Boston Scientific Corp. (BSX) Tuesday said its surgical leads - CoverEdge 32 and CoverEdge X 32 - have received U.S. Food and Drug Administration approval as well as the CE Mark from European Union to provide software-guided stimulation to the spinal cord for relieving pain. The company said CoverEdge...
Eli Lilly and Co. (LLY) Tuesday said the U.S. Food and Drug Administration or FDA has accepted its filing of New Drug Application or NDA for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, which is an investigational compound being studied for the treatment of adults...
West Pharmaceutical Services, Inc. (WST), Tuesday said its Vial2Bag DC device, which transfers drugs from their vials to IV bags, has received the 510(k) clearance from the U.S. Food and Drug Administration, as well as the CE Mark for the European Union. "Our new Vial2Bag DC device simplifies the...
NewLink Genetics Corp. has entered into an exclusive worldwide license agreement with Genentech, a member of the Roche Group, for the development of NLG919, NewLink's IDO pathway inhibitor.
Sarepta Therapeutics Inc. (SRPT) announced promising early clinical results from phase I studies of its drug candidates - AVI-6002 and AVI-6003 - for the treatment of Ebola and Marburg virus, respectively.
TriVascular Technologies Inc. announced Wednesday that the FDA has approved CustomSeal Technology for its Ovation Prime System, a minimally invasive device treatment for abdominal aortic aneurysm.
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California Olive & Vine LLC is voluntarily recalling pumpkin seed pesto, distributed under Williams-Sonoma label, due to potential contamination with deadly bacterium Clostridium botulinum.
North Carolina-based SunBurst Foods, a provider of food services for institutions and distributors, is voluntarily recalling all its products under Sunburst and Fresh Bites brands as well as Private labeled products due to potential contamination with Listeria monocytogenes bacteria.
Gel Spice Co., of Bayonne, New Jersey, is voluntarily recalling 16,443 cases of Fresh Finds Brand Ground Black Pepper due to possible contamination with the harmful Salmonella bacteria.
DateCompany NameTickerDrugEventOutcomeDetails
01/09/2015Impax Laboratories IncIPXLRYTARY (NDA)FDA decision on RYTARY for the treatment of idiopathic Parkinson's disease
12/30/2014POZEN Inc.POZNPA8140/PA32540 (NDA resubmission)FDA decision on PA8140/PA32540 secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
12/23/2014Biocryst Pharmaceuticals IncBCRXIntravenous (i.v.) Peramivir (NDA)FDA decision on intravenous Peramivir for influenza
12/21/2014Cubist Pharmaceuticals IncCBSTCeftolozane/Tazobactam (NDA) FDA decision on Ceftolozane/Tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections
12/05/2014Incyte CorporationINCYRuxolitinib (sNDA)FDA decision on Ruxolitinib as a potential treatment in the addnl. indication of polycythemia vera patients who have had an inadequate response to or are intolerant of hydroxyurea
-Approved in Other Countries

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
Tetraphase Pharmaceuticals Inc. (TTPH) has offered to sell 3.95 million shares of common stock to the public at a price of $19.00 each. The offering is expected to close on or about October 22, 2014, subject to customary closing conditions.
Esperion Therapeutics Inc. (ESPR) is offering to sell 4.25 million shares of its common stock to the public at a price of $20.00 each. The offering is expected to close on or about October 21, 2014, subject to customary closing conditions.
U.S. health officials are tightening recommendations for health care workers handling ebola cases. The guidelines, which have not been released in full, are expected to include the requirement for full skin coverage suits to be worn by health workers. In addition, the guidelines will include provisions for stricter rules for removing equipment and disinfecting hands.
Sugar speeds up the aging process as much as smoking, according to research conducted at the University of California at San Francisco. The study, published in the American Journal of Public Health, surveyed data on over 5,300 healthy Americans from a National Health and Nutrition Examination Survey (NHANES).
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