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 The leading web portal for pharmacy resources, news, education and careers April 23, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - April 23, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 51     Next >>     Go To Page:

4/23/17 - FDA approves drugs more quickly than peer agency in Europe
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA New Haven, Conn. The U.S. Food and Drug Administration reviews and approves new medicines in a shorter timeframe than its peer agency in Europe, the European Medicines Agency, says a Yale researcher. This finding, which comes at a time when the FDA is under renewed pressure
4/23/17 - FDA clears heart disease trial at Boston Children's Hospital using mesoblast's cell therapy
By a News Reporter-Staff News Editor at Heart Disease Weekly BOSTON, NEW YORK, and MELBOURNE, Australia, Boston Children's Hospital, the pediatric teaching hospital of Harvard University, and Mesoblast Limited announced that the United States Food and Drug Administration has cleared the commencement of a 24- patient trial combining Mesoblast's.
4/23/17 - TAGRISSO osimertinib Receives US FDA Full Approval
By a News Reporter-Staff News Editor at Heart Disease Weekly AstraZeneca announced that the US Food and Drug Administration has granted full approval for TAGRISSO 80 mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer, as detected by an FDA- ap
4/22/17 - FDA approves gammaCore for treatment of pain linked to cluster headache [T-break Tech (Middle East)]
This is the first FDA product release for electroCore in the U.S.. "Cluster headache is a rare, debilitating and difficult to treat disorder with few effective acute therapies, said Stephen Silberstein, MD, Director, Headache Center, Jefferson University, Philadelphia, PA." The FDA release of gammaCore is an important advance in the treatment of t
4/22/17 - Pharma Healthcare Newsletter April 17 to April 21, 2017 [India Infoline News Service]
This week, Pharma major Glenmark Pharma has received tentative approval from the United States Food& Drug Administration to sell Pradaxa Drug used to prevent blood clots. Top News. Unichem Laboratories Limited on Monday announced that for Piroxicam Capsules USP 10 mg& 20 mg, it has received ANDA approval from the United States Food and Drug A
4/22/17 - Rep. Stivers Introduces Speeding Access to Already Approved Pharmaceuticals Act
Steve Stivers, R- Ohio, has introduced the Speeding Access to Already Approved Pharmaceuticals Act to "require the Food and Drug Administration to expedite review of pharmaceuticals that are approved for marketing in the European Union." Steve Stivers in Washington at 1022 Longworth House Office Building, Washington, DC 20515; 202/ 225-2015; or in
4/21/17 - Cardiac Insight raises $4.5M, wins FDA approval to launch wearable ECG sensor [Tehran Times (Iran)]
Kirkland, Wash.- based Cardiac Insight is hoping to break into that market with Cardea Solo, a lightweight disposable electrocardiogram test that monitors a patients heartbeat. The company has raised $4.5 million to develop and commercialize the device and announced today that it has been approved for use by the FDA and is now available to healthca
4/21/17 - FDA approves 2nd near-copy of Remicade for immune disorders
The U.S. Food and Drug Administration approved Renflexis, developed by Samsung Bioepis Co. of South Korea. Its U.S. partner, Merck& Co. of Kenilworth, New Jersey, will market Renflexis. The first biosimilar for Remicade, Inflectra from New York- based Pfizer Inc., went on sale in November at a 15 percent discount.
4/21/17 - FDA Approves Device to Help Curb Cluster Headaches [Syrian Arab News Agency]
Cluster headaches, though rare, are among the most severe forms of headache a person can face. The U.S. Food and Drug Administration said it has approved a hand-held device to treat these attacks. "Although they are uncommon, affecting about 1 in 2,000, they are severe, disabling and poorly understood," said Rosen, who directs Northwell Health`s H
4/21/17 - FDA approves near-copy of Remicade for immune disorders
Federal regulators have approved an alternative version of Remicade, an expensive injected drug widely used for rheumatoid arthritis and other immune system disorders.
4/21/17 - IDC Receives Health Canada Approval for Aquarius DR Imaging Devices
Calgary, Alberta- Imaging Dynamics Company Ltd. is pleased to announce that it received notification that Health Canada has approved its Digital Radiography products- Aquarius 8600 1717 TC and Aquarius 8600 1417 TC for sale in Canada. These products were also approved by the United States Food and Drug Administration on February 22, 2017 for sales
4/21/17 - Mylan releases generic version of Trilafon
Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product, which is used in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults.Perphenazine tablets had U.S. sales of approximately $41 million for the 12 months ending Feb. 28, according t
4/21/17 - VOCSN By Ventec Life Systems Receives FDA 510(k) Clearance
Bothell, Wash-based Ventec Life Systems has received 510(k) clearance from the FDA for its VOCSN portable respiratory device for patients on a ventilator.
4/21/17 - Ziptek LLC Receives FDA Approval For ZipE, the Innovative Knotless Tissue Repair Device
Ziptek LLC, founded by accomplished orthopedic surgeon William Bennett M.D. of Bennett Orthopedics and Sports medicine, has obtained FDA approval for ZipE, the cutting edge knotless tissue repair device. Ziptek LLC, founded by Sarasota- based orthopedic surgeon Dr. Ziptek LLC exhibited at the March 2017 AAOS Meeting in San Diego and garnered signif
4/20/17 - Blog Coverage CytRx Announces FDA's Approval for New Drug Application
LONDON, UK/ ACCESSWIRE/ April 20, 2017/ Active Wall St. blog coverage looks at the headline from CytRx Corp. as the Company announced on April 19, 2017, that the US Food and Drug Administration has agreed to a rolling submission for a New Drug Application submission for the Company's aldoxorubicin drug for the treatment of soft tissue sarcomas.
4/20/17 - FDA hits the ground running with 12 first-quarter 2017 drug approvals [Syrian Arab News Agency]
After a big slowdown in 2016, FDA new drug approvals got off to a hot start in 2017. With 12 new drugs approved in the first quarter, FDA approval action this year bested any since 2011, according to the FDAs website. Another drug expected to make its U.S. debut with a 2017 FDA approval is PTC Therapeutics Emflaza, a decades-old steroid thats been
4/20/17 - Incubator effort leads to bone-graft material [The Blade, Toledo, Ohio]
April 20 OsteoNovus Inc., a biomedical startup that this week received federal regulatory approval for a new synthetic bone-graft material, is closing in on a deal that would jump- start sales and likely push the company to profitability before the end of the year. "getting a lot of companies excited about it and now we are excited we have the F
4/20/17 - UT incubator effort leads to bone-graft material [The Blade, Toledo, Ohio]
April 20 OsteoNovus Inc., a biomedical startup that this week received federal regulatory approval for a new synthetic bone-graft material, is closing in on a deal that would jump- start sales and likely push the company to profitability before the end of the year. "getting a lot of companies excited about it and now we are excited we have the F
4/19/17 - CytRx Announces FDA Agreement on Regulatory Pathway to Approval for Aldoxorubicin in Soft Tissue Sarcomas
CytRx Corporation today announced the U.S. Food and Drug Administration has reached an agreement with CytRx on preparations for a New Drug Application submission for aldoxorubicin in soft tissue sarcomas. "We are very pleased to have achieved clarity from the FDA regarding CytRx's soft tissue sarcoma program," said Daniel Levitt, MD, PhD, Chief
4/19/17 - Edwards' Advanced Hemodynamic Monitoring Platform Receives FDA Clearance
Edwards Lifesciences Corporation, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, has received FDA clearance for its HemoSphere advanced monitoring platform. "The HemoSphere advanced monitor enables simplified visual clinical support, which is particularly important in the care of our m
4/19/17 - FDA approves Roche's Lucentis (ranibizumab injection) for diabetic retinopathy, the leading cause of blindness among working age adults in the United States
-Granted Priority Review Designation by the FDA based on analysis of results from a National Institutes of Health- funded collaborative group study. Basel Roche today announced that the US Food and Drug Administration approved Lucentis 0.3 mg for the monthly treatment of withal forms of diabetic retinopathy. The FDA granted Lucentis Priority R
4/19/17 - FDA Grants Genentech's Tecentriq (Atezolizumab) Accelerated Approval as Initial Treatment for Certain People with Advanced Bladder Cancer
Release date- 17042017- South San Francisco, CA- Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration granted accelerated approval to TECENTRIQ for the treatment of people with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. 'We are pleased that TECEN
4/19/17 - FDA grants Roche's TECENTRIQ (atezolizumab) accelerated approval as initial treatment for certain people with advanced bladder cancer
Basel Roche today announced that the US Food and Drug Administration granted accelerated approval to TECENTRIQ for the treatment of people with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. "TECENTRIQ was the first cancer immunotherapy approved by the FDA for people with advanced bladder
4/19/17 - Genentech`s Tecentriq receives FDA-accelerated approval for advanced bladder cancer treatment [Sport360]
Roche Group member Genentech has received accelerated approval from the US Food and Drug Administration for Tecentriq to treat patients with locally advanced or metastatic urothelial carcinoma who are unable to undergo cisplatin chemotherapy. Tecentriq previously received approval to treat people with locally advanced or mUC showing disease...
4/19/17 - GNTbm to begin Phase III clinical trial in Taiwan of epigenetic regulator Chidamide for late-stage breast cancer
GNT Biotech& Medicals Co., Ltd., has announced that the anticancer drug Chidamide, an epigenetic regulator developed by Chipscreen Biosciences Ltd., of Shenzhen, China, had received approval from the Taiwan Food and Drug Administration to begin a Phase III clinical trial in Taiwan for hormone receptor-positive, HER-2 negative late stage breast ca
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