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 The leading web portal for pharmacy resources, news, education and careers September 19, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - September 19, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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9/19/17 - Agilent Announces Expanded Use of Cancer Diagnostic in the United States; .Dako PD-L1 IHC 28-8 PharmDx Approved for Two New Indications
SANTA CLARA, Calif. Agilent Technologies Inc. today announced that the U.S. Food and Drug Administration has approved the cancer diagnostic known as PD-L1 IHC 28-8 pharmDx for use in cases of urothelial carcinoma and of squamous cell carcinoma of the head and neck. The PDL1 IHC 28-8 pharmDx test enables physicians in the USA to identify which pat
9/19/17 - Agilent Obtains U.S. FDA Approval for GenetiSure Dx Postnatal Assay
SANTA CLARA, Calif.- Agilent Technologies Inc. has announced that it has obtained 510 clearance from the U.S. Food and Drug Administration for the GenetiSure Dx Postnatal Assay: its first comparative genomic hybridization assay for diagnostic use. Previously available only in Europe, U.S. clinical genetic scientists can now use this assay to help i
9/19/17 - Amgen and Allergans anti-cancer biosimilar Mvasi receives FDA approval [All Iraq News Agency (AIN)]
Co-developed by Amgen and Allergan, Mvasi is the first anti-cancer biosimilar to be approved by the FDA and is largely similar to Avastin. Amgen research and development executive vice-president Dr Sean E. Harper said: The approval of Mvasi marks a significant milestone for healthcare practitioners and patients as the first anti-cancer biosimilar..
9/19/17 - Arkis BioSciences Achieves FDA Clearance of its CerebroFlo? EVD Catheter with Endexo Technology
Arkis BioSciences, a leading innovator in minimally invasive surgical instrumentation, has obtained FDA clearance of its new external ventricular drainage catheter, CerebroFlo?. Seaver says Arkis plans to introduce the device to the U.S. market at the upcoming annual Congress of Neurological Surgeons, which will be held in Boston, MA, Oct. 7-11
9/19/17 - Bayer receives FDA approval for Copanlisib in adults with relapsed follicular lymphoma after two prior systemic therapies
Release date- 18092017- Berlin- Bayer announced today that the U.S. Food and Drug Administration has approved copanlisib under the brand name Aliqopa 60 mg vial for injection for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. The FDA granted approval under the accelerated a
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
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