Baxter International Inc. (BAX) announced that the United States Food and Drug Administration or FDA has approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A or AHA, a very rare and potentially life-threatening...
AstraZeneca Plc. (AZN.L, AZN) announced that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has adopted a positive opinion recommending the marketing authorisation of Lynparza (olaparib) as monotherapy for the maintenance treatment of adult patients...
Shares of Hikma Pharmaceuticals Plc (HIK.L, HKMPY.PK) declined around 5percent in the morning trading in London after the company announced Friday that it received a Warning Letter from the U.S. Food and Drug Administration or FDA on Thursday related to the inspection of its manufacturing facility in...
The FDA's Pulmonary Allergy Drugs Advisory Committee has voted 13-2 to recommend approval of Vertex Pharmaceuticals Inc.'s cystic fibrosis drug KALYDECO for expanded use in people with cystic fibrosis ages 6 and older who have the R117H mutation in the cystic fibrosis transmembrane regulatory (CFTR) gene.
NewLink Genetics Corp. has entered into an exclusive worldwide license agreement with Genentech, a member of the Roche Group, for the development of NLG919, NewLink's IDO pathway inhibitor.
Sarepta Therapeutics Inc. (SRPT) announced promising early clinical results from phase I studies of its drug candidates - AVI-6002 and AVI-6003 - for the treatment of Ebola and Marburg virus, respectively.
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California Olive & Vine LLC is voluntarily recalling pumpkin seed pesto, distributed under Williams-Sonoma label, due to potential contamination with deadly bacterium Clostridium botulinum.
North Carolina-based SunBurst Foods, a provider of food services for institutions and distributors, is voluntarily recalling all its products under Sunburst and Fresh Bites brands as well as Private labeled products due to potential contamination with Listeria monocytogenes bacteria.
Gel Spice Co., of Bayonne, New Jersey, is voluntarily recalling 16,443 cases of Fresh Finds Brand Ground Black Pepper due to possible contamination with the harmful Salmonella bacteria.
DateCompany NameTickerDrugEventOutcomeDetails
01/09/2015Impax Laboratories IncIPXLRYTARY (NDA)FDA decision on RYTARY for the treatment of idiopathic Parkinson's disease
12/30/2014POZEN Inc.POZNPA8140/PA32540 (NDA resubmission)FDA decision on PA8140/PA32540 secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
12/30/2014Vertex Pharmaceuticals Inc.VRTXKALYDECO (sNDA)FDA decision on KALYDECO for use in people with cystic fibrosis ages 6 and older who have R117H mutation
12/23/2014Biocryst Pharmaceuticals IncBCRXIntravenous (i.v.) Peramivir (NDA)FDA decision on intravenous Peramivir for influenza
12/21/2014Cubist Pharmaceuticals IncCBSTCeftolozane/Tazobactam (NDA) FDA decision on Ceftolozane/Tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections
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
Tetraphase Pharmaceuticals Inc. (TTPH) has offered to sell 3.95 million shares of common stock to the public at a price of $19.00 each. The offering is expected to close on or about October 22, 2014, subject to customary closing conditions.
Esperion Therapeutics Inc. (ESPR) is offering to sell 4.25 million shares of its common stock to the public at a price of $20.00 each. The offering is expected to close on or about October 21, 2014, subject to customary closing conditions.
All travelers who return from the West African countries plagued by the Ebola virus will be tracked by U.S. health officials. The program, which requires affected parties to have their temperature checked twice daily and report to a local public health department, applies to those who return to the country from Liberia, Guinea or Sierra Leone.
Contract Packaging Resources is recalling nearly 12,000 boxes of the Assured brand naproxen pain relief tablets shipped to Dollar Tree outlets. The recall was issued for 15 count bottles of 220 mg tablets of naproxen sodium, which may actually contain bottles of ibuprofen softgels in 200 mg strength. The ibuprofen tablets represent a threat to those with allergies to the drug.

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