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 The leading web portal for pharmacy resources, news, education and careers September 20, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - September 20, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 210     Next >>     Go To Page:

9/13/17 - Addivant(TM) Receives Formal Approval From the FDA for Food Contact Use of Its Nonylphenol-Free Antioxidant Weston 705 in Styrene Block Polymers
DANBURY, Conn., Sept. 13, 2017 Addivant (TM), the world leading supplier of liquid phosphite antioxidants for plastics, announced today that its nonylphenol-free stabilizer, WESTON 705, has received formal approval from the US Food and Drug Administration for food contact use in styrene block polymers. This expands the food contact use of WEST
9/13/17 - Addivant? Receives Formal Approval From the FDA for Food Contact Use of Its Nonylphenol-Free Antioxidant Weston 705 in Styrene Block Polymers
DANBURY, Conn., 2017-09-13 14:42 CEST Addivant?, the world leading supplier of liquid phosphite antioxidants for plastics, announced today that its nonylphenol-free stabilizer, WESTON 705, has received formal approval from the US Food and Drug Administration for food contact use in styrene block polymers.. This expands the food contact use o
9/13/17 - Agilent Obtains U.S. FDA Approval for GenetiSure Dx Postnatal Assay
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 identify a definitive
9/13/17 - FDA Clears Siemens Cardiovascular App for Structural Heart Disease
The FDA has cleared TrueFusion, a new cardiovascular application from Malvern, Pa.-based Siemens Healthineers that integrates ultrasound and angiography images to guide cardiac teams when administering treatment for structural heart disease. The app is available on the new release 5.0 of the ACUSON SC2000 cardiovascular ultrasound system.
9/13/17 - FDA Clears Two New CPAP Masks from 3B Medical
3B Medical has received FDA 510(k) clearance for two new CPAP masks, the Viva Nasal Mask and the Numa Full Face Mask, according to a company announcement.
9/13/17 - GSK's Shingrix containing Agenus' QS-21 Stimulon adjuvant receives Unanimous FDA Advisory Committee recommendation for approval
Agenus Inc., an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that GlaxoSmithKline's shingles vaccine candidate, Shingrix, containing Agenus' proprietary immune adjuvant, QS-21 Stimulon , was unanimously recommended for approval by the U.S. Food and Drug Administration's Vaccines an
9/13/17 - Johnson & Johnson Stops Hepatitis C Drug Development Program [Algeria Press Service]
According to Janssen, the decision was made in light of the increasing availability of a number of highly effective therapies addressing the medical need in hepatitis C. In July of this year, Gilead received FDA approval for Vosevi, its fourth drug developed to treat hepatitis C. Specifically, the drugmaker will halt development on JNJ-4178, an inv
9/13/17 - U.S. FDA Accepts for Review Astellas' Supplemental New Drug Application for mirabegron for Use in Combination with solifenacin succinate 5 mg for the Treatment of Overactive Bladder
Astellas Pharma Inc. announced today that the U.S. Food and Drug Administration has accepted for review a supplemental New Drug Application that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
9/12/17 - Douglas Medical Products Inc. Receives FDA 510(k) Clearance for the TUBETECH IV Administration Set
Douglas Medical Products, Inc., a growing medical device company focused on contract manufacturing of IV Administration/ Extension Sets and Enteral Sets, announced today that it has received 510 clearance for TUBETECH IV Administration Sets from the U.S. Food and Drug Administration. This FDA clearance allows Douglas Medical Products to begin
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
9/12/17 - T.R.U.E. Test Ready-To-Use Patch Test Receives FDA Approval For Pediatric Use
SmartPractice has received FDA approval for T.R.U. E. TEST ready-to-use patch test panels for pediatric patients as young as 6 years of age. E. TEST is the only FDA- approved product for diagnosing allergic contact dermatitis, a persistent skin rash caused by exposure to substances to which a patient is allergic.
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
Articles(s): 1 - 25 of 210     Next >>     Go To Page:


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