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 The leading web portal for pharmacy resources, news, education and careers April 23, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - April 23, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 47     Next >>     Go To Page:

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4/23/14 - FDA Announces Availability of Draft Guidance Entitled 'Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for...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 - 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 - 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..
4/22/14 - Quidel Receives FDA Clearance for Its Lyra(TM) Molecular PCR Assay for the Detection of Infections From Pyogenic Streptococcus Group A and C or G
Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today 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.
4/22/14 - World's First and Only Upgradeable Spinal Cord Stimulation System Receives FDA Approval
By a News Reporter-Staff News Editor at Journal of Technology "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.
4/21/14 - Boston Scientific Gets FDA Approval of New Defibrillators and Heart Failure Devices [Health & Beauty Close - Up]
Boston Scientific Corp. said that it has received FDA approval for its latest generation of defibrillators and heart failure devices designed to advance patient care. These newly approved devices continue the Boston Scientific history of projected longevity and a six-year CRT-D warranty. Extending the Boston Scientific portfolio of defibrillators,.
4/21/14 - Cochlear Receives FDA Approval of the Aqua+ Accessory - the Cochlear? Nucleus System is Now the World's Most Waterproof Cochlear Implant System(1)
Cochlear Limited, the global leader in implantable hearing solutions, announced that the US Food and Drug Administration has approved the Aqua+ accessory, the only waterproof behind-the-ear solution for cochlear implant recipients on the market today. "With the approval of the Aqua+ accessory, recipients can have the confidence that they have the
4/21/14 - FDA Approves Cyramza For Stomach Cancer
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release: 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.
4/21/14 - FDA Approves Lipiodol Ethiodized Oil Injection for Imaging of Tumors in Adults with Known Hepatocellular Carcinoma HCC
By a News Reporter-Staff News Editor at Pharma Business Week Guerbet, a pioneer in the field of contrast agents for medical imaging announced that Lipiodol was approved by the US Food and Drug Administration pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act indicated for selective hepatic intra-arterial use for imaging tumors
4/21/14 - NEC Display Solutions Receives FDA 510k Clearance on MD302C4 Diagnostic Review Monitor
By a News Reporter-Staff News Editor at Pharma Business Week NEC Display Solutions of America, a leading provider of commercial LCD display and projector solutions, announced the Food and Drug Administration 510 market clearance of the 30- inch MultiSync MD302C4 LCD, a widescreen display for diagnostic review applications in healthcare organiz
4/21/14 - Newly-Approved Brain Stimulator Offers Hope for Individuals With Uncontrolled Epilepsy
Rush University Medical Center issued the following news release:. A recently FDA- approved device has been shown to reduce seizures in patients with medication-resistant epilepsy by as much as 50 percent. Marvin Rossi, co-principal investigator of the NeuroPace Pivotal Clinical Trial and assistant professor of neurology at the Rush Epilepsy Center
4/21/14 - Par Pharmaceutical Begins Shipment of Potassium Chloride Extended-Release Capsules
By a News Reporter-Staff News Editor at Pharma Business Week Par Pharmaceutical Companies, Inc. announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for potassium chloride extended-release capsules, USP, in 600 mg and 750 mg strengths. According to IMS Health data, annua
Articles(s): 1 - 25 of 47     Next >>     Go To Page:


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