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 The leading web portal for pharmacy resources, news, education and careers September 21, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - September 21, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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9/19/17 - C4 Imaging Announces an Additional FDA 510k Clearance for its Positive-Signal MRI Marker - Sirius
By a News Reporter-Staff News Editor at Cancer Weekly C4 Imaging LLC is pleased to announce an additional US Food and Drug Administration 510 clearance for its Sirius? MRI Marker, a novel positive-signal MRI Marker that is used during the treatment of prostate cancer with brachytherapy. This additional 510 clears Sirius? MRI Markers to be ste
9/19/17 - Corporate News Blog - Neos Therapeutics Receives FDA's Approval for Adzenys ER(TM) Extended-Release Oral Suspension, its Third Treatment for ADHD
LONDON, UK/ ACCESSWIRE/ September 19, 2017/ Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Neos Therapeutics, Inc., following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/? Presently, Neos Therapeutics is the only Company that offers both br
9/19/17 - Cycle Pharmaceuticals Receives FDA Approval and Launches Ketorolac Tromethamine Injection 30mg/mL in the U.S.
Ketorolac Tromethamine Injection has been developed in collaboration with Caplin Point Laboratories Ltd and is manufactured at their FDA approved site. After the successful launch of Nityr? tablets last month from our Orphan Drugs Division, we are proud to be announcing the first product from our Generics Division. said Steve Fuller, Head o
9/19/17 - FDA approves first biosimilar for the treatment of cancer
Release date- 18092017- The U.S. Food and Drug Administration today approved Mvasi as a biosimilar to Avastin for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer. 'Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high,
9/19/17 - FDA approves first medical app, for use in addiction [T-break Tech (Middle East)]
This is a defining moment for digital therapeutics and for patients with substance use disorder, said Corey McCann, President and Chief Executive Officer of Pear Therapeutics. As the first FDA- cleared Prescription Digital Therapeutic for disease treatment, reSET has demonstrated improved abstinence and treatment retention in a randomized controlle
9/19/17 - FDA approves new treatment for adults with relapsed follicular lymphoma
'For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,' said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.' Options are limited for these patien
9/19/17 - FDA Okays GSK's Three-in-one Drug Inhaler For COPD
LONDON- GlaxoSmithKline plc and Innoviva Inc. said that the US Food and Drug Administration has approved once-daily, single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol, under the brand name Trelegy Ellipta, for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease or COPD,...
9/19/17 - FDA OKs Glaxo's inhaler, first one to combine 3 medicines
The FDA late Monday approved sales of Trelegy Ellipta, developed jointly by GlaxoSmithKline PLC and Innoviva Inc. It contains three widely used types of medicine to prevent rather than treat flare-ups of the life-threatening breathing disorders. U.K.- based GlaxoSmithKline is launching Trelegy with a list price of $530 per month. That's $146
9/19/17 - Frost & Sullivan Recognizes Ventec Life Systems for New Product Innovation - Game-changing, Modular Respiratory System, VOCSN
Based on its recent analysis of the respiratory care market, Frost& Sullivan recognizes Ventec Life Systems with the 2017 North American Frost& Sullivan Award for New Product Innovation. Ventec Life Systems received Food and Drug Administration clearance for its portable unified respiratory system, VOCSN, in April 2017. The innovative product com
9/19/17 - Medtronic Announces FDA Approval and U.S. Launch of Next Generation Spinal Cord Stimulator for Chronic Pain Management [Algeria Press Service]
DUBLIN- September 18, 2017- Medtronic plc today announced FDA approval and U.S. launch of the Intellis (TM) platform for the management of certain types of chronic intractable pain. The Intellis platform can record and track patient activity 24/ 7 and is managed on the Samsung Galaxy Tab S2 tablet interface, enabling physicians to address the subje
9/19/17 - Medtronic Announces FDA Approval, U.S. Launch of Next Generation Spinal Cord Stimulator for Chronic Pain Management
Medtronic issued the following news release:. Medtronic plc today announced FDA approval and U.S. launch of the Intellis (TM) platform for the management of certain types of chronic intractable pain. The Intellis platform can record and track patient activity 24/ 7 and is managed on the Samsung Galaxy Tab S2 tablet interface, enabling physicians to
9/19/17 - Neos Therapeutics Receives U.S. FDA Approval of Adzenys ER Extended Release Oral Suspension for the Treatment of ADHD in Patients 6 Years and Older
Release date- 18092017- DALLAS and FORT WORTH- Neos Therapeutics, Inc., a pharmaceutical company focused on developing, manufacturing and commercializing innovative extended release products using its proprietary modified release drug delivery technologies, today announced that the U.S. Food and Drug Administration has approved Adzenys ER Extended.
9/19/17 - New indication for BRIVIACT UCB's newest antiepileptic drug approved by FDA as monotherapy treatment of partial onset seizures in adults
Release date- 18092017- Atlanta, Georgia& Brussels ( Belgium- 0700 (CEST): UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for BRIVIACT (brivaracetam) CV as monotherapy for partial onset (focal) seizures (POS) in patients 16 years and older with epilepsy.1. This is a new i
9/19/17 - Seqirus Receives FDA Approval of AFLURIA QUADRIVALENT for People Five Years of Age and Older in the U.S
AFLURIA QUADRIVALENT, which was first approved in the U.S. in August 2016 for people aged 18 and older, helps protect against two influenza A strain viruses and two B strain viruses.3, 10. The U.S. Centers for Disease Control and Prevention recommends annual influenza vaccination for everyone six months of age and older.6 Recently, the CDC' s Advis
9/19/17 - Sunovion's Aptiom Receives FDA Approval for Expanded Indication to Treat Partial Onset Seizures in Children and Adolescents 4 Years of Age and Older
Release date- 18092017- Marlborough, Mass.- Sunovion Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration approved the supplemental New Drug Application to expand the indication for its antiepileptic drug Aptiom to include treatment of partial onset seizures in children and adolescents four to 17 years of age.
9/19/17 - Teligent, Inc. Announces FDA Approval of Triamcinolone Acetonide Cream USP, 0.1%
Teligent, Inc., a New Jersey- based specialty generic pharmaceutical company, today announced it has received approval of the Company s abbreviated new drug application from the U.S. Food and Drug Administration of Triamcinolone Acetonide Cream USP, 0.1%. Triamcinolone Acetonide Cream USP, 0.1% is Teligent s fifth FDA approval in 2017,?
9/19/17 - Trelegy Ellipta Approved as the First Once-Daily Single Inhaler Triple Therapy for the Treatment of Appropriate P.atients With COPD in the US
GlaxoSmithKline issued the following news release:. GlaxoSmithKline plc and Innoviva, Inc. today announced that the US Food and Drug Administration has approved once-daily, single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol, under the brand name Trelegy Ellipta, for the long-term, once-daily, maintenance treatment of patients
9/19/17 - Trelegy Ellipta approved as the first once-daily single inhaler triple therapy for the treatment of appropriate patients with COPD in the US
GlaxoSmithKline plc and Innoviva, Inc. today announced that the US Food and Drug Administration has approved once-daily, single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol, under the brand name Trelegy Ellipta, for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease,...
9/19/17 - U.S. FDA Approves New Indication for Ipsen's Somatuline Depot Injection for the Treatment of Carcinoid Syndrome
Release date- 18092017- Ipsen, today announced that the U.S. Food and Drug Administration has approved a supplemental indication for Somatuline Depot Injection 120 mg for the treatment of carcinoid syndrome; when used, it reduces the frequency of short acting somatostatin analogue rescue therapy. Alexandre Lebeaut, MD, Executive Vice-President, R&D
9/19/17 - US FDA approves Amgen and Allergan`s Avastin biosimilar [Sport360]
Amgen developed Mvasi in collaboration with Allergan under a deal signed in 2010. An Amgen spokeswoman told us "In the collaboration with Allergan, Amgen has primary responsibility for the development, manufacture and initial commercialization of the products; whereas Allergan will provide funding over the course of development as well as expertise
9/18/17 - 5 Stocks To Watch For September 18, 2017
Wall Street expects Steelcase Inc. to post quarterly earnings at $0.23 per share on revenue of $759.83 million after the closing bell. Steelcase shares gained 1.79 percent to close at $14.25 on Friday. Neos Therapeutics Inc disclosed that it has received the FDA approval for Adzenys ER. Scorpio Tankers shares dropped 2.23 percent to close at $3.50
9/18/17 - BioPhotas Inc. Clears Additional FDA and Intellectual Property Hurdles
By a News Reporter-Staff News Editor at Clinical Trials Week BioPhotas, Inc. announced the FDA clearance of the Celluma, its award-winning and patented medical device, for an additional indication-for-use in treating full face wrinkles. The FDA has previously cleared the Celluma for eight separate indications-for-use, including the treatment of..
9/18/17 - Braeburn Announces FDA Acceptance with Priority Review of New Drug Application for CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder
Braeburn Pharmaceuticals, Inc. announces that the U.S. Food and Drug Administration has accepted its New Drug Application with Priority Review designation for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder. "FDA's acceptance of our NDA for CAM2038 under Priority R
9/18/17 - eNeura, Inc. Receives FDA Clearance for Use of SpringTMS for Migraine Prevention
By a News Reporter-Staff News Editor at Pharma Business Week eNeura, Inc., a privately held medical technology company, announced that it has obtained 510 clearance from the U.S. Food and Drug Administration that states: "The eNeura Spring TMS is indicated for the acute and prophylactic treatment of migraine headache." With this FDA clearance the
9/18/17 - FDA Approves Guerbet's Dotarem gadoterate meglumine for Pediatric Patients Younger Than Two Years
By a News Reporter-Staff News Editor at Pharma Business Week Guerbet LLC USA, the US affiliate of the global specialist in contrast products and solutions for medical imaging, announced that the US Food and Drug Administration has approved Dotarem for intravenous use with magnetic resonance imaging in pediatric patients under two years old, in
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