300 mg, distributed through Northstar label, due to complaints of empty capsules.
The FDA has taken enforcement action against Michigan-based Scotty's Inc. for failure to maintain sanitation controls at its food processing facility.
The FDA is warning consumers not to use "Feng Shi Ling," a product promoted and sold as an herbal medication for arthritic pain associated with rheumatoid arthritis and osteoporosis, as it has been found to contain undeclared drug ingredients.
REFA Enterprises LLC is voluntarily recalling "Forever Beautiful Bee Pollen" and "Forever Beautiful Infinity", marketed as dietary supplements for weight loss, as the products have been found to contain undeclared Sibutramine and Phenolphthalein.
DateCompany NameTickerDrugEventOutcomeDetails
02/06/2015Roche Holding AGRHHBYLucentis (sBLA)FDA decision on Lucentis for the treatment of diabetic retinopathy
-Drug Status

01/24/2015Rockwell Medical Technologies IncRMTITriferic (NDA) FDA decision on Triferic for the treatment of iron replacement and maintenance of hemoglobin in hemodialysis patients
01/24/2015Rockwell Medical Technologies IncRMTITriferic (NDA)FDA decision on Triferic for treating iron deficiency in chronic kidney disease patients on hemodialysis
01/09/2015Impax Laboratories IncIPXLRYTARY (NDA)FDA decision on RYTARY for the treatment of idiopathic Parkinson's disease
12/30/2014Vertex Pharmaceuticals Inc.VRTXKALYDECO (sNDA)FDA decision on KALYDECO for use in people with cystic fibrosis ages 6 and older who have R117H mutation
Submission DateCompany NameTickerDeviceCategoryOutcomeDetails
07/25/2014Guided Therapeutics, Inc.GTHP.OBLuViva Advanced Cervical Scan.PMA (Amended)
04/07/2014Myriad Genetics Inc.MYGNBRACAnalysis as a companion testPMA (First module)
04/01/2014STEREOTAXIS INCSTXSVdrive Robotic Navigation System with V-Loop Variable Loop Catheter Manipulator510(k)
02/18/2013EXACT Sciences Corp.EXASSecond module for stool DNA colorectal cancer screening test PMA
12/07/2012EXACT Sciences Corp.EXASFirst module for stool DNA colorectal cancer screening test PMA
Medgenics Inc. (MDGN) has offered to sell 5.12 million shares of its common stock to the public at a price of $4.10 each. The underwriters have a 30-day option to purchase up to an additional 768,750 shares of the company's common stock. The offering is scheduled to close on or about December 1, 2014.
Rockwell Medical Inc. (RMTI) has offered to sell 6.5 million shares of its common stock to the public at a price of $9.00 each. The company has also granted underwriters a 30-day option to purchase up to an additional 975,000 shares.
Those who smoke hookahs and other water pipes may inhale toxic levels of benzene with every puff, according to a new study from researchers at the Center for Behavioral Epidemiology and Community Health at San Diego State University. For the study the researchers analyzed the urine of 105 hookah smokers and 103 non-smokers who had been exposed to hookah smoke.
People in unhappy marriages may be more likely to suffer from poor cardiovascular health, according to a new study from researchers at Michigan State University. For the study the researchers reviewed health data from 1,200 married couples who were surveyed as part of the National Social Life, Health and Aging Project.

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