Astrazeneca (AZN,AZN.L) said the European Commission or EC has granted Marketing Authorisation for Lynparza or olaparib capsules, 400mg twice daily, as the first therapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated high grade serous epithelial ovarian,...
The U.S. Food and Drug Administration approved Xtoro or finafloxacin otic suspension, a new drug used to treat acute otitis externa, commonly known as swimmer's ear. Xtoro is manufactured Alcon Laboratories, Inc., based in Fort Worth, Texas. Acute otitis externa is an infection in the outer ear and...
The U.S. Food and Drug Administration has approved Cerus Corp.'s (CERS) Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections or TTI. The Intercept Blood...
Tetraphase Pharmaceuticals Inc.'s first of the two pivotal trials, dubbed IGNITE 1, evaluating its drug candidate Eravacycline for the treatment of complicated intra-abdominal infection has achieved the primary endpoint of statistical non-inferiority.
Shares of Auspex Pharmaceuticals Inc. (ASPX) were up more than 63 percent in extended trading on Tuesday after the company reported positive topline results from a pivotal phase III trial of its drug candidate SD-809 for chorea associated with Huntington's disease.
Auspex Pharmaceuticals Inc. (ASPX) surged more than 63 percent in extended trading on Tuesday after reporting positive topline results from its phase III registration trial evaluating SD-809 for the treatment of chorea associated with Huntington's disease.
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Del Monte Fresh Produce N.A. Inc. is voluntarily recalling fresh cut fruit packages containing Gala red apples in a few States in North East U.S. because the apples have the potential to be contaminated with the harmful Listeria monocytogenes bacteria.
Global Garlic Inc. is recalling De Mi Pais products - Cuajada Fresca (Fresh Curd) and Cuajada Olanchana (Fresh Curd) - due to possible contamination with the bacterium Listeria monocytogenes.
Overhill Farms Inc. of Vernon, California is voluntarily recalling Open Nature Chile Cheese Enchiladas, a frozen prepared dinner, due to possible contamination with the harmful Salmonella bacteria.
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.
DateCompany NameTickerDrugEventOutcomeDetails
03/05/2015Pacira Pharmaceuticals, Inc.PCRXEXPAREL (sNDA)FDA decision on EXPAREL for use in femoral nerve block for total knee arthroplasty
-Approved in Other Countries

02/28/2015Actavis Plc.ACTLevosert (NDA)FDA decision on Levosert, a hormonal intrauterine contraceptive for use by women to prevent pregnancy.
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
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
Trevena Inc. (TRVN) has offered to sell 11.25 million shares of its common stock to the public at a price of $4 each. The underwriters have a 30-day option to purchase up to 1.68 million additional shares.
The use of a low glycemic index diet may not be linked with improved metabolism, according to a new study from researchers at the Harvard School of Public Health. For the study the researchers enrolled 163 overweight adults into one of four different groups for a customized diet. Those who followed a low-glycemic index, low-carbohydrate diet didn't show any specific metabolic improvements.
Chain restaurants will be required to post the calories of their alcoholic drinks by November 2015. The new rules, set up by the Food and Drug Administration, require chain restaurants with 20 or more outlets to list the number of calories each alcoholic drink, including craft beer, has on its menu.

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