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 The leading web portal for pharmacy resources, news, education and careers May 26, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - May 26, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 218     Next >>     Go To Page:

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
5/17/17 - Alucent Medical Receives FDA Approval to Begin Clinical Trials of Novel Therapy for Vascular Disease
Alucent Medical, Inc. is a new company formed to develop and market this novel photo-activated drug therapy, and is owned by the research and development arm of Avera Health, an integrated, multi-state health system based in Sioux Falls, S.D.. NVS has the potential to leap-frog current treatments for peripheral vascular disease, said Myles Gr
5/17/17 - Dr. Reddy's Laboratories Announces USFDA Approval for the Launch of Doxorubicin Hydrochloride Liposome Injection in the U.S. Market
HYDERABAD, India& PRINCETON, N.J. Dr. Reddy s Laboratories Ltd. announced today that it has received approval from the U.S. Food and Drug Administration to launch Doxorubicin Hydrochloride Liposome Injection, a therapeutic equivalent generic version of Doxil , for intravenous use, in the United States market. This approval would not have b
5/17/17 - Dr. Reddy's To Launch Generic Version Of Doxil
NEW DELHI- Dr. Reddy's Laboratories Ltd. announced it has received approval from the U.S. FDA to launch Doxorubicin Hydrochloride Liposome Injection, a therapeutic equivalent generic version of Doxil, for intravenous use, in the U.S. market. The Doxil brand and generic had U.S. sales of approximately $196 million MAT for the most recent twelve mont
5/17/17 - European Medical Device Firm BrainCool AB Enters US Market with 510(k) Clearance from FDA for IQoolTM System for Temperature Management
European medical device firm BrainCool AB has received 510 clearance from the US Food and Drug Administration to market its first product in the United States, the IQool TM System, with an indication for use of temperature reduction in adult patients when clinically indicated. Based in Lund, Sweden, Europe, BrainCool AB is a publicly traded medical
5/17/17 - FDA Approves KALYDECO (ivacaftor) for More Than 900 People Ages 2 and Older with Cystic Fibrosis Who Have Certain Residual Function Mutations
Vertex Pharmaceuticals Incorporated today announced that the U.S. Food and Drug Administration has approved KALYDECO for use in people with cystic fibrosis ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator gene. In addition to the mutations added to the label today, Vertex
5/17/17 - FDA Approves LungVision Imaging System for Bronchoscopy
Body Vision Medical has received FDA clearance to market LungVision, a novel imaging system that enables accurate real-time navigation and lesion localization during bronchoscopic procedures.
5/17/17 - FDA: Kalydeco Now Approved to Treat 33 Cystic Fibrosis Mutations
The expanded FDA indication means Kalydeco can be used to treat another 3% of the cystic fibrosis population, impacting approximately 900 patients.
5/17/17 - GLENMARK DRUG GETS USFDA NOD FOR TRIAL
Glenmark Pharmaceuticals Limited has received the approval of US Food and Drug Administration for its investigational new drug application to start Phase I study of GBR 1342, a humanised monoclonal antibody for treatment of multiple myeloma. This is the second investigational new. drug of Glenmark from its immuno-oncology portfolio to enter clinica
5/17/17 - Orfadin capsules approved in the Kingdom of Saudi Arabia for the treatment of hereditary tyrosinemia type 1
Swedish Orphan Biovitrum AB today announces that the Saudi Food and Drug Administration has approved Orfadin capsules in all strengths for the treatment of hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine. The Kingdom of Saudi Arabia is the largest market in the Middle East, and our focus will n
5/17/17 - Oxitone Medical Receives FDA Clearance for Wrist-Sensor Pulse Oximetry Bracelet [T-break Tech (Middle East)]
-Oxitone Medical, an Israeli-based medical device and digital health company developing wearable monitoring solutions to transform delivery of chronic disease home care, has received 510 clearance from the FDA for its wrist-sensor pulse oximetry bracelet Oxitone 1000. The wrist-sensor pulse oximeter Oxitone 1000 measures critical vital signs such a
5/17/17 - Swedish Orphan Biovitrum AB - Orfadin Capsules Approved in the Kingdom of Saudi Arabia for the Treatment of Hereditary Tyrosinemia Type 1
Swedish Orphan Biovitrum AB today announces that the Saudi Food and Drug Administration has approved Orfadin capsules in all strengths for the treatment of hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine. The Kingdom of Saudi Arabia is the largest market in the Middle East, and our focus will n
5/17/17 - XpandOrtho, Inc. Receives FDA 510(k) Clearance for Its Electronic Soft Tissue Balancing Instrument for Total Knee Replacement Surgery
XpandOrtho, Inc., a designer of soft tissue balancing instruments, received FDA clearance on April 25 th of 2017 for their electronic soft tissue balancing instrument for total knee replacement surgery. XpandOrtho has initiated a clinical study at Scripps Clinic, La Jolla, CA and will be conducting a limited release of their product to selected sur
5/16/17 - Abon Received Approval from the US FDA for Clofarabine Injection
Abon Pharmaceuticals, LLC, a specialty pharmaceutical company, today announced that it has received final approval from the FDA for its Abbreviated New Drug Application for Clofarabine Injection, 20 mg/20 mL, Single-use Vial. About Abon Pharmaceuticals, LLC. Abon Pharmaceuticals, LLC is a specialty pharmaceutical company that emphasizes science a
5/16/17 - Alembic Pharma`s cholesterol drug gets US FDA nod [Tehran Times (Iran)]
Alembic Pharmaceuticals has received approval from the US health regulator for Fenofibric Acid Delayed-Release capsules used for lowering high cholesterol and increasing good cholesterol. The company has received US Food and Drug Administration approval for its abbreviated new drug application for its Fenofibric Acid Delayed-Release Capsules, 45...
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