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 The leading web portal for pharmacy resources, news, education and careers August 1, 2015
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - August 1, 2015

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 59     Next >>     Go To Page:

7/31/15 - Corvida gets FDA approval to market first product [The Gazette, Cedar Rapids, Iowa]
July 31 Corvida Medical, a Coralville medical device developer, has received U.S. Food and Drug Administration 510 clearance to market its first product, Halo. The device received an ONB product code classification from the FDA, demonstrating there is no escape of hazardous drug or vapor concentration, no transfer of environmental contaminants, a
7/31/15 - Cytori Licensee Kerastem Secures Conditional Approval from FDA for Alopecia Trial [Health & Beauty Close - Up]
Cytori Therapeutics reported that Kerastem Technologies received U.S. Food and Drug Administration conditional Investigational Device Exemption approval to conduct a clinical trial studying the safety and feasibility of its technology for the treatment of female and early male pattern baldness. The data will be presented in September at the 2015...
7/31/15 - FDA Approves Bayer's Finacea (azelaic acid) Foam, 15% for the Topical Treatment of the Inflammatory Papules and Pustules of Mild to Moderate Rosacea
Bayer HealthCare today announced that the U.S. Food and Drug Administration has approved Finacea Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. "The FDA approval of Finacea Foam is the result of several years of research and development," said James Robins, VP& General Manager, Bay
7/31/15 - Finacea(R) (azelaic acid) Foam 15%, Approved by U.S. FDA for Topical Treatment of the Inflammatory Papules and Pustules of Mild to Moderate Rosacea
As announced today by Bayer HealthCare, the U.S. Food& Drug Administration has approved Finacea Foam, 15% for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Finacea Foam was developed as part of a research and development collaboration between Foamix Pharmaceuticals Ltd. and Bayer HealthCare, utilizi
7/31/15 - KaloBios Pharmaceuticals receives approval from US FDA for KB003
KaloBios Pharmaceuticals, a biopharmaceutical company dedicated to improving the lives of patients with innovative therapies, has received approval from the US Food and Drug Administration for its investigational new drug application for KB003, an anti-GM-CSF monoclonal antibody, it was reported yesterday. The product is intended to treat patients.
7/31/15 - Mundipharma EDO GmbH Announces FDA Investigational New Drug Approval of its First Anti-Cancer Compound, EDO-S101, for the Treatment of Patients with Relapsed/Refractory Haematologic Malignancies and Solid Tumours
First in human clinical trials to commence Q3 2015. Mundipharma EDO GmbH is pleased to announce that the United States Food and Drug Administration has accepted the company's Investigational New Drug Application for EDO-S101, a fusion molecule to treat relapsed/refractory haematologic malignancies and solid tumours. Thomas Mehrling, MD, Ph.D, Manag
7/30/15 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; State Enforcement Notifications
SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled, "State Enforcement Notifications" has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995.. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville
7/30/15 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Veterinary Feed Directive
SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Veterinary Feed Directive" has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995.. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., CO
7/30/15 - Enanta Pharmaceuticals Gets U.S. Regulatory Approval of TECHNIVIE (ombitasvir, paritaprevir and ritonavir) Tablets [Professional Services Close - Up]
Enanta Pharmaceuticals reported that the U.S. Food and Drug Administration approved AbbVie's TECHNIVIE tablets in combination with ribavirin for the treatment of non-cirrhotic adults with genotype 4 chronic hepatitis C virus infection. Enanta said that Paritaprevir is its lead protease inhibitor identified within the ongoing Enanta-AbbVie...
7/30/15 - FDA Clears Way for Commercial Marketing of Sentrian Remote Patient Intelligence Solution
Sentrian, the Remote Patient Intelligence? company aspiring to eliminate all preventable hospitalization, recently received confirmation from the Food& Drug Administration that its Remote Patient Intelligence solution meets the definition of a "medical device" for which the FDA intends to exercise "Enforcement Discretion." The designation ident
7/30/15 - Ipsen Biopharmaceuticals, Inc. Announces FDA Approval of Dysport abobotulinumtoxinA for Injection in the Treatment of Upper Limb Spasticity in...
Ipsen Biopharmaceuticals, Inc. Announces FDA Approval of Dysport abobotulinumtoxinA for Injection in the Treatment of Upper Limb Spasticity in Adults in the United States. By a News Reporter-Staff News Editor at Politics& Government Week Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen, announced that the U.S. Food and Drug Administration
7/30/15 - Juno Announces FDA Clearance of Investigational New Drug Application for JCAR015 in Adult Relapsed/Refractory Acute Lymphoblastic Leukemia
Juno Therapeutics, Inc., a biopharmaceutical company focused on re-engaging the body's immune system to revolutionize the treatment of cancer, today announced the U.S. Food and Drug Administration cleared the Company's investigational new drug application for JCAR015 for treatment of adult patients with relapsed/refractory acute lymphoblastic...
7/30/15 - Neos Resubmits NDA for FDA Review of Orally Disintegrating Tablets; FDA Approves Deltoid Injection Site for Abilify Maintena
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 30, 2015.{ nfg} Neos Therapeutics, Inc., a pharmaceutical company with a late stage pipeline of innovative extended-release product candidates for the treatment of attention deficit hyperactivity disorder, today announced that it has resubmitte
7/30/15 - Teleflex : ARROW Endurance Extended Dwell PCS Gets FDA Market Clearance
WASHINGTON- Teleflex Inc., a provider of medical devices for critical care and surgery, said that its ARROW Endurance Extended Dwell Peripheral Catheter System received market clearance from the U.S. Food and Drug Administration or FDA. The new device is a peripheral catheter system in which the catheter is cleared by the FDA to dwell up to 29 days
7/30/15 - United States : FDA approves non-surgical temporary balloon device to treat obesity [TendersInfo (India)]
The U.S. Food and Drug Administration today approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System is intended to facilitate weight loss in obese adult patients. For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination o
7/29/15 - ARROW Endurance? Extended Dwell Peripheral Catheter System Receives FDA Market Clearance
Teleflex Incorporated, a global provider of medical devices for critical care and surgery, announced today that its ARROW Endurance? Extended Dwell Peripheral Catheter System received market clearance from the U.S. Food and Drug Administration. The ARROW Endurance? Extended Dwell Peripheral Catheter System is yet another offering from Telefl
7/29/15 - Bristol-Myers Squibb Secures FDA Approval of Daklinza [Manufacturing Close - Up]
Bristol-Myers Squibb Company reported that Daklinza, an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration. According to a release from the company, this approval marks the first time patients with chronic hepatitis C virus genotype 3 have a 12- week, once-daily, all-oral treatment option. "The U.S. appr
7/29/15 - C2 Therapeutics Receives FDA 510(k) Clearance for the Coldplay Cryoballoon? Full and Swipe Ablation Systems
C2 Therapeutics, a privately held company founded to improve treatment of precursors to esophageal cancer, today announced US Food and Drug Administration 510 clearance for the Coldplay Cryoballoon? Full Ablation System and the Coldplay Cryoballoon? Swipe Ablation System. The clearance of Coldplay Cryoballoon Full and Swipe Systems is an imp
7/29/15 - Corvida Medical Receives FDA 510(k) Clearance for HaloTM Closed System Transfer Device
Emerging medical device firm Corvida Medical has received a 510 clearance from the US Food and Drug Administration to market its first product, the Halo? Closed System Transfer Device, to protect health care professionals from exposure to hazardous drugs. The device received an ONB product code classification from the FDA, demonstrating no escape
7/29/15 - Deltex Says FDA Approves Release Of Its Paediatric Monitors In US
LONDON- Deltex Medical Group PLC said Wednesday the US Food and Drug Administration has approved the release of its paediatric probes in the US. It has been sold in Europe for the last ten years. We expect to generate first revenues in the second half of the year, "said Chief Executive Ewan Phillips in a statement.
7/29/15 - FDA approves balloon for weight loss
An inflatable balloon device has been approved by the Food and Drug Administration to help obese patients lose weight without surgery. Unlike LAP-band and gastric bypass, the new device, called the ReShape Dual Balloon, does not change the shape of the stomach. Ninh Nguyen, past president of the American Society for Metabolic and Bariatric Surgery,
7/29/15 - FDA approves non-surgical temporary balloon device to treat obesity
Release date- 28072015- The U.S. Food and Drug Administration today approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System is intended to facilitate weight loss in obese adult patients. 'For those with obesity, significant weight loss and maintenance of that weight loss often
7/29/15 - KaloBios Announces FDA Clearance of Investigational New Drug Application for KB003 in Patients with Chronic Myelomonocytic Leukemia
KaloBios Pharmaceuticals, Inc., a monoclonal antibody company focused on developing innovative therapies to benefit patients with diseases of unmet medical need, with a focus on oncology, announced today that the U.S. Food and Drug Administration has cleared the company's investigational new drug application for KB003, an anti-GM-CSF monoclonal a
7/29/15 - Recent Findings from Cornell University College of Medicine Provide New Insights into Weight Loss (Efficacy comparison of medications approved for...
Recent Findings from Cornell University College of Medicine Provide New Insights into Weight Loss. According to news reporting from New York City, New York, by NewsRx journalists, research stated, "For the first time, patients who are obese are able to benefit from 5 different FDA approved pharmacologic agents for chronic weight management.
7/29/15 - United States : FDA approves MEDICINOVA for Second MN-001 Protocol in NASH [TendersInfo (India)]
Medicinova has announced the getting of FDA approval for a second protocol for a clinical trial evaluating MN-001 for a NASH indication. Medicinova stated that this study focuses NASH patients with hypertriglyceridemia to estimate the ability of MN-001 for advancing cardiovascular risk by assessing cholesterol-efflux capacity and serum...
Articles(s): 1 - 25 of 59     Next >>     Go To Page:


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