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 The leading web portal for pharmacy resources, news, education and careers April 24, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - April 24, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 48     Next >>     Go To Page:

4/24/14 - Aurora Spine Receives FDA 510(k) Clearance for Additional Sizes of Sterile-Packed ZIP ULTRA(TM) and the New ZIP(TM) MIS System
Aurora Spine Corporation announced today that it has received U.S. Food and Drug Administration 510 clearance for additional sizes of the company's sterile-packed ZIP ULTRA? Minimally Invasive Interspinous Fusion System and clearance for the company's new sterile-packed ZIP? MIS system. This is another step in Aurora Spine's effort to provide t
4/24/14 - Baxter Announces FDA Approval of ADVATE (Antihemophilic Factor [Recombinant]) with BAXJECT III Reconstitution System
DEERFIELD, Ill.- Baxter International Inc. today announced that the U.S. Food and Drug Administration has approved a new reconstitution system for ADVATE. "ADVATE has the widest range of dosage formulations, allowing for more precise customized dosing, and with the ADVATE with BAXJECT III reconstitution system, patients can prepare their treatment
4/24/14 - FDA Approves Cochlear Limited Aqua+ Accessory [Travel & Leisure Close - Up]
Cochlear Limited, a provider of implantable hearing solutions, announced that the US Food and Drug Administration has approved the Aqua+ accessory, a waterproof behind-the-ear solution for cochlear implant recipients. The Aqua+ is a form-fitting accessory that allows Cochlear Nucleus 5 and Nucleus 6 Implant recipients2 to swim underwater for up to
4/24/14 - FDA approves Sylvant for rare Castleman's disease
Release date- 23042014- The U.S. Food and Drug Administration today approved Sylvant to treat patients with multicentric Castleman's disease, a rare disorder similar to lymphoma. 'Sylvant is the first FDA- approved drug to treat patients with MCD,' said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Ce
4/24/14 - FINRA Clears Rule 15c2-11 Submission and Issues Symbol PCFTF
VANCOUVER, BC, CANADA/ ACCESSWIRE/ April 24, 2014- Pacific Therapeutics Ltd. is a clinical stage specialty pharmaceutical company focused on the repurposing and reformulation of existing FDA approved drugs for large markets. The Company is pleased to announce that the Financial Industry Regulatory Authority has approved the Company's rule 15 c2-11.
4/24/14 - Quarterly Results, FDA Approvals, Intellectual Property Appeals, New Drug Applications, and Initiated Clinical Trials - Analyst Notes on Johnson & Johnson, Merck, Teva, Bristol-Myers Squibb and AbbVie
Today, Analysts Review released its analysts' notes regarding Johnson& Johnson, Merck& Co., Inc., Teva Pharmaceutical Industries Ltd, Bristol-Myers Squibb Company and AbbVie Inc.. Johnson& Johnson Analyst Notes On April 15, 2014, Johnson& Johnson announced Q1 2014 financial results. Net earnings were $4.7 billion, or $1.64 per diluted share, compar
4/24/14 - Solvay's Amodel PPA and Ixef PARA Receive Regulatory Approval for Food-Contact Use; Latest Products Expand Solvay's Portfolio of Food-Contact Polymers for Household Appliances
Release date- 23042014- SHANGHAI, China- Several grades of Solvay Specialty Polymers' Amodel polyphthalamide and Ixef polyarylamide polymers have received clearance by U.S. and European regulatory authorities for use in food-contact applications. The four compounds, which meet U.S. Food& Drug Administration regulations and EU Commission Regulation
4/23/14 - Baxter Announces FDA Approval of ADVATE (Antihemophilic Factor [Recombinant]) with BAXJECT III Reconstitution System
Baxter International Inc. today announced that the U.S. Food and Drug Administration has approved a new reconstitution system for ADVATE. ''ADVATE has the widest range of dosage formulations, allowing for more precise customized dosing, and with the ADVATE with BAXJECT III reconstitution system, patients can prepare their treatment with fewer steps
4/23/14 - Calgary Scientific Receives FDA Clearance for Mobile Diagnosis on all Modalities
By a News Reporter-Staff News Editor at Biotech Week Calgary Scientific Inc., a company known for creating transformative technology for the medical industry and beyond, announced their latest Class II clearance from the United States Food and Drug Administration. Calgary Scientific worked closely with a number of Radiologists at a world renowned
4/23/14 - Fate Therapeutics Announces FDA Clearance of IND Amendment for Clinical Development of PROHEMA
Fate Therapeutics, Inc., a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, announced today that the U.S. Food and Drug Administration has cleared its Investigational New Drug Application amendment to evaluate PROHEMA in pediatric patients undergoing hematopoietic stem cel
4/23/14 - Fate Therapeutics Announces FDA Clearance of IND Amendment for Clinical Development of PROHEMA(R) in Pediatric Patients
Fate Therapeutics, Inc., a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, announced today that the U.S. Food and Drug Administration has cleared its Investigational New Drug Application amendment to evaluate PROHEMA in pediatric patients undergoing hematopoietic stem c
4/23/14 - FDA Announces Availability of Draft Guidance Entitled 'Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for...
WASHINGTON, April 23 The U.S. Department of Health and Human Services published the following notice in the Federal Register from the Food and Drug Administration:. Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Disease or Conditions; Draft Guidance for Ind
4/23/14 - FDA Clears Siemens SOMATOM Force CT System
Siemens Healthcare has announced that the U.S. Food and Drug Administration has cleared the SOMATOM Force computed tomography system the next generation in dual source CT. With two sets of Siemens most innovative X-ray tubes and detectors, the SOMATOM Force extends advanced imaging to all patients, including some of the most challenging: y
4/23/14 - GE Healthcare Receives FDA Clearance For Q.Clear Technology
By a News Reporter-Staff News Editor at Biotech Week GE Healthcare, a unit of General Electric Company, announced that it received U.S. FDA 510 clearance of its Q.Clear ^ technology- technology that can provide up to two times improvement in both quantitative accuracy and image quality in PET/CT imaging. GE Healthcare's new Q.Clear technology sho
4/23/14 - Global Vitamin D Testing Market 2014-2018
Research and Markets has announced the addition of the "Global Vitamin D Testing Market 2014-2018" report to their offering. For instance, Qualigen Inc. received the FDA approval for FastPack Vitamin D Immunoassay for use on its proprietary FastPack System for the rapid determination of vitamin D status, and Gold Standard Diagnostics Corp. obtained
4/23/14 - Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5 percent and 10 percent Readily Available
By a News Reporter-Staff News Editor at Biotech Week- Paragon BioTeck, Inc., a privately held biopharmaceutical company specializing in the development of ophthalmic pharmaceuticals and therapies, received FDA approval of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, to dilate the pupil on March 21, 2013. There is no longer a
4/23/14 - SYLVANT? (siltuximab) Receives FDA Approval to Treat Multicentric Castleman's Disease (MCD)
Janssen Biotech, Inc. today announced the U.S. Food and Drug Administration has approved SYLVANT? for the treatment of patients with multicentric Castleman's disease who are human immunodeficiency virus negative and human herpesvirus-8 negative. "There has been a serious need for treatment options for patients with MCD," said Frits van Rhee, M.D
4/23/14 - World's First and Only Upgradeable Spinal Cord Stimulation System Receives FDA Approval
By a News Reporter-Staff News Editor at Journal of Engineering "In the first 40 years of SCS we've seen advances in hardware but limited progress in software and programming. This new device evolves with promising therapies, "said Dr. Timothy Deer, an interventional pain physician, president and CEO of the Center for Pain Relief in Charleston, W.
4/22/14 - Ahead of the Bell: Shares of drugmaker Lilly slip
Eli Lilly and Co. received a key regulatory approval for a new cancer treatment Monday evening, but the drugmaker's shares slipped in premarket trading Tuesday after Lilly also announced a $5.4 billion acquisition. The Food and Drug Administration said on Monday it had approved Cyramza to treat patients with a form of advanced stomach cancer or a c
4/22/14 - BRIEF: FDA approves new Eli Lilly and Co. drug to treat stomach cancer [The Indianapolis Star :: ]
April 22 Eli Lilly and Co. will put a new cancer drug on the market after receiving federal marketing approval Monday. The drug was developed by ImClone Systems, which Lilly acquired in 2008. In addition to the stomach cancer use, the company hopes to receive FDA approval for ramucirumab against lung, liver and colorectal cancers. Call Star repor
4/22/14 - Cochlear Receives FDA Approval of the Aqua+ Accessory - the Cochlear Nucleus System is Now the World's Most Waterproof Cochlear Implant System [Global Data Point]
"With the approval of the Aqua+ accessory, recipients can have the confidence that they have the world's most waterproof cochlear implant system on the market, while benefitting from the sleek, form-fitting, behind-the-ear design that truly makes it one-of-a-kind," said Chris Smith, President of Cochlear Americas. The Aqua+ Kit, which consists of a
4/22/14 - FDA approves Cyramza for stomach cancer
Release date- 21042014- The U.S. Food and Drug Administration today approved Cyramza to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach. According to the National Cancer Institute, an estimated 22,220 Americans will be diagnosed wit
4/22/14 - FDA Clears Erchonia's New Allay Laser for Chronic Heel Pain from Plantar Fasciitis
Erchonia today announces the U.S. Food and Drug Administration has granted the company 510 clearance to market Allay, its new low level laser for the relief of chronic heel pain from plantar fasciitis. Erchonia received FDA clearance based on a double-blind, randomized, multi-site and placebo-controlled clinical trial. Michael Coughlin, MD, the cli
4/22/14 - FDA Grants Approval to Merck's Ragwitek [Health & Beauty Close - Up]
Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration has approved Ragwitek Tablet for Sublingual Use. David Skoner, director, Division of Allergy and Immunology, Allegheny Health Network, and a clinical investigator in Merck's sublingual allergen immunotherapy tablet program. "While there a
4/22/14 - FDA plan would speed up medical device approvals
WASHINGTON The Food and Drug Administration unveiled a proposal Tuesday designed to speed up development and approval of medical devices that treat life-threatening diseases and debilitating conditions. Under the Expedited Access Program, companies developing devices for critical and unmet medical needs would get earlier access to FDA staff to..
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