Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) said Thursday that the U.S. Food and Drug Administration has approved a Supplemental New Drug Application for Eliquis for the treatment of deep vein thrombosis and pulmonary embolism, and for the reduction in the risk of recurrent DVT and PE following...
Dutch consumer electronics giant Koninklijke Philips Electronics NV (PHGFF.PK, PHG) has received 510(k) clearance from the U.S. Food and Drug Administration to market its precision planning application for Transcatheter Aortic-Valve Implantation or TAVI treatments. Through 3D imaging, the Philips TAVI...
GlaxoSmithKline plc (GSK, GSK.L) said Wednesday that the FDA has approved Arnuity Ellipta, a once-daily inhaled corticosteroid medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm. The...
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Shares of CorMedix Inc. (CRMD) were up more than 8 percent in extended trading on Thursday, following a double dose of good news.
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Epizyme Inc. on Tuesday said that in an ongoing phase I dose escalation study of EPZ-6438 in patients with advanced solid tumors and B-cell lymphomas, the maximum tolerated dose has not been reached, meaning that the compound is well tolerated. The company also noted that there were no dose-limiting toxicities or adverse events-related treatment discontinuations.
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In the civil suit filed by PharmAthene Inc. (PIP) against SIGA Technologies Inc. (SIGA), the Delaware Court of Chancery has ruled that PharmAthene is entitled to lump sum expectation damages for its lost profits related to smallpox antiviral Tecovirimat (previously known as ST-246).
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The TJX Companies Inc. is recalling "ecoato" brand Sweet Paprika Powder from store shelves due to potential contamination with Salmonella bacteria. Investigation is being carried out to identify the source of the contamination.
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The FDA is warning consumers to avoid powdered pure caffeine sold over the internet as it is potentially dangerous and can result in death. Caffeine is one of the most commonly used stimulants in the U.S.
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White & Blue Lion Inc. is recalling all lots of tattoo inks, tattoo needles and tattoo kits due to pathogenic bacterial contamination. The recall was initiated after FDA Laboratory testing found microbial bacterial contamination in both the inks and needles.
Eye health products company Bausch & Lomb has recalled about 850,000 tubes of Muro 128, an eye-care ointment, the Wall Street Journal said Thursday. Bausch & Lomb, owned by Canada-based Valeant Pharmaceuticals International Inc (VRX, VRX.TO), effected the recall as some of the ointment tubes contained...
DateCompany NameTickerDrugEventOutcomeDetails
10/28/2014Merck & Co Inc.MRKMK-3475 (BLA)FDA decision on MK-3475 for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab
10/24/2014NPS Pharmaceuticals IncNPSPNatpara (BLA)FDA decision on Natpara for the treatment of hypoparathyroidism
10/24/2014Roche Holding AGRHHBYAvastin (sBLA)FDA decision on Avastin plus chemotherapy for the treatment of women with persistent, recurrent or metastaticcervical cancer
10/23/2014Regeneron PharmaceuticalsREGNEYLEA (sBLA)FDA decision on EYLEA for the expanded indication of of Macular Edema following Branch Retinal Vein Occlusion
-Approved in Other Countries

10/20/2014Auxilium Pharmaceuticals Inc.AUXLXIAFLEX (sBLA) FDA decision on XIAFLEX for the treatment of two Dupuytren's contracture (DC) cords concurrently
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
NeoGenomics Inc. (NEO), a provider of cancer-focused genetic testing services, announced that it has priced an underwritten public offering of 7.0 million shares of common stock at a price to the public of $4.60 per share. It will result in gross proceeds to the company of $32.2 million. The transaction...
Cellectar Biosciences Inc. (CLRB) has priced an underwritten public offering of 3.33 million shares of its common stock at $3.75 each and warrants at $0.01 each.
Children and unborn babies are at a higher risk of harm from microwave radiation [MWR] emitted by cellular phones than adults, according to research conducted at the Environmental Health Trust. The study, published in the Journal of Microscopy and Ultrastructure, surveyed data on cell phone exposure studies from 2009-2014.
Colds and other minor infections may temporarily increase the risk of stroke in children, according to research conducted at the UCSF Benioff Children's Hospital San Francisco. The study, published in the journal Neurology, surveyed data on 2.5 million kids, 102 of whom had an ischemic stroke without a major infection such as meningitis or sepsis.

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