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 The leading web portal for pharmacy resources, news, education and careers January 22, 2019
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - January 22, 2019

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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12/31/18 - FDA approves treatmentfor Parkinson's symptom FDA approves focused ultrasound to treat symptom of Parkinson's
The Food and Drug Administration has approved focused ultrasound as a treatment for a symptom of Parkinson's disease, opening up the pioneering treatment for widespread use. Studies at the University of Virginia, which partners with the Charlottesville- based Focused Ultrasound Foundation, laid the groundwork for the approval. The approval was base
12/31/18 - U.S. Food and Drug Administration Approves Portola Pharmaceuticals Prior Approval Supplement for Andexxa Generation 2 Manufacturing Process
Portola Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved the Company s Prior Approval Supplement for its large-scale, second generation Andexxa , allowing for broad commercial launch in the United States. Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations and was i
12/29/18 - Edwards Lifesciences SAPIEN 3 Ultra Transcatheter Heart Valve Receives FDA Approval
Edwards Lifesciences issued the following news release:. Edwards Lifesciences Corporation, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the SAPIEN 3 Ultra system has received U.S. Food and Drug Administration approval for transcatheter aortic valve replacement in...
12/28/18 - CathWorks FFRangio? System Receives U.S. FDA Clearance
By a News Reporter-Staff News Editor at Health& Medicine Week CathWorks announced that its FFRangio? System received United States Food& Drug Administration 510 clearance. The FFRangio system demonstrated accuracy versus the invasive FFR wire in a blinded comparative study, FAST-FFR. Jim Corbett, CathWorks CEO said, "The FDA clearance of CathWo
12/28/18 - Edwards' SAPIEN 3 Ultra Transcatheter Heart Valve Receives FDA Approval
IRVINE, Calif., Dec. 28, 2018/ PRNewswire/ Edwards Lifesciences Corporation, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the SAPIEN 3 Ultra system has received U.S. Food and Drug Administration approval for transcatheter aortic valve replacement in severe, sympto
12/28/18 - EhmetDx Receives FDA Approval Letter for X-Ray CBCT 510k Submission
By a News Reporter-Staff News Editor at Pharma Business Week EhmetDx announced that the company has received 510 clearance from the U.S. Food and Drug Administration for its innovative 3 D CBCT positioning software to be used in patient treatment at the McLaren Proton Therapy Center. The system is used to precisely guide the position of the proto
12/28/18 - FDA Approves Inhaled Parkinson`s Drug Just Before Government Shutdown [Tehran Times (Iran)]
The US Food and Drug Administration approved levodopa inhalation powder as a first-of-its-kind intermittent therapy for off episodes in patients with PD currently being treated with carbidopa/levodopa. Drug maker Acorda Therapeutics received word of its approval on the evening of December 21 just prior to the government shutdown taking place at...
12/28/18 - FDA Approves New Indication for ENVARSUS XR tacrolimus extended-release tablets
By a News Reporter-Staff News Editor at Pharma Business Week Veloxis Pharmaceuticals announced that the U.S. Food& Drug Administration approved a new indication for Envarsus XR to prevent organ rejection in de novo kidney transplant patients in combination with other immunosuppressants. This indication is commonly referred to as the de novo indic
12/28/18 - FDA Approves Nplate Romiplostim For Use In Pediatric Patients With Immune Thrombocytopenia
By a News Reporter-Staff News Editor at Pharma Business Week Amgen announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application for Nplate for the treatment of pediatric patients one year of age and older with immune thrombocytopenia for at least six months who have had an insufficient respon
12/28/18 - Federally approved cannabis drug offers hope for patients and marijuana advocates [Syrian Arab News Agency]
The drug meant another chance at treating their 10- year-old son Zachs ongoing seizures, and a possibility for broader medical cannabis access in Texas. Successful clinical trials, including some with Texas patients, helped Epidiolex become the first CBD medication to gain approval earlier this year from both the Food and Drug Administration as wel
12/28/18 - Launch of Generic Lialda Delayed-Release Tablets Expands Mylan's Gastroenterology Product Offering
By a News Reporter-Staff News Editor at Pharma Business Week Global pharmaceutical company Mylan N.V. announced the U.S. launch of Mesalamine Delayed-Release Tablets USP, 1.2 g, a generic version of Shire' s Lialda Delayed-Release Tablets. Mylan Pharmaceuticals received final approval from the U.S. Food and Drug Administration for its Abbrevia
12/28/18 - Mylan Adds First Generic for Canasa Rectal Suppository to Growing Gastroenterology Portfolio
By a News Reporter-Staff News Editor at Pharma Business Week Global pharmaceutical company Mylan N.V. announced the U.S. launch of Mesalamine Rectal Suppository, 1000 mg, the first generic version of Allergan's Canasa Rectal Suppository, 1000 mg. Mylan Pharmaceuticals received final approval from the U.S. Food and Drug Administration for its A
12/28/18 - Orthopedic Devices Market to Receive Overwhelming Hike in Revenues to Reach US$ 58,814.6 Million by 2023
A leading musculoskeletal solutions company, Globus Medical Inc., has announced the launch CREO Fenestrated Screw System that is used for treating patients suffering from advanced stage tumors of the thoracolumbar spine. Medtronic Plc. has declared that the US Food and Drug Administration has offered 510 k clearance of Kyphon HV-R Bone Cement for f
12/28/18 - Studies from S. Niraula et al Further Understanding of Cancer Research (New Cancer Drug Approvals From the Perspective of a Universal Healthcare System: Analyses of the Pan-Canadian Oncology Drug Review Recommendations)
By a News Reporter-Staff News Editor at Cancer Weekly A new study on Oncology- Cancer Research is now available. According to news reporting out of Winnipeg, Canada, by NewsRx editors, research stated, " FDA approvals do not consider cost, but they set the tone for regulatory approvals worldwide, including in countries with universal healthcare w
12/27/18 - Early Investment From Michael J. Fox Foundation Pushes New Parkinson's Treatment to Market
The Michael J. Fox Foundation for Parkinson's Research issued the following news release:. Inbrija from Acorda Therapeutics, Inc. received approval from the U.S. Food and Drug Administration on December 21, 2018, for the treatment of "off" episodes, when Parkinson's symptoms are not well controlled with oral medication. After multiple rounds of ven
12/27/18 - FDA approves Acorda's Inbrija for Parkinson's
Acorda Therapeutics Inc. gained $0.83 to $13.77 on Monday after FDA approved its Inbrija levodopa inhalation powder to treat "off" periods in Parkinson's disease patients receiving carbidopa/levodopa. FDA approved Inbrija ahead of its Jan. 5 PDUFA date, although the drug's review was extended from its original Oct. 5 action date to permit the agenc
12/27/18 - FDA approves new child vaccine to guard against 6 diseases
Sanofi said the pediatric combination vaccine will be available in the United States in 2020. It was developed in a joint-venture between Sanofi and Merck. "Sanofi and MSD are working to maximize production of VAXELIS to allow for a sustainable supply to meet anticipated U.S. demand," Sanofi said in a statement.
12/27/18 - FDA Approves Sanofi And Merck's Pediatric Hexavalent Combination Vaccine Vaxelis
Vaxelis was developed as part of a joint-partnership between Sanofi and Merck& Co. Sanofi and Merck are working to maximize production of VAXELIS to allow for a sustainable supply to meet anticipated U.S. demand. Commercial supply will not be available in the U.S. prior to 2020..
12/27/18 - Haemostatic Agents Market Trends and Forecast | Market Data Forecast 2023
Haemostatic Agents Market By Type. Hemostatic agents have received both U.S. food and drug administration approval and the conformite europeenne approval for external use in trauma settings. *Hospitals* Surgery Centres* Nursing Homes.
12/27/18 - Horizon Pharma Announces FDA Approval to Expand the Age Range for RAVICTI
Horizon Pharma today announced the U.S. Food and Drug Administration has approved a supplemental new drug application to expand the age range for RAVICTI Oral Liquid to include infants younger than two months of age living with a urea cycle disorder. As quoted in the press release:. The FDA approval of RAVICTI for children younger than two mo
12/27/18 - Horizon Pharma plc Announces FDA Approval to Expand the Age Range for RAVICTI (glycerol phenylbutyrate) Oral Liquid to Include Newborns
Horizon Pharma plc today announced the U.S. Food and Drug Administration has approved a supplemental new drug application to expand the age range for RAVICTI Oral Liquid to include infants younger than two months of age living with a urea cycle disorder. RAVICTI is now FDA- approved for use as a nitrogen-binding agent for chronic management of U
12/27/18 - Orthopedic Devices Market to Receive Overwhelming Hike in Revenues to Reach US$ 58,814.6 Million by 2023
A leading musculoskeletal solutions company, Globus Medical Inc., has announced the launch CREO Fenestrated Screw System that is used for treating patients suffering from advanced stage tumors of the thoracolumbar spine. Medtronic Plc. has declared that the US Food and Drug Administration has offered 510 k clearance of Kyphon HV-R Bone Cement for f
12/27/18 - Sanofi: FDA Approves VAXELIS(TM), Sanofi and MSD`s Pediatric Hexavalent Combination Vaccine [Sport360]
-FDA Approves VAXELIS (TM), Sanofi and MSD`s Pediatric Hexavalent Combination Vaccine PARIS and KENILWORTH, N.J.- December 26, 2018- The U.S. Food and Drug Administration has approved VAXELIS (TM) for use in children from 6 weeks through 4 years of age. VAXELIS was developed as part of a joint-partnership between Sanofi and MSD, known as Merck insi
12/27/18 - The FDA Approves Two Orphan Blood Disorder Drugs [Syrian Arab News Agency]
Food and Drug Administration approved two drugs for separate blood disorders, Alexion Pharmaceuticals Ultomiris for the rare blood disorder paroxysmal nocturnal hemoglobinuria, and Stemline Therapeutics Elzonris for blastic plasmacytoid dendritic cell neoplasm. For Alexion, the FDA approval was two months ahead of its February PDUFA date, although.
12/26/18 - Biotech Stock Flies After FDA Approves Parkinson`s Treatment [Daily Independent (Nigeria)]
Acorda Therapeutics` stock surged Monday after the Food and Drug Administration approved its Parkinson`s treatment, Inbrija, several weeks earlier than expected. The Food and Drug approved Inbrija, Acorda`s Parkinson`s treatment, late Friday. The "approval of Inbrija marks a major milestone for both Acorda and the Parkinson`s community, for whom we
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