Teleflex Inc. (TFX), a provider of medical devices for critical care and surgery, Tuesday said its unit Hotspur Technologies, Inc. received the U S Food and Drug Administration or FDA's 510(k) clearance to market its Arrow GPSCath Balloon Dilatation Catheters, designed for use with .014 inch guide wires...
European Commission has approved Gazyvaro, a glycoengineered monoclonal antibody, for treating chronic lymphocytic leukemia, Roche (RHHBY) said in a statement Tuesday. Roche expects to start introducing Gazyvaro in a number of European countries this year. "Gazyvaro is a new option that helps patients...
Aqua Pharmaceuticals, an Almirall company, announced the U.S. Food and Drug Administration or FDA approval of the NDA for Acticlate (doxycycline hyclate USP) Tablets, 150 mg and 75 mg, thereby continuing Aqua's leadership in medical dermatology and oral antibiotics for acne. Acticlate is a tetracycline-class...
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Alexza Pharmaceuticals Inc. (ALXA) is all set to initiate a phase 2a study of AZ-002 for the management of patients with acute repetitive seizures in the second half of 2014.
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Shares of EDAP TMS SA (EDAP) plunged more than 40 percent in extended trading on Wednesday after an FDA advisory committee snubbed the company's Ablatherm-HIFU device as a treatment for low-risk, localized prostate cancer.
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ZELTIQ Aesthetics Inc. has upped its full-year 2014 revenue outlook, following better-than-expected Q2 results, thanks to the growing momentum and awareness for CoolSculpting, the company's non-surgical contouring treatment for fat reduction.
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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
TherapeuticsMD Inc. (TXMD) has priced an underwritten public offering of roughly 8.6 million shares at $4.67 each. In addition, the underwriters have been offered an option for a period of 30 days to purchase, at the public offering price less the underwriting discount, up to approximately 1.3 million additional shares.
La Jolla Pharmaceutical Co (LJPC) Wednesday priced an underwritten offering of 4.8 million shares of its common stock at $10.50 per share. La Jolla has granted the underwriters a 30-day option to purchase up to an additional 720,000 shares of common stock. The offering is expected to close on...
A simple blood test could predict the risk of suicide, according to a new study from researchers at Johns Hopkins Medical Center. For the study the researchers focused specifically on one particular gene variant known as SKA2. While examining the brains of deceased mental illness patients, the researchers discovered that those who had died of suicide have low levels of the SKA2 gene variant.
The use of statins may enable faster recovery times after cardiac surgery, according to a study from researchers at Our Lady's Children's Hospital in Dublin, Ireland. For the study the researchers reviewed data from 20 cohort studies involving statin use and heart surgery. They found that on average those using statins following heart surgery had a reduced wound healing time.

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