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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)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 212     Next >>     Go To Page:

9/12/17 - Implanet Announces Clearance of the New JAZZ? Passer
FDA clearance granted in the US for the new system devoted to posterior fixation in spine surgery, compatible with all JAZZ? Platform implants. IMPLANET, a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has received FDA clearance to market the new JAZZ? Passer. Implanet addresses an ever-
9/12/17 - Sandoz proposed biosimilar rituximab accepted for review by the FDA
HOLZKIRCHEN, Germany, Sept. 12, 2017/ PRNewswire/ Sandoz, a Novartis Division, and the pioneer and global leader in biosimilars, announced today that the US Food and Drug Administration has accepted its Biologics License Application under the 351 pathway for a proposed biosimilar to the reference medicine, Rituxan ?. "The cost of treating ca
9/11/17 - ACTELION RECEIVES FDA APPROVAL OF TRACLEER FOR USE IN PEDIATRIC PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION
Release date- 08092017- SOUTH SAN FRANCISCO, Calif- Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson& Johnson, announced today that the U.S. Food and Drug Administration has approved a new 32 mg tablet for oral suspension for TRACLEER for use in pediatric patients aged three years and older with idiopathic o
9/11/17 - C. R. Bard Receives FDA Premarket Approval of the LUTONIX 035 Drug Coated Balloon as the First and Only DCB for the Treatment of Patients with...
By a News Reporter-Staff News Editor at Clinical Trials Week C. R. Bard, Inc. announced the LUTONIX 035 Drug Coated Balloon PTA Catheter has been granted premarket approval by the U.S. Food and Drug Administration for a new indication and is now available for sale in the United States. With this approval, the LUTONIX 035 DCB Catheter become
9/11/17 - Global Health Solutions Announces FDA Clearance of Novel, Non-Steroidal Topical Ointment for Atopic Dermatitis
By a News Reporter-Staff News Editor at Pharma Business Week Global Health Solutions, a Georgia based biotechnology company engaged in the development of novel, topical therapeutic agents for chronic wounds and dermatologic conditions, has announced FDA clearance of AtopX? Emulsion, indicated for the management of atopic, irritant, and radiatio
9/11/17 - Multimedia Assets Now Available: Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah tisagenlecleucel, CTL019, for children...
Multimedia Assets Now Available: Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah tisagenlecleucel, CTL019, for children and young adults with B-cell ALL that is refractory or has relapsed at least twice. By a News Reporter-Staff News Editor at Cancer Vaccine Week Novartis announced that the US Food and Drug Administrat
9/11/17 - UChicago Medicine working to offer breakthrough CAR T-cell gene therapy approved by FDA
By a News Reporter-Staff News Editor at Cancer Gene Therapy Week The University of Chicago Medicine is one of a limited number of U.S. sites working to offer a breakthrough gene therapy for pediatric acute lymphoblastic leukemia, which was just approved by the U.S. Food and Drug Administration. "CAR T-cell therapy has revolutionized the treatmen
9/11/17 - Victoza liraglutide is approved in the US as the only type 2 diabetes treatment indicated to reduce the risk of three major adverse cardiovascular...
By a News Reporter-Staff News Editor at Diabetes Week The U.S. Food and Drug Administration has approved a new indication for Victoza to reduce the risk of major adverse cardiovascular events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease.1. "Physicians have come to rely on Victoza as an effec
9/9/17 - FDA approves first cell-based gene therapy for use in the United States [Tehran Times (Iran)]
The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. The FDA approved Kymriah for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia.
9/8/17 - Actelion receives FDA approval for 32mg Tracleer to treat paediatric PAH patients [Arab Finance (Egypt)]
Actelion Pharmaceuticals US, a Janssen Pharmaceutical Company of Johnson& Johnson, has received US Food and Drug Administration approval for Tracleer to be used in paediatric patients with idiopathic or congenital pulmonary arterial hypertension. The FDA has granted approval for a new 32 mg tablet for oral suspension for Tracleer to treat PAH patie
9/8/17 - MyndMove FES Therapy Receives 510(k) Clearance from FDA
MyndTec announces it has received FDA 510(k) clearance to market MyndMove, a functional electrical stimulation (FES)-based therapy to help those with upper limb paralysis improve voluntary control of their arms and hands, in the US.
9/8/17 - Perrigo Announces Final FDA Approval And Settlement For The Store Brand OTC Equivalent Of Nexium 24HR Capsules
By a News Reporter-Staff News Editor at Drug Week Perrigo Company plc announced that it has received final approval from the U.S. Food& Drug Administration for the store brand OTC equivalent of Nexium 24 HR capsules. The company also announced that it has reached a settlement of patent litigation with AstraZeneca allowing for the store brand O
9/8/17 - SKINNEY Medspa in New York City Now Offers New FDA Cleared CoolSculpting That Freezes Away Upper Arm Fat
SKINNEY Medspa, a luxury medical spa with location in New York City has announced that they are now offering the new FDA cleared Coolsculpting procedure that freezes away upper arm fat. ZELTIQ Aesthetics, Inc., manufactures of the CoolSculpting System, announced the recent FDA clearance of CoolSculpting's non-invasive treatment for reducing u
9/8/17 - WONTECH to hold PICOCARE workshop at EADV Congress 2017 in Geneva, Switzerland
A leading Korean laser and energy-based medical device company, WONTECH, will attend the 26 th EADV Congress that takes place in Geneva, Switzerland from September 13 to 17. PICOCARE received U.S. FDA approval last June, the first in the industry from an Asian company. During the congress, a WONTECH clinical specialist will hold a PICOCARE worksh
9/7/17 - Actelion Receives FDA Approval of Tracleer (bosentan) for Use in Pediatric Patients With Pulmonary Arterial Hypertension
Johnson and Johnson issued the following news release:. Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson& Johnson, announced today that the U.S. Food and Drug Administration has approved a new 32 mg tablet for oral suspension for TRACLEER (R) for use in pediatric patients aged three years and older with idio
9/7/17 - ACTELION RECEIVES FDA APPROVAL OF TRACLEER FOR USE IN PEDIATRIC PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION
Release date- 06092017- SOUTH SAN FRANCISCO, Calif.- Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson& Johnson, announced today that the U.S. Food and Drug Administration has approved a new 32 mg tablet for oral suspension for TRACLEER for use in pediatric patients aged three years and older with idiopathic
9/7/17 - Avera Part of Groundbreaking Clinical Trial for Advanced Lung Cancer Using Innovative Tri-Drug Approach
The clinical trial is part of the Worldwide Innovative Networking Consortium and recently received U.S. Food and Drug Administration approval to move ahead with clinical trials. It is the latest in several planned trials to be offered at Avera, which will improve patient access to cutting edge clinical research in the Sioux Falls region.
9/7/17 - BioPhotas Inc. Clears Additional FDA and Intellectual Property Hurdles
BioPhotas, Inc. announced today 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 peri-orbital wrinkles, acne, muscle and joint pain, musc
9/7/17 - eNeura, Inc. Receives FDA Clearance for Use of SpringTMS for Migraine Prevention
With this FDA clearance the SpringTMS is the only product in the United States indicated both for the acute and prophylactic treatment of migraine headache. "The addition of migraine prevention to our SpringTMS label is a breakthrough for migraine headache patients in the U.S. SpringTMS provides the first-ever migraine product indicated for both a
9/7/17 - Janssen Pharmaceutical Companies - Idylla Respiratory Panel receives 510 clearance by US FDA
Release date- 06092017- Beerse, Belgium- Janssen Diagnostics, LLC, one of the Janssen Pharmaceutical Companies of Johnson& Johnson, today announced that the United States Food and Drug Administration has granted 510 clearance for the Idylla Respiratory Panel, a diagnostic test developed by Janssen Diagnostics scientists in partnership with Biocarti
9/7/17 - Sarepta soars on positive results from early-stage DMD clinical trial [Tehran Times (Iran)]
Shares in Sarepta Therapeutics Inc surged in pre-market trade on Wednesday after the drug developer reported successful results from an early stage trial of its Duchenne muscular dystrophy treatment. Sarepta already has a drug that received accelerated approval from the FDA last year and is approved for treatment in patients who have a confirmed...
9/7/17 - Siemens Healthineers Receives FDA Clearance for TrueFusion Structural Heart Disease Feature
Siemens Healthineers issued the following news release:. The Food and Drug Administration has cleared TrueFusion, a new cardiovascular application from Siemens Healthineers that integrates ultrasound and angiography images to guide cardiac teams when administering treatment for structural heart disease. Available on the new Release 5.0 of the ACUSO
9/7/17 - Sobi receives approval from the FDA for once daily dosing frequency of Orfadin for the treatment of HT 1
Release date- 06092017- Swedish Orphan Biovitrum AB has received approval from the U.S. Food and Drug Administration for a reduced dosing frequency for Orfadin from twice daily to once daily in patients 5 years of age and older. A once-daily dosing option was also approved by the European Commission in the beginning of 2017.. 'We are very happy to
9/6/17 - AbbVie Submits New Drug Application to U.S. FDA for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain
AbbVie, a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc., announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for elagolix, an investigational, orally administered gonadotropin-releasing hormone antagonist, being evaluated for the managem
9/6/17 - Actelion Receives FDA Approval Of TRACLEER (bosentan) For Use In Pediatric Patients With Pulmonary Arterial Hypertension
Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson& Johnson, announced today that the U.S. Food and Drug Administration has approved a new 32 mg tablet for oral suspension for TRACLEER for use in pediatric patients aged three years and older with idiopathic or congenital pulmonary arterial hypertension, t
Articles(s): 1 - 25 of 212     Next >>     Go To Page:


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