The U.S. FDA announced it has approved Ragwitek, an allergen extract administered sublingually to treat short ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults 18 years through 65 years of age. Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia)...
GlaxoSmithKline plc (GSK, GSK.L) said Tuesday that the U.S. Food and Drug Administration has approved Tanzeum subcutaneous injection as a once-weekly treatment for type 2 diabetes. Tanzeum has been approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes...
Merck & Co. Inc. (MRK) said Monday that the U.S. Food and Drug Administration has approved Grastek Tablet for Sublingual Use. Grastek is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin...
Zogenix Inc. (ZGNX) rose more than 10 percent in extended trading on Tuesday to $2.59 following the Court's order preventing the implementation of the Governor's order that blocked access to Zohydro ER on Constitutional grounds.
Intercept Pharmaceuticals Inc.'s (ICPT) phase III trial of its lead product candidate, OCA, for the treatment of primary biliary cirrhosis, dubbed POISE, has demonstrated notable improvements on key endpoints - achieving a highly statistically significant reduction in alkaline phosphatase - as early as two weeks, with a peak effect achieved by six months.
AngioDynamics Inc. (ANGO) has turned a profit in its fiscal 2014 third quarter as sales grew 8 percent, reflecting continued market acceptance of its innovative products.
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SINCO INC is voluntarily recalling Archer Farms Chocolate Hazelnut Swirl Gelato due to potential presence of traces of peanut protein, which is not declared on the label.
Consumers should immediately stop using Zi Xiu Tang Bee Pollen capsules, marketed as a product for weight loss and body reshaping, as it contains undeclared drug ingredients with health risks, warns the FDA.
Natural Organics Inc. is voluntarily recalling one lot of THURSDAY PLANTATION TEA TREE MOUTHWASH due to bacterial contamination.
Consumers should not use New You, a product promoted for weight loss, as it contains ingredients like sibutramine and phenolphthalein, warns the FDA.
DateCompany NameTickerDrugEventOutcomeDetails
07/16/2014Salix Pharmaceuticals LtdSLXPRuconest (BLA)FDA decison on Ruconest for the treatment of acute angioedema attacks in patients with hereditary angioedema
07/15/2014MannKind Corp.MNKDAFREZZA Inhalation Powder (NDA) FDA decision on AFREZZA Inhalation Powder to improve glycemic control in adult patients suffering from type I or type II diabetes
06/20/2014Cubist Pharmaceuticals IncCBSTTedizolid phosphate (NDA) FDA decision on Tedizolid phosphate for the treatment of acute bacterial skin and skin structure infections
-Drug Status

06/16/2014Navidea Biopharmaceuticals, Inc.NEOP, NAVBLymphoseek Injection ?(sNDA)FDA decision on Lymphoseek Injection for sentinel lymph node detection in patients with head and neck cancer
06/10/2014Orexigen Therapeutics Inc.OREXContrave (NDA resubmission)FDA decision on Contrave for weight loss and maintenance of weight loss.
Submission DateCompany NameTickerDeviceCategoryOutcomeDetails
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
11/27/2012GIVEN IMAGING LTDGIVNPillCam COLON 2 for visualization of lower gastrointestinal tract Regulatory Clearance
Free drug samples may be costly in the long run, according to a new study from researchers at Stanford. For the study the researchers worked with a team of dermatologists to see how free samples impact their prescribing practices. In 2010 they found that 18 percent of all prescriptions from the dermatologist group included a free sample of some drug.
The effects of childhood bullying may persist into adult years, according to research conducted at King's College London. The study, published by Beat Bullying, surveyed data collected on 7,771 kids whose parents detailed exposure to bullying. Bullying happened to roughly 28% of the children surveyed and had a negative physical and cognitive effect on that percentage of kids.
A wide range of consumer products contain certain nanoparticles that can harm our DNA, according to a new study from Massachusetts Institute of Technology and the Harvard School of Publich Heath. Manufacturers use nanoparticles to improve texture, kill microbes, or enhance shelf life, etc., in consumer...
Covering our nose and mouth with a tissue when coughing or sneezing is a "respiratory etiquette" that is practiced to prevent the spread of germs. Minute liquid droplets emerge when we cough and sneeze, and these droplets can be seen and felt. But what we don't see are the invisible gas clouds associated with those coughs and sneezes, which enable the droplets to stay airborne and travel distances

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