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 The leading web portal for pharmacy resources, news, education and careers May 25, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - May 25, 2016

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 35     Next >>     Go To Page:

5/25/16 - IDegLira receives positive 16-0 vote in favour of approval from FDA Advisory Committee [National News Agency (Lebanon)]
Based on the data contained in the New Drug Application for IDegLira, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to establish the efficacy and safety profile of IDegLira for the treatment of adults with type 2 diabetes. We look forward to working with the FDA as they complete their review of IDegL
5/24/16 - Avantis Medical Systems Receives 510(k) Clearance from FDA for Resposable Third Eye Panoramic Device for Colonoscopy [tayyar.org (Lebanon)]
-Avantis Medical Systems, Inc., a technology leader in developing novel digital imaging devices, today announced that it has received 510 clearance from the U.S. Food& Drug Administration for its Third Eye Panoramic device for use as a resposable product for colonoscopies. Previously cleared as a disposable device, this latest clearance now allows
5/24/16 - IDegLira receives positive 16-0 vote in favour of approval from FDA Advisory Committee
Based on the data contained in the New Drug Application for IDegLira, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to establish the efficacy and safety profile of IDegLira for the treatment of adults with type 2 diabetes. The NDA for IDegLira was submitted to the FDA in September 2015 under the FDA'
5/24/16 - IDegLira receives unanimous 16-0 vote in favor of approval from FDA Advisory Committee
Based on the data contained in the New Drug Application for IDegLira, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to establish the efficacy and safety profile of IDegLira for the treatment of adults with type 2 diabetes. The NDA for IDegLira was submitted to the FDA in September 2015 under the FDA'
5/24/16 - Perimeter Medical Imaging Receives FDA Clearance for OTISTM Optical Tissue Imaging System
Perimeter Medical Imaging, Inc., an innovative medical imaging company whose mission is to revolutionize tissue removal surgery for surgeons and patients, today announced receipt of U.S. Food and Drug Administration 510 clearance for its OTIS TM 1.0 Optical Coherence Tomography System. Ted James, Medical Director of Skin& Soft Tissue Surgical Oncol
5/24/16 - Regen BioPharma, Inc. Files Application to Trade Publicly on OTCQB
Regen BioPharma, Inc.,, and has applied to OTC Markets Group Inc. to uplist Regen's Common and Series A Preferred shares to the OTCQB Venture Marketplace. Regen BioPharma Inc. has cleared an investigational new drug application with the U. S. Food and Drug Administration and is preparing to enter Clinical Phase I in the treatment for aplastic anemi
5/24/16 - SELLAS? Life Sciences Announces Upcoming Presentation of Phase 2 Clinical Results for WT1 Cancer Vaccine at the 2016 ASCO Annual Meeting
ZUG, Switzerland and NEW YORK, May 24, 2016/ PRNewswire/ SELLAS? Life Sciences Group, a development-stage biopharmaceutical company with its main focus on developing innovative products to treat cancer, today announced that results from a Phase 2 trial of the Company's WT1 cancer vaccine, galinpepimut-S, in patients with acute myeloid leukemia
5/24/16 - Seqirus Gets FDA Approval For Flucelvax Quadrivalent For 4 Yrs Of Age And Older
BASEL- Seqirus, part of CSL Limited, said that the US Food and Drug Administration has approved Flucelvax Quadrivalent or Influenza Vaccine, the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older.FLUCELVAX QUADRIVALENT helps protect against the two influenza A viruses and two B virus
5/24/16 - Seqirus receives FDA approval for FLUCELVAX QUADRIVALENT? (Influenza Vaccine) for people four years of age and older
Seqirus announced today that the US Food and Drug Administration has approved FLUCELVAX QUADRIVALENT?, the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older. 1,2 FLUCELVAX QUADRIVALENT helps protect against the two influenza A viruses and two B viruses recommended by the World H
5/23/16 - Avantis Medical Systems Receives 510(k) Clearance from FDA for Resposable Third Eye Panoramic? Device for Colonoscopy
Avantis Medical Systems, Inc., a technology leader in developing novel digital imaging devices, today announced that it has received 510 clearance from the U.S. Food& Drug Administration for its Third Eye Panoramic? device for use as a resposable product for colonoscopies. Previously cleared as a disposable device, this latest clearance now
5/23/16 - CASI Pharmaceuticals Receives Approval From CFDA To Conduct Phase 2 Clinical Trial With ENMD-2076 For Fibrolamellar Carcinoma FLC
By a News Reporter-Staff News Editor at Clinical Trials Week CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announces that China's Food and Drug Administration has approved the Company's application to conduct a Phase 2 clinical trial in fibrolamellar..
5/23/16 - Diadexus, Inc. and Sonic Healthcare USA Sign National Agreement for PLAC(R) Activity Test
Diadexus, Inc., a diagnostics company developing and commercializing products that aid in assessing the prognosis of cardiac disease, today announced it has signed an agreement with Sonic Healthcare USA to launch the company's PLAC Activity Test into Sonic's national network of laboratories. The PLAC Test for Lp-PLA2 Activity is the only FDA-
5/23/16 - Infusion Pump Provides EMR Integration, Improved Security
Hospira has received FDA clearance for the LifeCare PCA 7.0 infusion system, the first PCA infusion pump to enable integration with the electronic medical record. The system also offers enhanced cybersecurity protections like hospital-configured device passwords to prevent unauthorized access.
5/23/16 - Wet Original Personal Lubricant Receives FDA 510k Medical Device Clearance from Food and Drug Administration
"It's a good thing the FDA has been cracking down on the lubricant industry, requiring every lubricant on the market to submit a 510 application to the FDA in order to legally be marketed. Consumers need to understand that Personal Lubricants are applied to mucous membranes and are very easily absorbed into the body, so it's important to make sure
5/22/16 - Eisai Announces FDA Approval of FYCOMPA perampanel Oral Suspension for Adjunctive Therapy in the Treatment of Partial-Onset Seizures and Primary...
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Eisai Inc. announced that the U.S. Food and Drug Administration has approved FYCOMPA CIII Oral Suspension as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in patien
5/20/16 - FDA Grants Profound Medical Corp. IDE Approval for TULSA-PRO [Khaleej Times (United Arab Emirates)]
-Profound Medical Corp., an emerging medical device company focused on prostate care, today announced that it has been granted Investigational Device Exemption approval from the U.S. Food and Drug Administration, for a multicenter Pivotal Clinical Trial. This study is expected to set the path to 510 k regulatory approval and we look forward to work
5/20/16 - Nordic Nanovector First Quarter 2016 Results: Strong Progress on All Priorities and Execution on Track [Global Data Point]
Nordic Nanovector reports steady operational progress on Betalutin ' s clinical development plan in Follicular Lymphoma, with recruitment of both sites and patients proceeding according to schedule. Having received clearance of the Investigational New Drug Application from the FDA and acceptance of the protocol design from EU Authorities, Nordic.
5/20/16 - Switzerland : FDA grants Roches cancer immunotherapy Tecentriq (atezolizumab) accelerated approval for people with a specific type of advanced... [TendersInfo (India)]
Switzerland: FDA grants Roches cancer immunotherapy Tecentriq accelerated approval for people with a specific type of advanced bladder cancer. Roche today announced that the U.S. Food and Drug Administration granted accelerated approval to Tecentriq for the treatment of people with locally advanced or metastatic urothelial carcinoma who have diseas
5/20/16 - Techmedic International B.V. Receives FDA Clearance for Its Dyna-Vision Telemonitoring System
Broek op Langedijk, Netherlands, May 20, 2016 Techmedic International B.V., a leading developer and manufacturer of remote diagnostic monitoring solutions in the digital health market, is pleased to announce that it has received FDA clearance for its Dyna-Vision Telemonitoring System. The wireless, patch-based ECG and vital signs monitoring sys
5/20/16 - United States : FDA approves Aurobindo Pharma to market anesthesia drug bupivacaine hydrochloride in US and more health updates [TendersInfo (India)]
Piramal Enterprises Ltd said a consolidated net profit of Rs.180.24 crore for the March quarter. Aurobindo Pharma Ltd said it has got last sanction from the US Food and Drug Administration to sell anesthesia drug bupivacaine hydrochloride in the US. Pfizer Inc. will purchase Anacor Pharmaceuticals Inc. in a pact worth at $5.2 billion, total of hard
5/19/16 - Boston Scientific Gets FDA Approval For Precision Montage MRI SCS System
WASHINGTON- Boston Scientific Corp. said it has launched the Precision Montage MRI Spinal Cord Stimulator or SCS System after receiving approval from the U.S. Food and Drug Administration or FDA. Boston Scientific is introducing the system at the 8th World Congress of the World Institute of Pain in New York City on May 20 to 23, 2016. The company n
5/19/16 - Boston Scientific Receives U.S. FDA Approval for Precision Montage? MRI Spinal Cord Stimulator System
Boston Scientific Corporation today announced the launch of the Precision Montage? MRI Spinal Cord Stimulator System after receiving approval from the U.S. Food and Drug Administration. Boston Scientific is introducing the system at the 8th World Congress of the World Institute of Pain in New York City on May 20-23, 2016. The new SCS system als
5/19/16 - FDA Approves New Drug to Treat Bladder Cancer
THURSDAY, May 19, 2016 A new drug to treat bladder cancer was approved by the U.S. Food and Drug Administration on Wednesday. Richard Pazdur, director of the office of hematology and oncology products in the FDA's Center for Drug Evaluation and Research, said in an agency news release. The FDA approved Tecentriq for treatment of patients with loc
5/19/16 - FDA Grants Profound Medical Corp. IDE Approval for TULSA-PRO?
Profound Medical Corp., an emerging medical device company focused on prostate care, today announced that it has been granted Investigational Device Exemption approval from the U.S. Food and Drug Administration, for a multicenter Pivotal Clinical Trial. David Penson, Professor and Chair, Department of Urologic Surgery, and Dr. Sandeep Arora, Assi
5/19/16 - Immunotherapy drug for bladder cancer approved by FDA
The U.S. Food and Drug Administration approved an immunotherapy drug for bladder cancer, making available the fourth drug on the market that shrinks or kills tumors by turning the immune system against cancer cells. Tecentriq gained FDA approval for the most common type of bladder cancer, urothelial carcinoma, after being given a breakthrough thera
Articles(s): 1 - 25 of 35     Next >>     Go To Page:


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