Addivant?, the world leading supplier of liquid phosphite antioxidants for plastics, announced today that its nonylphenol-free stabilizer, WESTON 705, has received formal approval from the US Food and Drug Administration for use in infant formula and human milk plastic packaging. This approval from the FDA for use in infant formula and human m
By a News Reporter-Staff News Editor at Pharma Business Week- Alere Inc., a global leader in rapid diagnostics, announced that its Alere? Reader, a diagnostic analyzer that can be used in both point-of-care and laboratory settings, has received 510 marketing clearance from the US Food and Drug Administration. This reformulated test card is the
By a News Reporter-Staff News Editor at Clinical Trials Week ArQule, Inc. announced that it has received clearance from the U.S. Food and Drug Administration for the Investigational New Drug application to conduct a phase 1 clinical trial with ARQ 531 in patients with B-cell malignancies who are refractory to other therapeutic options.
Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, has been selected by TESARO, Inc. to be a specialty pharmacy provider in the distribution network for ZEJULA TM. Approved by the U.S. Food and Drug Administration on March 27, 2017, ZEJULA is a poly ADP-ribose polymerase inhibitor, for the maintenance treatment of adul
Clinigen Group plc. s Idis Managed Access division and Onxeo S.A, have agreed to launch a Managed Access programme for belinostat in Europe. The product received accelerated approval* by the US Food and Drug Administration in July 2014 due to the unmet medical need in this rare disease. Steve Glass, Chief Commercial Officer, North America and
TEL AVIV, ISREAL/ ACCESSWIRE/ April 24, 2017/ Elbit Imaging Ltd. announced today, in furtherance to the announcements dated on October 22, 2015 and July 12, 2016, that it was informed by INSIGHTEC Ltd., that the FDA has extended its approval of Exablate Neuro system for a non-invasive treatment of essential tremor in patients who have not responded
PARIS- Sanofi said the US Food& Drug Administration approved Thymoglobulin for use in conjunction with concomitant immunosuppression in the prophylaxis, or prevention, of acute rejection in patients receiving a kidney transplant. The FDA approval was based on two randomised multicentre studies comparing Thymoglobulin to interleukin-2 receptor...
By a News Reporter-Staff News Editor at Mental Health Weekly Digest Neurocrine Biosciences, Inc. announced that the U.S. Food and Drug Administration has approved INGREZZATM capsules for the treatment of adults with tardive dyskinesia. INGREZZA, a novel, selective vesicular monoamine transporter 2 inhibitor, is the first and only FDA- approved pr
By a News Reporter-Staff News Editor at Pharma Business Week HYPERLINK " http://www.philips.com/"\ nRoyal Philips, a global leader in health technology, announced it has received regulatory clearance from the U.S. Food and Drug Administration to market its HYPERLINK " http://www.usa.philips.com/healthcare/solutions/pathology"\ nIntelliSite Pathol
INCHEON, Korea Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration has approved RENFLEXIS?, a biosimilar referencing Remicade i, across all eligible indications. Samsung Bioepis headquarters in Incheon, Korea. Samsung Bioepis infliximab biosimilar has also been approved for marketing in 28 European Union
Sanofi today announced that the U.S. Food and Drug Administration approved Thymoglobulin , for use in conjunction with concomitant immunosuppression in the prophylaxis, or prevention, of acute rejection in patients receiving a kidney transplant. "Thymoglobulin has been a well-established medication used in kidney transplantation for nearly 20
PARIS- Sanofi said that the U.S. Food and Drug Administration approved Thymoglobulin, for use in conjunction with concomitant immunosuppression in the prophylaxis, or prevention, of acute rejection in patients receiving a kidney transplant. The FDA approval was based on two randomized multicenter studies comparing Thymoglobulin to interleukin-2...
By a News Reporter-Staff News Editor at Clinical Trials Week Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration has approved supplemental indications for Harvoni tablets and Sovaldi tablets for the treatment of chronic hepatitis C virus infection in adolescents without cirrhosis or with compensated cirrhosis, 12 year
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA New Haven, Conn. The U.S. Food and Drug Administration reviews and approves new medicines in a shorter timeframe than its peer agency in Europe, the European Medicines Agency, says a Yale researcher. This finding, which comes at a time when the FDA is under renewed pressure
By a News Reporter-Staff News Editor at Heart Disease Weekly BOSTON, NEW YORK, and MELBOURNE, Australia, Boston Children's Hospital, the pediatric teaching hospital of Harvard University, and Mesoblast Limited announced that the United States Food and Drug Administration has cleared the commencement of a 24- patient trial combining Mesoblast's.
By a News Reporter-Staff News Editor at Heart Disease Weekly AstraZeneca announced that the US Food and Drug Administration has granted full approval for TAGRISSO 80 mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer, as detected by an FDA- ap
This is the first FDA product release for electroCore in the U.S.. "Cluster headache is a rare, debilitating and difficult to treat disorder with few effective acute therapies, said Stephen Silberstein, MD, Director, Headache Center, Jefferson University, Philadelphia, PA." The FDA release of gammaCore is an important advance in the treatment of t
This week, Pharma major Glenmark Pharma has received tentative approval from the United States Food& Drug Administration to sell Pradaxa Drug used to prevent blood clots. Top News. Unichem Laboratories Limited on Monday announced that for Piroxicam Capsules USP 10 mg& 20 mg, it has received ANDA approval from the United States Food and Drug A
Steve Stivers, R- Ohio, has introduced the Speeding Access to Already Approved Pharmaceuticals Act to "require the Food and Drug Administration to expedite review of pharmaceuticals that are approved for marketing in the European Union." Steve Stivers in Washington at 1022 Longworth House Office Building, Washington, DC 20515; 202/ 225-2015; or in
Kirkland, Wash.- based Cardiac Insight is hoping to break into that market with Cardea Solo, a lightweight disposable electrocardiogram test that monitors a patients heartbeat. The company has raised $4.5 million to develop and commercialize the device and announced today that it has been approved for use by the FDA and is now available to healthca
The U.S. Food and Drug Administration approved Renflexis, developed by Samsung Bioepis Co. of South Korea. Its U.S. partner, Merck& Co. of Kenilworth, New Jersey, will market Renflexis. The first biosimilar for Remicade, Inflectra from New York- based Pfizer Inc., went on sale in November at a 15 percent discount.
Cluster headaches, though rare, are among the most severe forms of headache a person can face. The U.S. Food and Drug Administration said it has approved a hand-held device to treat these attacks. "Although they are uncommon, affecting about 1 in 2,000, they are severe, disabling and poorly understood," said Rosen, who directs Northwell Health`s H
Calgary, Alberta- Imaging Dynamics Company Ltd. is pleased to announce that it received notification that Health Canada has approved its Digital Radiography products- Aquarius 8600 1717 TC and Aquarius 8600 1417 TC for sale in Canada. These products were also approved by the United States Food and Drug Administration on February 22, 2017 for sales
Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product, which is used in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults.Perphenazine tablets had U.S. sales of approximately $41 million for the 12 months ending Feb. 28, according t