Baxter International Inc. (BAX) said the U.S. Food and Drug Administration or FDA has approved a new reconstitution system for Antihemophilic Factor [Recombinant] or ADVATE. ADVATE and the diluent come pre-packaged in the new BAXJECT III reconstitution system. "ADVATE has the widest range of dosage...
OncoGenex Pharmaceuticals, Inc. (OGXI) Wednesday said the U.S. Food and Drug Administration has granted Fast Track designation to the investigation of Custirsen in combination with cabazitaxel/prednisone for the treatment of men with metastatic castrate-resistant prostate cancer, following treatment...
Quidel Corp. (QDEL) said Tuesday that it has received clearance, via the De Novo Request process, from the United States Food and Drug Administration to market its Lyra Direct Strep Assay, a multiplex real-time PCR assay. The new molecular test detects and differentiates between pyogenic Group A...
The Food and Drug Administration advisory panel has unanimously voted against recommending QRxPharma Ltd.'s (QRXPY.OB) Moxduo, an immediate release Dual Opioid for the treatment of moderate to severe acute pain. The FDA's final decision is slated for May 25, 2014.
The FDA has approved Eli Lilly and Co.'s (LLY) Cyramza to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma. The National Cancer Institute estimates that 22,220 Americans will be diagnosed with stomach cancer and 10,990 will die from the disease, this year. Cyramza enjoys orphan product designation for this indication.
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.
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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
07/22/2014Eagle Pharmaceuticals IncEGRXRyanodex (NDA)FDA decision on Ryanodex treatment of malignant hyperthermia
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
06/25/2014AstraZeneca PLCAZN.L, AZNOlaparib capsules (NDA)FDA panel to review Olaparib as monotherapy for relapsed ovarian cancer
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

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
A majority of Americans support mandatory birth control coverage as part of Obamacare, according to a new study from researchers at the University of Michigan. In the study the researchers found that 69 percent of all the respondents were in favor of such coverage. "In this study, women, blacks, and Hispanics were more likely to support coverage of birth control medications than were men . . ."
A new study has revealed that pregnant women who are obese during their pregnancy have an increased risk of having a stillborn baby. The new study, based at Drexel University, examined data from 2.8 million single-child deliveries between 2003 and 2011, taking into account women who were of normal weight, overweight and obese.
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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