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
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
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
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,
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
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
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
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
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
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
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.
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
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
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...
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,
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
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
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.
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
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.
-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
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
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
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...