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 The leading web portal for pharmacy resources, news, education and careers February 19, 2018
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - February 19, 2018

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 86     Next >>     Go To Page:

2/19/18 - AstraZeneca's IMFINZI approved for Stage III nsclc
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
2/19/18 - AstraZeneca: Imfinzi Receives FDA Approval To Treat Unresectable Stage III NSCLC
LONDON- AstraZeneca PLC and MedImmune announced the. US FDA has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval is based on the positive PFS data from the Phase III PACIFIC trial
2/19/18 - Embrace by Empatica is the world's first smart watch to be cleared by FDA for use in Neurology
By a News Reporter-Staff News Editor at Clinical Trials Week Empatica Inc has received clearance from the FDA for Embrace, its award-winning smart watch. Embrace uses AI to monitor for the most dangerous kinds of seizures, known as "grand mal" or "generalized tonic-clonic" seizures, and send an alert to summon caregivers' help. In a multi-site cl
2/19/18 - Grifols HyperRAB rabies immune globulin [human] 300 IU/mL Receives FDA Approval to Treat Patients Exposed to Rabies Virus Infection
By a News Reporter-Staff News Editor at Pharma Business Week Grifols, a leading global producer of plasma-derived medicines and provider of a variety of postexposure prophylaxis and immune globulin products for patients, has received approval from the U.S. Food& Drug Administration for a new higher potency formulation of its HyperRAB rabies im
2/19/18 - Novartis receives FDA approval for Cosentyx label update to include moderate to severe scalp psoriasis
By a News Reporter-Staff News Editor at Pharma Business Week Novartis announced that the US Food and Drug Administration has approved a label update for Cosentyx , the first interleukin-17A antagonist approved to treat moderate to severe plaque psoriasis.1 The updated label includes Cosentyx data in moderate to severe scalp psoriasis- one of th
2/19/18 - Novo Nordisk Launches Ozempic and Fiasp, Expanding Treatment Options for Adults with Diabetes
By a News Reporter-Staff News Editor at Clinical Trials Week Novo Nordisk announced the availability of two new diabetes medications, Ozempic injection 0.5 mg or 1 mg and Fiasp 100 Units/mL at pharmacies across the United States. Both medications received approval from the U.S. Food and Drug Administration in 2017 and represent the latest a
2/19/18 - Trethera Corporation Announces FDA Clearance of Investigational New Drug Application for TRE-515
By a News Reporter-Staff News Editor at Pharma Business Week Trethera Corporation, a biopharmaceutical company committed to developing novel drugs targeting cellular nucleotide metabolism for the treatment of cancer, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for TRE-515, a novel,...
2/19/18 - U.S. FDA Approves NorthStar Medical Radioisotopes' RadioGenixTM System Technetium Tc 99m Generator for Non-uranium Sourced Molybdenum-99 Mo-99...
By a News Reporter-Staff News Editor at Pharma Business Week NorthStar Medical Radioisotopes, LLC, a company involved in the production and distribution of radioisotopes used for medical imaging, announced that the U.S. Food and Drug Administration has approved the RadioGenixTM System, an innovative, high tech radioisotope separation platform ind
2/19/18 - U.S. Food and Drug Administration Approves Gilead's Biktarvy Bictegravir, Emtricitabine, Tenofovir Alafenamide for Treatment of HIV-1 Infection
By a News Reporter-Staff News Editor at Pharma Business Week Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration has approved Biktarvy , a once-daily single tablet regimen for the treatment of HIV-1 infection. Biktarvy has a Boxed Warning in its product label regarding the risk of post treatment acute exacerbation of hepa
2/19/18 - US FDA approves Imfinzi for unresectable Stage III non-small cell lung cancer
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
2/17/18 - Antares and AMAG surge after FDA approves jointly developed injector [Syrian Arab News Agency]
The US Food and Drug Administration has approved Antares Pharma Incs supplemental new drug application for the Makena auto-injector drug device. Todays announcement represents the first FDA approval of a drug-device combination product utilizing our QuickShot auto injector, said Robert Apple, the president and chief executive officer of Antares.
2/17/18 - FDA Approves Expanded Treatment Window for Clot Retrieval Device in Acute Ischemic Stroke [Syrian Arab News Agency]
The US FDA has approved the use of the Trevo clot retrieval device for up to 24 hours after symptom onset in certain patients presenting with acute ischemic stroke. The device, which is indicated as intial therapy for ischemic stroke when used in conjunction with tissue plasminogen activator, was previously approved for use within 6 hours of sympto
2/17/18 - US FDA APPROVES IMFINZI (DURVALUMAB) FOR UNRESECTABLE STAGE III NON-SMALL CELL LUNG CANCER
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration has approved IMFINZI for the treatment of patients with unresectable Stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
2/16/18 - Agios Receives FDA Priority Review for New Drug Application: How are Gene Therapy Drug Approvals Impacting Stocks?
Genetic therapy could be one of the strongest methods to target disease and cancer treatments. Agios Pharmaceuticals a big pharma company focused on cancer metabolism, rare genetic diseases, and metabolic immuno-oncology announced on February 14 the FDA granted priority review for their NDA. The company expects it will hear back about this NDA by A
2/16/18 - AMAG Pharmaceuticals Announces FDA Approval of Makena Subcutaneous Auto-Injector to Reduce the Risk of Preterm Birth in Certain At-Risk Women
WALTHAM- AMAG Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration approved the Makena subcutaneous auto-injector drug-device combination product as a ready-to-administer treatment to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in the past.
2/16/18 - Antares Pharma Announces FDA Approval of Partner`s Product Utilizing Our QuickShot Auto Injector [Sudan Tribune]
Antares Pharma, Inc. today announced the successful regulatory outcome of the Makena subcutaneous auto injector collaboration with AMAG Pharmaceuticals. This first pass approval was made possible through an excellent working collaboration with our device team and the development group at AMAG, ` said Robert F. Apple, President and Chief Executive..
2/16/18 - FDA Approves Another New Generic Form of 40mg Copaxone
The National Multiple Sclerosis Society issued the following news:. The approval means that Sandoz provided evidence that the generic medication is equivalent to the brand-name Copaxone. More Details: The FDA has approved a generic glatiramer acetate medication that has been shown to be equivalent to the 40 mg Copaxone taken three days per week by.
2/16/18 - FDA approves first blood test for concussion [T-break Tech (Middle East)]
The US Food and Drug Administration has, for the first time, approved a blood test to help detect concussion in adults. The Brain Trauma Indicator test measures two biomarkers: proteins known as UCH-L1 and GFAP that are released upon injury to the brain and pass through the blood-brain barrier. Its expensive; its not terrific, said Hank Nordhoff, c
2/16/18 - FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint
This is the first FDA- approved treatment for non-metastatic, castration-resistant prostate cancer. 'The FDA evaluates a variety of methods that measure a drug's effect, called endpoints, in the approval of oncology drugs. This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not sp
2/16/18 - Indego Exoskeleton Receives U.S. Regulatory Clearance for Stroke Treatment
Parker Hannifin Corporation, the global leader in motion and control technologies, today announced that the U.S. Food and Drug Administration has given additional clearance to market and sell the Indego exoskeleton for use in the treatment of individuals with hemiplegia due to stroke. "We are excited that Indego is now available for a much larger
2/16/18 - Indego Exoskeleton Receives U.S. Regulatory Clearance for Stroke Treatment [Tehran Times (Iran)]
-Parker Hannifin Corporation, the global leader in motion and control technologies, today announced that the U.S. Food and Drug Administration has given additional clearance to market and sell the Indego exoskeleton for use in the treatment of individuals with hemiplegia due to stroke. We are excited that Indego is now available for a much largernu
2/16/18 - Indego Exoskeleton Receives U.S. Regulatory Clearance for Stroke Treatment; Indego becomes the broadest available exoskeleton in the U.S. for gait therapy and personal use; clearance greatly expands the number of potential patients who can use exoske
CLEVELAND- Parker Hannifin Corporation, the global leader in motion and control technologies, today announced that the U.S. Food and Drug Administration has given additional clearance to market and sell the Indego exoskeleton for use in the treatment of individuals with hemiplegia due to stroke. 'We are excited that Indego is now available for a mu
2/16/18 - J&J gets quick approval for new next-gen prostate cancer drug [Arab News (Saudi Arabia)]
The FDA has approved Johnson& Johnsons next generation prostate cancer drug, apalutamide in an early but tough to treat form of prostate cancer that has not spread. The FDA has approved Erleada for patients with non-metastatic castration-resistant prostate cancer and is the first drug to reach market for these patients, who have no treatment option
2/16/18 - Lupin launches generic Tamiflu in the US
Mumbai, Baltimore- Pharma major Lupin announced the launch of its Oseltamivir Phosphate Capsules, USP having received an approval from the United States Food and Drug Administration earlier. Lupin's Oseltamivir Phosphate Capsules, USP, 30 mg, 45 mg, and 75 mg are the generic equivalent of Hoffman-La Roche, Inc.' s Tamiflu Capsules, 30 mg, 45 mg, an
2/16/18 - Masimo Announces FDA Clearance of Next Generation SedLine Brain Function Monitoring
By a News Reporter-Staff News Editor at Health& Medicine Week Masimo announced FDA clearance of Next Generation SedLine brain function monitoring. Emery Brown, MD, PhD, and Dr. Patrick Purdon, PhD, Director and Associate Director, respectively, of the Neuroscience Statistics Research Lab at Massachusetts General Hospital.
Articles(s): 1 - 25 of 86     Next >>     Go To Page:


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