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 The leading web portal for pharmacy resources, news, education and careers May 22, 2015
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - May 22, 2015

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 40     Next >>     Go To Page:

5/22/15 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Substances Prohibited From Use in Animal Food or...
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Substances Prohibited From Use in Animal Food or Feed. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled, "Substances Prohibited From Use in Animal Food or Feed" has been approved by the Office of Manag
5/22/15 - ReNeuron Gets Fast Track Designation For Retinitis Pigmentosa Product
LONDON- ReNeuron Group PLC Friday said the US Food and Drug Administration has given a Fast Track designation to the company's human retinal progentiro cell therapy candidate for the treatment of retinitis pigmentosa. The fast track status grant comes after ReNeuron earlier this month said it has received regulatory approval in the US for a phase 1
5/22/15 - U.S. FDA Approves INVEGA TRINZA, First and Only Four-Times-A-Year Treatment for Schizophrenia
Janssen Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration approved under priority review the New Drug Application for the three-month long-acting atypical antipsychotic INVEGA TRINZA. The results of the phase 3 study were published in March by JAMA Psychiatry, a peer-reviewed medical journal published by the American.
5/22/15 - YOLO Curve Solution Treatment Receives FDA Approval
This body contouring treatment, now available at the Fountain of Youth Medical Spa, can safely get clients ready for the upcoming summer season. Interested clients can now experience the YOLO Curve Solution for themselves at the Fountain of Youth Medical Spa in Victoria, Texas. Nhi Le, Fountain of Youth Medical Spa is the premier destination for sl
5/21/15 - FDA OKs Orphan Drug Designation to GlycoMimetics' GMI-1271 for Treatment of Acute Myleogenous Leukemia (AML) [Professional Services Close - Up]
GlycoMimetics reported that the U.S. Food and Drug Administration has granted Orphan Drug designation to GMI-1271, a novel and proprietary E-selectin antagonist in the company's pipeline for treatment of patients with acute myeloid leukemia. "Having the FDA designate GMI-1271 as an orphan drug for the treatment of AML is an important accomplishmen
5/21/15 - Glenmark Pharma receives tentative ANDA approval for Rufinamide Tablets USP [India Infoline News Service]
Shares of Glenmark Pharmaceuticals were trading lower at Rs. 905 on BSE today. The company has been granted tentative approval last week by the US FDA for its Rufinarnide Tablets USP, 200 mg and 400 mg, a therapeutic equivalent of Banzel. According to IMS Health sales data for the 12 month period ending March 2015, the Banzel markey acheived annual
5/21/15 - Research and Markets Adds Report: Regulation on In-Vitro Diagnostics (IVDs) Registration in China [Health & Beauty Close - Up]
Research and Markets has announced the addition of the "Regulation on In-Vitro Diagnostics Registration in China" report to its offerings. In a release, Research and Markets noted that report highlights include:. Regulation on In-Vitro Diagnostics Registration in China has been approved by China Food and Drug Administration on June 27, 2014 and wil
5/21/15 - YOLO Curve Solution Treatment Receives FDA Approval
This body contouring treatment, now available at the Fountain of Youth Medical Spa, can safely get clients ready for the upcoming summer seasonVictoria, TX 05/21/2015 The Yolo Curve Solution an innovative laser treatment designed to promote inch loss around the body has now been cleared by the U.S. Food and Drug Administration. Interest
5/20/15 - Baxter Gets U.S. FDA Approval for 0.9% Sodium Chloride Injection, USP from Sabinanigo, Spain, Facility for the U.S. Market [Health & Beauty Close - Up]
Baxter International reported that the U.S. Food and Drug Administration has approved the company's supplemental drug application to establish its Sabinanigo, Spain, facility as an approved manufacturing site for 0.9 percent Sodium Chloride Injection, USP, for the U.S. market. In a release, the Company noted that the approval includes product prese
5/20/15 - China puts new lupus drug to clinical tests [China Daily: Africa Weekly]
BEIJING Chinese researchers are submitting a new drug for lupus to clinical trials, the Chinese Academy of Sciences said on Wednesday. The new drug SM934, a water-soluble artemisinin derivative, has been approved by the China Food and Drug Administration, the country's pharmaceutical watchdog, CAS said, adding that its Shanghai based researchers
5/20/15 - China puts new lupus drug to clinical tests [China Daily: Hong Kong Edition]
BEIJING Chinese researchers are submitting a new drug for lupus to clinical trials, the Chinese Academy of Sciences said on Wednesday. The new drug SM934, a water-soluble artemisinin derivative, has been approved by the China Food and Drug Administration, the country's pharmaceutical watchdog, CAS said, adding that its Shanghai based researchers
5/20/15 - Cynosure Receives FDA 510(k) Clearance for SculpSure; BlueBird Bio Drug Up For Accelerated OK In U.S., Europe
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 19 2015.{ nfg} Cynosure, Inc., a leader in laser- and light-based aesthetic treatments, announced it has received 510 clearance from the U.S. Food and Drug Administration to market SculpSure?, the world's first hyperthermic laser treatment for no
5/20/15 - Emmes Announces FDA Clearance of New Medical Device
The Emmes Corporation today announced that the U.S. Food and Drug Administration has given marketing clearance for a new device that allows doctors to more accurately assess children's weight without the use of a weight scale. Now with the FDA clearance, the device now can be marketed worldwide. The FDA marketing clearance was based on this study
5/20/15 - Generon Received US FDA Clearance to Initiate Phase IIa Study With F-652, a First-in-Class Biologic, to Treat Patients With Acute GvHD
By a News Reporter-Staff News Editor at Biotech Week Generon Corporation, a leading biotech company in China, announced that it received US FDA clearance of the IND for a Phase IIa study, entitled "Recombinant Human Interleukin-22-IgG2-Fc in Combination with Systemic Corticosteroids for the Treatment of Newly Diagnosed Grade II-IV Lower...
5/20/15 - Lumicell Announces FDA Approval to Launch Feasibility Study
Lumicell, a leader in the field of image-guided cancer surgery, has received Investigational Device Exemption approval from the U.S. Food and Drug Administration to launch a feasibility study for intraoperative imaging of breast cancer during surgery. The study will be conducted at Massachusetts General Hospital. The Principal Investigator for the.
5/20/15 - The Medicines Company Announces FDA Approval of RAPLIXA? Fibrin Sealant, the First and Only Powdered Fibrin Sealant Ready-to-Use for Mild to Moderate...
By a News Reporter-Staff News Editor at Biotech Week The Medicines Company announced the U.S. Food and Drug Administration has approved RAPLIXA? and the RaplixaSpray? device to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques is ineffective or imp
5/20/15 - United States : U.S. FDA Approves INVEGA TRINZA , First and Only Four-Times-A-Year Treatment for Schizophrenia [TendersInfo (India)]
Janssen Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration approved under priority review the New Drug Application for the three-month long-acting atypical antipsychotic INVEGA TRINZA. The results of the phase 3 study were published in March by JAMA Psychiatry, a peer-reviewed medical journal published by the American.
5/19/15 - B. Braun Receives FDA Approval to Offer Broad Spectrum Intravenous Antibiotic-Meropenem, in Its Innovative DUPLEX(R) Container
B. Braun Medical Inc., a leader in infusion therapy and pain management, announced that it received U.S. Food and Drug Administration approval for 500 mg Meropenem for Injection USP and Sodium Chloride Injection USP and 1 g Meropenem for Injection USP and Sodium Chloride Injection USP in B. Braun's DUPLEX Container. "This approval allows us to
5/19/15 - Cynosure Receives FDA 510(k) Clearance for SculpSure
Cynosure, Inc. a leader in laser- and light-based aesthetic treatments, today announced that it has received 510 clearance from the U.S. Food and Drug Administration to market SculpSure?, the world's first hyperthermic laser treatment for non-invasive lipolysis of the flanks. "SculpSure represents an entirely new approach to non-invasive lipolys
5/19/15 - FDA Says OMB Has Approved Information Collection Involving In Vivo Radiopharmaceuticals Used for Diagnosis, Monitoring
WASHINGTON, May 19 The Department of Health& Human Services published the following notice in the Federal Register from the Food& Drug Administration:. A Notice by the Food and Drug Administration on 05/19/2015. FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRASta
5/19/15 - Roche Gets FDA Approval for cobas KRAS Mutation Test [Professional Services Close - Up]
Roche reported that the U.S. Food and Drug Administration recently approved the cobas KRAS Mutation Test for diagnostic use. With this approval, Roche now offers the most comprehensive companion diagnostic FDA approved portfolio for oncology in the U.S., including tests for BRAF, EGFR and KRAS mutations. " Roche specializes in research-focused heal
5/19/15 - U.S. FDA Approves INVEGA TRINZA?, First and Only Four-Times-A-Year Treatment for Schizophrenia
Janssen Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration approved under priority review the New Drug Application for the three-month long-acting atypical antipsychotic INVEGA TRINZA?. The results of the phase 3 study were published in March by JAMA Psychiatry, a peer-reviewed medical journal published by the Americ
5/18/15 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Formula Requirements
SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled, "Infant Formula Requirements" has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995.. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd.,
5/18/15 - Baxter Receives U.S. FDA Approval for 0.9% Sodium Chloride Injection, USP from Sabinanigo, Spain, Facility for the U.S. Market
DEERFIELD, Ill.- Baxter International Inc. announced today that the U.S. Food and Drug Administration has approved the company's supplemental drug application to establish its Sabinanigo, Spain, facility as an approved manufacturing site for 0.9% Sodium Chloride Injection, USP, for the U.S. market. The approval includes product presentations in 250
5/18/15 - FDA Announces OMB Approval on Information Collection for Infant Formula Requirements
WASHINGTON, May 18 The Department of Health& Human Services published the following notice in the Federal Register from the Food& Drug Administration:. A Notice by the Food and Drug Administration on 05/18/2015. FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRASta
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