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 The leading web portal for pharmacy resources, news, education and careers September 20, 2018
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - September 20, 2018

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 54     Next >>     Go To Page:

9/19/18 - Global Parkinson's Disease Drugs Market 2018-2023: Recent Drug Approvals are Driving Growth
In January 2015, the US FDA approved an extended release formulation of levodopa/carbidopa. Recently in January 2018, Adamas Pharmaceuticals Inc. has launched Gocovri for the treatment of dyskinesia in people with Parkinson's, who are taking levodopa. -Generic Competition to Key Therapies- Restraining the Market.
9/19/18 - Global Parkinson's Disease Drugs Market 2018-2023: Recent Drug Approvals are Driving Growth - ResearchAndMarkets.com
In January 2015, the US FDA approved an extended release formulation of levodopa/carbidopa. Recently in January 2018, Adamas Pharmaceuticals Inc. has launched Gocovri for the treatment of dyskinesia in people with Parkinson's, who are taking levodopa. Key Highlights Generic Competition to Key Therapies- Restraining the Market Europe Holds the Large
9/19/18 - Teva Announces U.S. Approval of AJOVYTM Injection, the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing
JERUSALEM- Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration has approved AJOVYTM injection for the preventive treatment of migraine in adults. Migraine is a disabling neurological disease that affects more than 36 million people in the United States,' said Stephen Silberstein, MD, Director, Jefferson He
9/19/18 - UTILITY Receives Investigational New Drug Approval from US FDA
UTILITY therapeutics Ltd, a pharmaceutical company focused on developing and commercialising antibiotics in the US, today announces that the US Food and Drug Administration has approved the Investigational New Drug applications for mecillinam and pivmecillinam. In May 2018 UTILITY announced the signature of an exclusive license agreement for the...
9/18/18 - AstraZeneca - US FDA approves LUMOXITI for certain patients with relapsed or refractory hairy cell leukemia
AstraZeneca and MedImmune, its global biologics research and development arm, announced today that the US Food and Drug Administration has approved LUMOXITI for the treatment of adult patients with relapsed or refractory hairy cell leukemia who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.
9/18/18 - FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis, a Rare Form of Juvenile Arthritis
South San Francisco- Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration has approved the subcutaneous formulation of Actemra for the treatment of active systemic juvenile idiopathic arthritis in patients two years of age and older. 'Systemic juvenile idiopathic arthritis is a rare, debilitating diseas
9/18/18 - Halozyme Announces Approval Of Subcutaneous Formulation Of Trastuzumab (Herceptin) In Canada [Tehran Times (Iran)]
Halozyme Therapeutics, Inc. today announced that Roche has received approval from Health Canada for a subcutaneous formulation of trastuzumab for the treatment of patients with HER2-positive breast cancer. "We are pleased that the subcutaneous formulation of trastuzumab has been approved in Canada," said Dr. The U.S. Food and Drug Administration a
9/18/18 - inui Health Announces the First Clinical Grade Diagnostics Test Accessible to Everyone, Anywhere in the World, From Their Smartphone
inui? Health, a Silicon Valley digital health company, announced the launch of its flagship diagnostics in-home urine analysis platform. The diagnostic platform, which includes a disposable test and smartphone app, has received 510 clearance and a Clinical Laboratory Improvements Amendments waiver from the U.S. Food and Drug Administration, plus
9/18/18 - Lice Clinics of America - Oklahoma City Expands Footprint to Norman
As a salon owner, Amanda Westerman is aware of the problem families have with head lice, but things got serious when she was confronted by the pests in her own family. After struggling with head lice and discovering that traditional products are no longer effective, I found out about Lice Clinics of America and the AirAll medical devic
9/18/18 - Southern Implants Advanced Dental Implant System PROVATA? Now Available in the U.S.
Southern Implants North America today received FDA 510 clearance for its innovative internal hex dental implant system, PROVATA, making the product offering commercially available for sale in the U.S. for the first time. "Our goal introducing the PROVATA to the North American market helps unite both the external and internal hex treatment option
9/18/18 - Sun wins approval of glaucoma drug and its once-troubled Halol plant to produce it [Syrian Arab News Agency]
Indias Sun Pharmaceuticals, which is working hard to shift its focus from generic to novel and specialty drugs, has won FDA approval of a new treatment for glaucoma. The drug will be made at Suns once-troubled Halol plant, indicating that problems there have been resolved after nearly four years. As the only BAK-free version of latanoprost, XELPROS
9/18/18 - U.S. FDA Clears Sebacia Microparticles for the Treatment of Mild to Moderate Inflammatory Acne [T-break Tech (Middle East)]
Sebacia, Inc., a privately held, commercial stage dermatology and aesthetics company, today announced that the U.S. Food and Drug Administration has granted clearance for its lead product, Sebacia Microparticles. In the U.S., Sebacia Microparticles is indicated for use as an accessory to 1064 nm lasers to facilitate photothermal heating of sebaceou
9/17/18 - Anti-migraine Head Patch - HeadaTerm - Receives FDA Clearance
WAT Medical's innovative technology to treat all primary headach es, HeadaTerm, received its FDA clearance in September 2018. This product, already approved by CE, HC, and now FDA, has been distributed in over 20 countries around the world. Professor Mourad Tayebi, who specializes in Biomedical Sciences at the School of Medicine at Western Sydney
9/17/18 - Baxter Announces U.S. FDA Clearance of New Bone Graft Substitute, Actifuse Flow
By a News Reporter-Staff News Editor at Pharma Business Week Baxter International Inc., a global leader in advancing surgical innovation, announced U.S. Food and Drug Administration clearance of Actifuse Flow Bone Graft Substitute for use in a variety of orthopedic surgical procedures. As the newest addition to Baxter's growing osteobiologics sur
9/17/18 - BIOTRONIK wins US FDA approval for PK Papyrus stent for the treatment of coronary perforations in the US
Medical technology company BIOTRONIK reported on Friday the receipt of US FDA approval for the PK Papyrus covered coronary stent system under Humanitarian Device Exemption for use in the emergency treatment of acute coronary perforations. Based on the company's ultrathin stent platform technology, PK Papyrus is the first US FDA approved device for
9/17/18 - BTG plc - FDA Approves CroFab Product Improvements
BTG plc announced that the US Food& Drug Administration has approved updating the shelf life of CroFab Crotalidae Polyvalent Immune Fab to 60 months and the removal of mercury from the product's manufacturing process. The changes are part of the third update to the CroFabPrescribing Information in three years. 'BTG continues to make investments in
9/17/18 - CytoSorbents REFRESH 2-AKI Protocol Amendment Approved by FDA
By a News Reporter-Staff News Editor at Pharma Business Week CytoSorbents Corporation a critical care immunotherapy leader using its CytoSorb blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that the REFRESH 2- AKI trial protocol amendment that was discussed i
9/17/18 - Evonik - TROGAMID CX MOLDING COMPOUND APPROVED FOR FOOD CONTACT IN THE USA
The U.S. Food and Drug Administration has issued a so-called Food Contact Notification to approve Evonik's microcrystalline polyamide TROGAMID CX 7323 for food contact. This enables the specialty chemicals company to offer a transparent, high-performance polymer with excellent temperature and chemicals resistance as a bisphenol-A- free material...
9/17/18 - FDA Approves Clinical Trial to Test Treating Fibromyalgia With TB Vaccine [Syrian Arab News Agency]
With the recent approval of the U.S. Food and Drug Administration, a human clinical trial is set to begin on BCG, a vaccine typically used to prevent tuberculosis, to treat fibromyalgia. BCG, or Bacillus Calmette-Guerin, has been used since 1921 as a TB vaccine in countries with a high prevalence of TB. The trial is funded by EpicGenetics, a biomed
9/17/18 - FDA Approves New Treatment for Hairy Cell Leukemia [Sudan Tribune]
On Sept. 13, 2018, FDA announced it approved AstraZenecas Lumoxiti injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti fills an unmet need for patients with hairy cell l
9/17/18 - FDA approves Teva's Ajovy, second CGRP inhibitor to prevent migraine
FDA approved Ajovy fremanezumab-vfrm from Teva Pharmaceuticals Industries Ltd. to prevent migraine in adults. Teva said it expects monthly and quarterly injectable doses of Ajovy to be available within two weeks at a wholesale acquisition cost of $575 and $1,725, respectively. In May, FDA approved the first CGRP inhibitor to prevent migraine Aimo
9/17/18 - Medical Society Files FDA Citizen Petition Seeking Removal of Boxed Warnings on Ultrasound Contrast Agents
According to the International Contrast Ultrasound Society, UCAs are radiation-free diagnostic imaging agents that enhance the clarity and reliability of front-line ultrasound scans and often reduce the need for more expensive downstream testing. Three UCAs are currently approved for use in the United States Definity, Lumason and Optison.
9/17/18 - Mid-Morning Market Update: Markets Mostly Lower; Teva's Preventive Migraine Treatment Approved By FDA
Meanwhile, top gainers in the sector included Apergy Corporation up 4 percent, and Evolution Petroleum Corporation up 5 percent. Teva Pharmaceutical Industries Ltd ADR has struggled amid sagging sales of its blockbuster multiple sclerosis treatment Capaxone due to a generic launch in 2017 and its debt burden following the purchase of Allergan plc
9/17/18 - Movement Disorder Market Expected to Represent a Value of over US$ 1,000 Mn by 2026: Medications and treatments approved by FDA is also expected to impact growth of the global movement disorder market. Xadago (safinamide) tablets and Ingrezza capsule
Rockville, WA 09/17/2018 Growing prevalence of neurological diseases has led to surge in demand for managing mental disorders. In addition, Manufacturers are increasingly focusing on incorporating advanced features in the medical devices for the treatment of the neurological diseases, which is projected to impact the global market growth of m
9/17/18 - Oramed Receives FDA Clearance for IND Application for Its Oral GLP-1 Analog Capsule
Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for human trials of its oral GLP-1 analog capsule ORMD-0901. Oramed Pharmaceuticals is a technology pioneer i
Articles(s): 1 - 25 of 54     Next >>     Go To Page:


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