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 The leading web portal for pharmacy resources, news, education and careers May 30, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - May 30, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 196     Next >>     Go To Page:

5/23/17 - Sanofi Says FDA Oks Kevzara To Treat Moderately To Severely Active RA In Adults
PARIS- Sanofi and Regeneron Pharmaceuticals Inc. announced the U.S. Food and Drug Administration approval of Kevzara or sarilumab for the treatment of adult patients with moderately to severely active rheumatoid arthritis or RA who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs or DMARDs, such as
5/22/17 - Actemra Approved for Certain Blood Vessel Inflammation
MONDAY, May 22, 2017 The injected drug Actemra has been approved by the U.S. Food and Drug Administration to treat adults with giant cell arteritis, an inflammation of the blood vessels. In a media release Monday, the FDA said this form of vasculitis mostly involves blood vessels of the head. For that reason, live vaccines should be avoided while
5/22/17 - BIOTRONIK Announces FDA Approval of MultiPole Pacing with ProMRI: 360 Solutions for Patients with Heart Failure
By a News Reporter-Staff News Editor at Biotech Business Week BIOTRONIK announced FDA approval of the company's MultiPole Pacing technology, providing physicians with additional treatment options for heart failure patients who have been non-responsive to cardiac resynchronization therapy. 1 MPP will be available on new BIOTRONIK CRT defibrillator
5/22/17 - Boston Scientific Receives U.S. FDA Approval For Resonate Family Of High-Voltage Devices
By a News Reporter-Staff News Editor at Biotech Business Week Boston Scientific has received U.S. Food and Drug Administration approval for the Resonate? family of implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems. Recent guidance issued by the National Institute for Health and Care Excellence in
5/22/17 - Cornerstone Pharmaceuticals to Present at the BioNJ 7th Annual BioPartnering Conference, May 23, 2017
Sanjeev Luther, Cornerstone s Chief Operating Officer, will present information on the Company s novel Altered Energy Metabolism Directed platform, and will provide an update on Cornerstone s clinical trial development strategy in the wake of the company s recent announcement that it has received approval from the FDA to conduct pivotal
5/22/17 - FDA approves first drug to specifically treat giant cell arteritis
The U.S. Food and Drug Administration today expanded the approved use of subcutaneous Actemra to treat adults with giant cell arteritis. This new indication provides the first FDA- approved therapy, specific to this type of vasculitis. "We expedited the development and review of this application because this drug fulfills a critical need for patie
5/22/17 - FDA Approves Genentech's Actemra (Tocilizumab) for Giant Cell Arteritis
Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration has approved Actemra subcutaneous injection for the treatment of GCA, a chronic and severe autoimmune condition. Actemra is the first therapy approved by the FDA for the treatment of adult patients with GCA. Today s FDA decision means people
5/22/17 - Genentech's Actemra Approved By FDA For Giant Cell Arteritis
SOUTH SAN FRANCISCO- Genentech, a member of Roche Group, said that the U.S. Food and Drug Administration or FDA has approved Actemra, or tocilizumab subcutaneous injection for the treatment of Giant Cell Arteritis or GCA, a chronic and severe autoimmune condition. Actemra is the first therapy approved by the FDA for the treatment of adult patients
5/22/17 - IMFINZITM (durvalumab) Approved for Previously Treated Patients with Advanced Bladder Cancer, Available Immediately at Biologics, Inc.
Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, has been selected by AstraZeneca to be a specialty pharmacy provider in the limited distribution network for IMFINZI TM. Approved by the U.S. Food and Drug Administration on May 1, 2017, IMFINZI is indicated for the treatment of patients with locally advanced or metast
5/22/17 - MT Pharma America Announces FDA Approval of RADICAVA Edaravone, the First New Treatment Option for ALS in More Than 20 Years
By a News Reporter-Staff News Editor at Clinical Trials Week MT Pharma America, Inc. announced the U.S. Food and Drug Administration has granted approval of RADICAVA?, as an intravenous infusion treatment for amyotrophic lateral sclerosis, a rapidly progressive neurodegenerative disease in which the majority of patients die within two to five y
5/22/17 - NxStage Medical Announces FDA Clearance for its New System One Hemodialysis System
By a News Reporter-Staff News Editor at Pharma Business Week NxStage Medical, Inc., a leading medical technology company focused on advancing renal care, announced that its next generation hemodialysis system has received FDA clearance. "Early customer and patient feedback in the UK on our next generation system has been very positive, validatin
5/22/17 - Soterix Medical Announces FDA 510(k) Clearance for IontoDC? System
Soterix Medical Inc., the technology leader in non-invasive electrotherapy devices, announced today it has received a 510 clearance from U.S. Food& Drug Administration for its IontoDC? device intended to use a direct current to introduce ions of soluble salts or other drugs into the body. The FDA cleared IontoDC? device is intended to use direc
5/20/17 - Bladder Cancer Drug Receives FDA Approval Based on Research Led by NYU Langone
These findings were first presented by Dr. Balar last October at the annual meeting of the European Society for Medical Oncology and followed by an updated analysis in February at the Genitourinary Cancers Symposium. Atezolizumab's approval by the FDA last month also was principally based on clinical trial findings by Dr. Balar, who presented those
5/20/17 - New Lenox hospital offers new implant for foot surgery
Anne McCall is always on her feet. As the medical director for radiation oncology at the University of Chicago Medicine Comprehensive Cancer Center at Silver Cross Hospital, it's no surprise she walks all day. The new implant, called the Cartiva Synthetic Cartilage Implant, received FDA approval about a year ago.
5/19/17 - CDC Finalizes Vaccine Recommendation for Adults Traveling to Areas with Cholera
The Centers for Disease Control and Prevention's recommendation for the use of a cholera vaccine in adults traveling to areas with cholera is now final. The final recommendation was published today in CDC' s Morbidity and Mortality Weekly Report. It is approved for use in adults 18 through 64 years old and is the only FDA- approved cholera vaccine
5/19/17 - FDA approves ALS drug Radicava, which could prolong patients` lives [T-break Tech (Middle East)]
For the first time in 22 years, the FDA approved a new ALS treatment called Radicava. Fred Fisher, with the ALS Association Golden West Chapter, said in studies patients experienced a 33 percent slowing in the decline of their symptoms, which is a major development for the devastating disease. The drug`s list price is about $1,000 per infusion, whi
5/19/17 - FDA Expands Approved Use Of Kalydeco To Treat Addl Mutations Of Cystic Fibrosis [Tehran Times (Iran)]
The U.S. Food and Drug Administration today expanded the approved use of Kalydeco or ivacaftor for treating cystic fibrosis. Kalydeco is manufactured for Boston- based Vertex Pharmaceuticals Inc. If the patient`s genotype is unknown, an FDA- cleared cystic fibrosis mutation test should be used to detect the presence of a CFTR mutation followed by..
5/19/17 - Pharma exec says industry must get fair about pricing new drugs [Boston Herald]
We're not getting it right, "said Leonard Schleifer, chief executive of Regeneron, speaking yesterday at the Boston College Chief Executives Club. Regeneron, based in New York, recently received FDA approval for a new drug to treat atopic dermatitis, a form of eczema that can be severe enough to lead to sleeplessness and depression. Both Republican
5/19/17 - Second Drug Receives FDA Approval for Bladder Cancer Based on Research Led by NYU Langone
NEW YORK, May 19, 2017/ PRNewswire-USNewswire/ The U.S. Food and Drug Administration has granted accelerated approval to a second drug in less than a month for first-line treatment for advanced bladder cancer again based on clinical trial findings from the same researcher from NYU Langone's Perlmutter Cancer Center. Pembrolizumab joins the oth
5/19/17 - Sens. Donnelly, Gardner Introduce Bipartisan Bill to Speed Up FDA Approvals for Devices
I'm proud to work with Senator Gardner on this bipartisan legislation to cut through the red tape at the FDA and safely speed up the approval process. " Gardner said, "We need to be providing the FDA with the necessary resources to get lifesaving medical equipment and technologies to market more quickly, while maintaining safety and efficacy.
5/18/17 - Donnelly, Gardner Introduce Bipartisan Bill to Speed up FDA Approvals for Devices
I'm proud to work with Senator Gardner on this bipartisan legislation to cut through the red tape at the FDA and safely speed up the approval process. " Gardner said, "We need to be providing the FDA with the necessary resources to get lifesaving medical equipment and technologies to market more quickly, while maintaining safety and efficacy.
5/18/17 - FDA Approves Merck's KEYTRUDA (pembrolizumab) for Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved two new indications for KEYTRUDA , the company s anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. In the first-line setting, KEYTRUDA is now
5/18/17 - FDA Expands Approved Use of Kalydeco to Treat Additional Mutations of Cystic Fibrosis
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. The U.S. Food and Drug Administration today expanded the approved use of Kalydeco for treating cystic fibrosis. "Many rare cystic fibrosis mutations have such small patient populations that clinical trial studies are not feasible," sa
5/18/17 - FDA Expands Approved Use Of Kalydeco To Treat Addl Mutations Of Cystic Fibrosis
CAMBRIDGE- The U.S. Food and Drug Administration today expanded the approved use of Kalydeco or ivacaftor for treating cystic fibrosis. Kalydeco is manufactured for Boston- based Vertex Pharmaceuticals Inc. If the patient's genotype is unknown, an FDA- cleared cystic fibrosis mutation test should be used to detect the presence of a CFTR mutation fo
5/18/17 - Sangamo Therapeutics Announces Special Regulatory Designations from the FDA for Three Clinical Programs
SB-913 has already received Orphan Drug designation from the FDA. FDA has cleared an Investigational New Drug Application for this program, and a Phase 1/ 2 clinical trial evaluating SB-913 in adults with MPS II is open and screening subjects for enrollment. FDA has cleared an IND for this program, and a Phase 1/ 2 clinical trial evaluating SB-525
Articles(s): 1 - 25 of 196     Next >>     Go To Page:


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