InnoPharma Inc. announced that the U.S. Food and Drug Administration has approved its Abbreviated New Drug Application or ANDA for decitabine for injection, a generic version of Eisai Inc.'s Dacogen. InnoPharma developed the generic formulation of decitabine for injection and entered into an agreement...
Amgen (AMGN) announced the submission of a Biologics License Application (BLA) to the U.S. FDA for evolocumab seeking approval for the treatment of high cholesterol. The company said its BLA for evolocumab contains data from approximately 6,800 patients, including more than 4,500 patients with high cholesterol...
ACADIA Pharmaceuticals Inc. (ACAD) announced the U.S. FDA has provisionally accepted the trade name, NUPLAZID, for pimavanserin. NUPLAZID is a selective serotonin inverse agonist. NUPLAZID has successfully completed a pivotal Phase III trial in Parkinson's disease psychosis, which the FDA has agreed...
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Shares of Kite Pharma Inc. surged over 28 percent to $28.70 in after-hours Monday, following publication of positive findings about an anti-CD19 chimeric antigen receptor (CAR) T cell therapy in an ongoing phase 1-2a clinical trial.
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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.
DateCompany NameTickerDrugEventOutcomeDetails
11/26/2014Avanir PharmaceuticalsAVNRAVP-825 (NDA)FDA decision on AVP-825 for the acute treatment of migraine.
-Drug Status

-News
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

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
BiliCam, a new smartphone app, allows users to detect jaundice in newborn babies by simply snapping a picture. The disorder, often difficult to detect in newborns, is caused by insufficient elimination of the chemical bilirubin in the baby's system. Babies who do not sufficiently expel the chemical can often appear yellow; however, the discoloration isn't always apparent to the naked eye.
September is National Suicide Prevention Awareness Month during which we are urged to remember that "silence hurts us all." The campaign encourages everyone to fight the stigma of mental illness by reaching out to those who may need help and by sharing one's own experiences with mental health disorders. Many localities are scheduling walks, fundraisers or other activities to raise awareness.
Falls are common in people with multiple sclerosis, and roughly half of these falls are said to result in an injury requiring medical attention. New research now suggests a promising tool to help people with multiple sclerosis reduce their risk of accidental falls. Guess what!

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