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 The leading web portal for pharmacy resources, news, education and careers October 15, 2018
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - October 15, 2018

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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10/15/18 - CIVCO Radiotherapy Announces FDA 510k Clearance and CE Mark of their Solstice SRS Immobilization System
CIVCO Radiotherapy, the leading global provider of high quality, innovative, patient-centric radiotherapy solutions, is delighted to announce FDA 510 k clearance and EU CE mark for their Solstice? SRS Immobilization System. The product will be available for shipment following its display at the American Society for Radiation Oncology Meeting ta
10/15/18 - Dr Reddy's to market aspirin, anti-coagulant drug in US [New Indian Express (India)]
HYDERABAD: Dr Reddys Laboratories Ltd Monday announced it has received the approval of the US Food and Drug Administration to market aspirin and dipyridamole capsules in the USA. Aggrenox is a registered trademark of pharmaceutical major Boehringer Ingelheim, the release said. The Aggrenox brand and the generic drug registered sales of approximatel
10/15/18 - Dr. Reddy's Laboratories Receives Approval for Aspirin and Extended-Release Dipyridamole Capsules in the U.S. Market
HYDERABAD, India& PRINCETON, N.J. Dr. Reddy s Laboratories Ltd today announced receipt of approval for Aspirin and Extended-Release Dipyridamole Capsules, a therapeutic equivalent generic version of Aggrenox Capsules in the United States market from the U.S. Food and Drug Administration. The Aggrenox brand and generic had U.S. sales of appro
10/15/18 - Dr. Reddy's: Aspirin And Extended-Release Dipyridamole Capsules Approved In US
NEW DELHI- Dr. Reddy's Laboratories Ltd. announced Monday the receipt of approval for Aspirin and Extended-Release Dipyridamole Capsules, a therapeutic equivalent generic version of Aggrenox Capsules in the United States market from the U.S. Food and Drug Administration. The company said it is working towards launching the product. Aggrenox brand,
10/15/18 - EyePoint Pharmaceuticals Receives FDA Approval of YUTIQ? (fluocinolone acetonide intravitreal implant) 0.18 mg
EyePoint Pharmaceuticals, Inc., a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, announced today that the U. S. Food and Drug Administration has approved YUTIQ? for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The approval of YUTIQ
10/15/18 - EyePoint shares sag despite FDA nod
EyePoint Pharmaceuticals, Inc. slumped Monday morning, after the company reported that it has received the Food and Drug Administration approval for YUTIQ 0.18 mg. CEO Nancy Lurker said, "The approval of YUTIQ by the FDA is a significant milestone achieved by the Company and marks the second approved ophthalmic product in our pipeline that we plan
10/15/18 - Qiagen Receives FDA Approval to Expand Use of EGFR Test in Lung Cancer
FDA approval allows use of the Therascreen EGFR RGQ PCR kit as a companion diagnostic for Pfizer's Vizimpro (dacomitinib) in patients with non-small cell lung cancer.
10/15/18 - Reflexion Health and Duke Clinical Research Institute Announce Results of the First Randomized Controlled Trial Demonstrating Virtual Physical Therapy Outperforms Traditional Approach
Reflexion Health, the virtual rehabilitation therapy company, in conjunction with the Duke Clinical Research Institute, today announced positive results from a randomized controlled clinical trial, "Virtual Exercise Rehabilitation In-home Therapy: A Research Study." We are pleased with the results of the study which show that Reflexion Health's V
10/13/18 - FDA Approves Arikayce to Treat Certain Patients With Rare Lung Disease [T-break Tech (Middle East)]
Arikayce, a new drug for treating lung disease caused by a group of bacteria, Mycobacterium avium complex, was recently approved by the FDA for treating a limited population of patients with the disease who do not respond to conventional treatment. That means utilizing novel tools intended to streamline development and encourage investment into the
10/13/18 - FDA approves novel molecular-based assay to help determine blood compatibility [Syrian Arab News Agency]
The U.S. Food and Drug Administration today approved ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient non-ABO red blood cell types. "The approval of the ID CORE XT Test can streamline blood compatibility testing and provides an a
10/13/18 - FDA sets record for number of generic drug approvals again [Sudan Tribune]
The FDA has approved and tentatively approved more generic drugs in FY 2018 than any other year prior, the agency announced Thursday. When I started as FDA commissioner, I made clear that one of my top priorities would be ensuring the agency does all it can to help ensure American patients have access to affordable, quality medicines that meet thei
10/12/18 - Celltrions Rituxan biosimilar wins backing from US FDA advisory committee [Sport360]
South Korean biopharma company Celltrion is on track toward launching its Rituxan biosimilar in the US market, as the drug has obtained the endorsement of the US Food and Drug Administrations drug advisory committee. Celltrion and its marketing partner Teva Pharmaceutical Industries said Thursday that the US FDAs Oncologic Drugs Advisory Committee.
10/12/18 - FDA Approves Grifols ID CORE XT Test For Molecular Red Blood Cell Typing
Grifols, a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, received approval from the U.S. Food& Drug Administration for its ID CORE XT molecular diagnostic test for in-vitro diagnostic use in the United States. The blood group genotyping kit has been CE-IVD marked in Europe
10/12/18 - Shire holds formal ribbon-cutting ceremony
SOCIAL CIRCLE- Shire officials confirmed the company's ongoing commitment to its employees, state and local communities, and to the patients who rely on its plasma-based therapies, at a formal ribbon-cutting ceremony Thursday morning. The biopharma giant, which began construction of its facility in Stanton Springs six years ago, received FDA approv
10/12/18 - SpineEX Announces FDA Clearance of Sagittae Lateral Lumbar Interbody Fusion Devices [Sudan Tribune]
SpineEX, Inc., a medical device company that aims to provide innovative and minimally invasive implants, high-value disposables and instrumentation for spinal fusion surgeries, announced today it has received 510 clearance from the U.S. Food and Drug Administration for its Sagittae lateral lumbar interbody fusion device. The LLIF procedure uses...
10/12/18 - U.S. FDA Approves XARELTO to Reduce the Risk of Major Cardiovascular Events in Patients With Chronic Coronary Artery Disease or Peripheral Artery Disease
Janssen Pharmaceutical Companies, a subsidiary of Johnson and Johnson, issued the following news release:. The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration has approved XARELTO (R) to reduce the risk of major cardiovascular events, such as CV death, myocardial infarction and stroke,
10/11/18 - 26 Stocks Moving In Thursday's Pre-Market Session
Gainers Compugen Ltd. rose 21.8 percent to $3.96 in pre-market trading after the announcement of a $12 million investment and collaboration with Bristol-Myers Squibb. TransEnterix, Inc. shares rose 12.2 percent to $5.06 in pre-market trading after the company received FDA 510 clearance for its 3 mm diameter surgical instruments for minimally invasi
10/11/18 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Agency: " Food and Drug Administration, HHS." SUMMARY: The Food and Drug Administration is publishing a list of information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995.. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three
10/11/18 - FDA approves record number of generics in FY18
FDA approved 971 generic drugs during FY18, the most the agency has ever approved in a fiscal year. The figure rose from 937 during FY17, and 835 in FY16. The agency issued 781 final approvals and 190 tentative approvals during FY18, which ended Sept. 30.
10/11/18 - FDA Approves Stiolto Respimat Supplemental New Drug Application (sNDA) to Add Data on COPD Exacerbation Reduction
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration approved new labeling for Stiolto Respimat Inhalation Spray that includes data showing a meaningful reduction in COPD exacerbations driven by tiotropium, which is the active ingredient in Spiriva Respimat Inhalation Spray. Stiolto Respimat is a combination medicine th
10/11/18 - K2M Receives FDA Clearance Including Surgical Guidance that Enhances MESA Platform
K2M a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, announced at the Scoliosis Research Society 53rd Annual Meeting& Course, in Bologna, Italy a U.S. Food and Drug Administration 510 clearance that also provides for the Dual Differential Correction Philosophy& Technique.
10/11/18 - K2M Receives FDA Clearance Including Surgical Guidance that Enhances MESA Platform Using Patient-Specific Rods & Rails [Sudan Tribune]
-K2M Group Holdings, Inc., a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, today announced at the Scoliosis Research Society 53rd Annual Meeting& Course, in Bologna, Italy a U.S. Food and Drug Administration 510 clearance that also provides for the Dual Differential Correc
10/11/18 - Non-small cell lung cancer patients see improved survival with durvalumab
By a News Reporter-Staff News Editor at Clinical Trials Week TAMPA, Fla. Non-small cell lung cancer patients survive longer when their treatment includes durvalumab following platinum-based chemoradiotherapy, according to research led by Moffitt Cancer Center. Manufactured by AstraZeneca, durvalumab received initial FDA approval in 2017 for loc
10/11/18 - Rising Biosciences Receives FDA Clearance for TSW Pain Cream; Expedites Testing of CBD Only Variants of Cannophen and TSW Pain Cream Products [T-break Tech (Middle East)]
The past 30 days have been very exciting for our industry, states Rising Biosciences COO Arthur Hall. As well, on October 17th, 2018, Marijuana becomes legal in Canada as a result of The Cannabis Act, passed on June 3rd, 2018, marking Canada as the first G7 country to legalize Marijuana. Rising Biosciences has decided to seek registration as a fore
10/11/18 - TransEnterix Receives FDA 510(k) Clearance for 3mm Diameter Instruments
TransEnterix, Inc., a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that the Company received FDA 510 clearance for 3 millimeter diameter instruments, as well as additional 5 millimeter Senhance System instruments. The ability to perform...
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