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 The leading web portal for pharmacy resources, news, education and careers August 18, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - August 18, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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7/19/17 - EIT Emerging Implant Technologies Announces 510(k) Approval from the FDA for Full 3D Printed Cage Portfolio and Begins Commercialization Process in the United States. [Syrian Arab News Agency]
Emerging Implant Technologies GmbH, a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that it has received full approval from the FDA to commercialize its spinal interbody product offerings for ALIF, TLIF, PLIF and Cervical procedures.
7/19/17 - FDA Approves Vosevi for Hepatitis C
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past, "said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation a
7/19/17 - Senate Subcommittee Approves FY2018 Agriculture Appropriations Bill
John Hoeven, R- N.D., chairman of the Senate Appropriations subcommittee on Agriculture Appropriations, issued the following news release:. The Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies today approved a $145.4 billion appropriations bill to support federal agriculture an
7/18/17 - Bayer gets domestic approval for liver cancer drug [Tehran Times (Iran)]
During a media event to commemorate both the recent domestic and overseas approval, the company said Korea is the second country in Asia to sell the drug on the market, following Japan. The domestic approval is another success for the company as another Bayer drug, Nexavar gained FDA approval for treating colorectal cancer drug as a first-line trea
7/18/17 - Cadila Healthcare may gain after getting USFDA approval for drug [Sudan Tribune]
Cadila Healthcare announced that it has received the tentative approval from the United States Food and Drug Administration to market Fingolimod Capsules, 0.5 mg. Among prominent companies, ACC and Jubilant FoodWorks will announce April- June 2017 results today, 17 July 2017. Suzlon Energy announced on Saturday, 15 July 2017, the filing of voluntar
7/18/17 - EIT Emerging Implant Technologies Announces 510(k) Approval from the FDA for Full 3D Printed Cage Portfolio and Begins Commercialization Process in the United States.
Emerging Implant Technologies GmbH, a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that it has received full approval from the FDA to commercialize its spinal interbody product offerings for ALIF, TLIF, PLIF and Cervical procedures.
7/18/17 - FDA approves Nerlynx to reduce risk of recurrent breast cancer
The U.S. Food and Drug Administration today approved the use of Nerlynx to treat early-stage HER2-positive breast cancer to lower remission risk. Breast cancer is the most common form of cancer in the United States with the National Cancer Institute, or NCI, estimates 252,710 women will be diagnosed with breast cancer in 2017 and 40,610 will die of
7/18/17 - FDA approves Vosevi for Hepatitis C
The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus genotypes 1-6 without cirrhosis or with mild cirrhosis. Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past, "said Edward Cox, M.D., director of the Office of Antimicrobial Pr
7/18/17 - FDA clears Philips` light therapy wearable for mild psoriasis [Arab Finance (Egypt)]
Philips scored FDA clearance for its wearable light therapy device for the treatment of psoriasis. The chronic disease affects more than 6.7 million adults in the U.S., according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The following year, the company earned a CE mark for the devices follow-up, which was introdu
7/18/17 - Insulia receives FDA clearance and CE mark to integrate Toujeo
This morning, Voluntis announced that Insulia , its digital companion for people with Type 2 diabetes, has received FDA clearance and the CE mark to integrate Toujeo . Insulia already received FDA clearance and the CE mark for insulins Lantus and Levemir in 2016. Insulia launched in the United States this month and will launch sho
7/18/17 - Janssen Biotechs Tremfya receives FDA approval for plaque psoriasis treatment [Arab Finance (Egypt)]
The US Food and Drug Administration has granted approval for Janssen Biotechs Tremfya to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Patients following systemic therapy may benefit from taking injections or pills, while the ones undergoing phototherapy receive treatment using...
7/18/17 - Puma Biotechnology Boosted After FDA Approves Breast Cancer Therapy
The U.S. Food and Drug Administration on Monday approved Puma Biotechnology Inc' s NERLYNX, formerly known as PB272, for the treatment of breast cancer. Neratinib is the first anti-HER2 treatment to gain the FDA' s approval for extended adjuvant therapy for early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, Puma..
7/18/17 - Senate Subcommittee Approves FY2018 Agriculture Appropriations Bill
WASHINGTON, D.C.- The Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies today approved a $145.4 billion appropriations bill to support federal agriculture and nutrition programs in FY2018. The FY2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agenc
7/18/17 - SUMMARY: Senate Subcommittee Approves FY2018 Agriculture Appropriations Bill
WASHINGTON- The fiscal year 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill provides a total discretionary funding level of $20.525 billion, which is $352 million below the fiscal year 2017 enacted level and $4.8 billion above the President's request. U.S. Senator Jeff Merkley, Ranking Member of the Agri
7/18/17 - U.S. Food and Drug Administration Approves Gilead's Vosevi? (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved Vosevi? tablets, a single-tablet regimen for the re-treatment of chronic hepatitis C virus infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1 a or 3 previously treated wit
7/17/17 - "Cardiologs ECG Analysis Platform" Receives FDA Clearance
By a News Reporter-Staff News Editor at Cardiovascular Week Cardiologs Technologies SAS announced that it has received FDA clearance of its Cardiologs ECG Analysis Platform, a cloud-based cardiac monitoring-analysis web service powered by artificial intelligence. The Cardiologs system is also CE-marked in Europe. Arnaud Rosier, cardiac...
7/17/17 - Bristol-Myers Squibb's ORENCIA abatacept Receives FDA Approval for Treatment of Active Psoriatic Arthritis PsA in Adults
By a News Reporter-Staff News Editor at Biotech Business Week Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration has approved ORENCIA for the treatment of adults with active Psoriatic Arthritis 1, a chronic2, inflammatory disease that can affect both the skin and musculoskeletal system.3 ORENCIA is approved and available
7/17/17 - FDA approves new treatment to reduce the risk of breast cancer returning
The U.S. Food and Drug Administration today approved Nerlynx for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. "HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan," said Richard Pazdur, M.D., director of the FDA
7/17/17 - FDA Clears SaeboVR Virtual ADL Rehabilitation System
SaeboVR, a virtual ADL (activities of daily living) rehabilitation system designed to provide real-life challenges to help neurological patients rehabilitate their upper extremities, has recently received clearance from the US Food and Drug Administration.
7/17/17 - GLENMARK PHARMA GETS USFDA NOD FOR HYPERTENSION MEDICINE
Glenmark Pharmaceuticals has received final approval from the US health regulator for Amlodipine and Olmesartan Medoxomil tablets, used in the treatment of hypertension. Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food and Drug Administration for Amlodipine and Olmesartan Medoxomil tablets, 5 mg/20 mg,
7/17/17 - Impax Announces FDA Approval of its AB Rated Generic Concerta (Methylphenidate Hydrochloride) Extended-Release Tablets CII
Impax Laboratories, Inc., a specialty pharmaceutical company, today announced it has received an AB therapeutic equivalent rating and final U.S. Food and Drug Administration approval on its Abbreviated New Drug Application for a generic version of Concerta Extended-Release tablets USP CII, 18, 27, 36 and 54 mg. "Approval of our AB-rated gener
7/17/17 - Perrigo Announces FDA Final Approval For Its First-To-File Ab Rated Generic Version Of Androgel Topical Gel, 1.62% Packets
Perrigo Company plc today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing AbbVie Inc.' s Androgel Topical Gel, 1.62% packets. Annual market sales for Androgel Topical Gel, 1.62% packets for the 12 months ending May 2017 were approximately $88 m
7/17/17 - Syngenta Receives China Import Approval for Agrisure Duracade Corn Trait
Syngenta announced today that it has received notification of import approval from the Chinese Ministry of Agriculture for its Agrisure Duracade trait. The Agrisure Duracade trait has completed the Food and Drug Administration consultation process, received registration from the Environmental Protection Agency and has been fully deregulated by..
7/17/17 - U.S. Food and Drug Administration Approves Puma's NERLYNX? (neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
Puma Biotechnology, Inc. today announced that the U.S. Food and Drug Administration has approved NERLYNX?, formerly known as PB272, a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy.
7/14/17 - Amgen Receives FDA Approval For BLINCYTO [All Iraq News Agency (AIN)]
Today, Amgen announced that it had received FDA approval for its drug BLINCYTO. The FDA had approved the Supplemental Biologics License Application sBLA for BLINCYTO, because of results from two positive clinical trials. The drug was approved because of results from a phase 3 study, known as the TOWER study.
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