Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers July 23, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - July 23, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 43     Next >>     Go To Page:

7/23/14 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Food and Drug Administration Rapid...
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Food and Drug Administration Rapid Response Surveys. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Generic FDA Rapid Response Surveys" has been approved by the Office of Management and Budg
7/23/14 - FDA Approves Eagle Pharmaceuticals' Ryanodex For The Treatment Of Malignant Hyperthermia
Eagle Pharmaceuticals, Inc. today announced that the U. S. Food and Drug Administration has approved Ryanodex for injectable suspension indicated for the treatment of malignant hyperthermia, along with the appropriate supportive measures. FDA had designated Ryanodex as an Orphan Drug in August 2013. Eagle has been informed by the FDA that it wil
7/23/14 - FDA Approves Eagle Pharmaceuticals Ryanodex for the Treatment of Malignant Hyperthermia
Eagle Pharmaceuticals, Inc. today announced that the U. S. Food and Drug Administration has approved Ryanodex for injectable suspension indicated for the treatment of malignant hyperthermia, along with the appropriate supportive measures. FDA had designated Ryanodex as an Orphan Drug in August 2013. We are very pleased with today s approva
7/23/14 - FDA approves Gilead Sciences drug for 3 cancers
WASHINGTON The Food and Drug Administration on Wednesday approved a new cancer drug from Gilead Sciences Inc. to treat three types of blood cancer. The FDA has approved three other drugs for the disease in the last year: Roche's Gazyva, Janssen Pharmaceutical's Imbruvica and GlaxoSmithKline's Arzerra. The FDA approved Zydelig for leukemia based
7/23/14 - Protein Sciences Receives Approval from FDA for 2014/15 Formulation of Flublok Influenza Vaccine
By a News Reporter-Staff News Editor at Vaccine Weekly Protein Sciences Corporation announced that the FDA has approved the Company's strain change amendment for its seasonal influenza vaccine, Flublok. She added, "We are still accepting orders for the fall and providers are encouraged to order through our distributors FFF Enterprises and ASD Hea
7/23/14 - Review of ADHD drug approvals highlights gaps between pediatric approval process and long-term safety assessment
The study highlights gaps in how the long-term safety of drugs intended for chronic use in children is assessed as part of the FDA approval process. "Instead, we point to the need for an agenda emphasizing improved assessment of rare adverse events and long-term safety through post-marketing trials, comparative effectiveness trials and more active
7/23/14 - U.S. Food and Drug Administration Approves Gilead's Zydelig (idelalisib) for Relapsed Chronic Lymphocytic Leukemia, Follicular Lymphoma and Small Lymphocytic Lymphoma
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved Zydelig 150 mg tablets for the treatment of three B-cell blood cancers. Zydelig is indicated in combination with rituximab for patients with relapsed chronic lymphocytic leukemia for whom rituximab alone would be considered appropriate therapy and as...
7/23/14 - United States : VENITI receives FDA approval for VICI VENOUS STENT SYSTEM [TendersInfo (India)]
U.S. Food and Drug Administration has sanctioned Veniti for one of its devices that looks to treat venous disease. Veniti was approved for its Vici Venous Stent System, which is a stent that is particularly designed for veins. Veniti has utilized funds from its $9.7 million Series B funding round in June 2013 to help formulate the device that is al
7/22/14 - Access Pharmaceuticals Receives 510(K) FDA Marketing Clearance For ProctiGard?
DALLAS and NEW YORK, July 22, 2014/ PRNewswire/ ACCESS PHARMACEUTICALS, INC., a developer of new products for oncology supportive care, announced today that it has received 510 marketing clearance from the U.S. Food and Drug Administration for ProctiGard?, its novel treatment for symptomatic management of rectal mucositis. The Company indicated
7/22/14 - Cytonics Announces FDA Approval of an Investigational New Drug Application for the APIC Cell-Free System
Cytonics Corporation has announced that an Investigational New Drug application for a phase I/II clinical trial of the company's APIC Cell-Free System has been approved by the FDA. The system is indicated for the rapid preparation of concentrated protease inhibitors in plasma, specifically Alpha-2-Macroglobulin, for the treatment of mild to moderat
7/22/14 - Galmed Announces FDA Clearance of IND of Armachol for the Treatment of Fatty Liver Disorders
Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones, announced today that the U.S. Food and Drug Administration, or the FDA, cleared Galmed's Investigational New Drug, or IND, applicatio
7/22/14 - Halozyme Resumes Patient Enrollment And Dosing In PEGPH20 Clinical Program In Pancreatic Cancer
Halozyme Therapeutics, Inc. today announced that it has resumed enrollment and dosing of patients in its ongoing Phase 2 trial evaluating PEGPH20 in patients with pancreatic cancer under the revised clinical protocol agreed to with the FDA in June. PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronid
7/22/14 - Spectral Diagnostics announces shareholder approval of its up to $18.2 million offering
/CNW/- Spectral Diagnostics Inc. today announced that at the special meeting of shareholders of the Corporation held earlier today, Shareholders overwhelmingly approved the terms of the previously announced proposed non-brokered private placement of the Corporation of up to $18.2 million. FDA approval for its lead theranostics product for the treat
7/22/14 - Teleflex Receives FDA Clearance For ARROW-ClarkTM VectorFlow Chronic Hemodialysis Catheter
Teleflex Incorporated, a leading global provider of medical devices for critical care and surgery, has announced it has received FDA 510 clearance to market its ARROW-Clark? VectorFlow? Chronic Hemodialysis Catheter. Timothy Clark, M.D., the VectorFlowTM Catheter features a symmetrical tip design that allows ease of placement and sustained high
7/22/14 - Teleflex Receives FDA Clearance for ARROW-ClarkTM VectorFlow? Chronic Hemodialysis Catheter
Teleflex Incorporated, a leading global provider of medical devices for critical care and surgery, has announced it has received FDA 510 clearance to market its ARROW-Clark? VectorFlow? Chronic Hemodialysis Catheter. Teleflex is a leading global provider of specialty medical devices for a range of procedures in critical care and surgery.
7/21/14 - Biotech Company Receives Application Approval from Chinese Food and Drug Administration
By a News Reporter-Staff News Editor at Biotech Business Week Beike Biotechnology Co., Ltd. has officially been accepted into the approval process for the Chinese Food and Drug Administration for the use of human umbilical cord derived mesenchymal stem cells for clinical translation and treatment of Systemic Lupus Erythamatosus. For three months
7/21/14 - Boston Scientific Receives FDA Approval for REBEL? Platinum Chromium Coronary Stent System
Boston Scientific Corporation has received FDA approval for the REBEL? Platinum Chromium Coronary Stent System, the company's latest generation bare-metal stent for the treatment of coronary artery disease. The REBEL Stent System expands the Boston Scientific family of stents featuring its proprietary platinum chromium alloy and a customized st
7/21/14 - Boston Scientific Reports FDA Approval For REBEL Platinum Stent System
WASHINGTON- Boston Scientific Corp. announced that it has received FDA approval for the REBEL Platinum Chromium Coronary Stent System, the company's latest generation bare-metal stent for the treatment of coronary artery disease. The company announced CE Mark for the Rebel Stent System in February. The REBEL Stent System expands the Boston Scientif
7/21/14 - CASI Pharmaceuticals Receives Approval From CFDA To Conduct Phase II Clinical Trial With ENMD-2076 For Triple-Negative Breast Cancer In China
CASI Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and other diseases, announced today that China's Food and Drug Administration has approved the Company's application to conduct a Phase II clinical trial in triple-negative breast cancer patients in China for its proprietary drug.
7/21/14 - FDA Approves Anacor Pharmaceuticals' KERYDIN? Tavaborole Topical Solution, 5% for the Treatment of Onychomycosis of the Toenails
By a News Reporter-Staff News Editor at Pharma Business Week Anacor Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved the New Drug Application for KERYDIN? topical solution, 5%, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails. "We are pleased to announce t
7/21/14 - Octapharma USA Reports FDA Approval of Octagam 10% [Professional Services Close - Up]
According to a release, the FDA approval marks a significant expansion of Octapharma's U.S. immune globulin therapy portfolio. Octapharma USA is a subsidiary of Octapharma AG, a global human protein products manufacturer, and since 2004 has been marketing Octagam 5 percent to treat Primary Humoral Immunodeficiency. "The FDA approval of Octagam 10
7/21/14 - Par Pharmaceutical Begins Shipment of Fluphenazine Decanoate Injection, USP
By a News Reporter-Staff News Editor at Pharma Business Week Par Pharmaceutical Companies, Inc. announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for fluphenazine decanoate injection, USP 25 mg/mL. Fluphenazine decanoate injection is a long-acting parenteral antipsych
7/21/14 - Perrigo Announces FDA Final Approval For The Store Brand Equivalent To Advil Congestion Relief Tablets, 200 mg/10 mg
By a News Reporter-Staff News Editor at Pharma Business Week Perrigo Company announced that it was the first to receive final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for ibuprofen and phenylephrine hydrochloride tablets, 200 mg/10 mg, the store brand equivalent to Advil Congestion Relief Tablet
7/21/14 - Quantel Medical's Optimis Fusion? Receives FDA 510k Clearance
By a News Reporter-Staff News Editor at Pharma Business Week Quantel Medical announced FDA 510 clearance for its Optimis Fusion? integrated laser platform. The Optimis Fusion system combines advanced selective laser trabeculoplasty photoregeneration therapy and traditional YAG photodisruption treatments to offer ophthalmologists a versatile...
7/21/14 - QUBYX PerfectLum Calibration and QA Software Bundled With Dell U3014 4MP Display Receives FDA 510k Clearance for Diagnostic Viewing
By a News Reporter-Staff News Editor at Pharma Business Week QUBYX, an expert in medical imaging and color calibration fields, has announced that the bundle of PerfectLum DICOM calibration application and Dell UltraSharp U3014 has received the Food& Drug Administration 510 market clearance. Cleared by the FDA, PerfectLum and Dell U3014 bundle wil
Articles(s): 1 - 25 of 43     Next >>     Go To Page:


© 2014 Thomson Reuters. All rights reserved.

Pharmacy News Index
  Drug Delivery Systems
  Drugstores
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry

FEATURED CE LESSON

Lupus: What You Need to Know
This lesson is supported by:
RxSchool
West Virginia Best Practice Prescribing & Drug Diversion Training
This lesson is supported by:
RxSchool

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...


Websites » RxCareerCenter.comRxSchool.comRxProHealth.comPharmacyPages.comNursingJobSource.comNurseZone.comRN.com
Copyright © 2009 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415