New Research Leads to FDA Approval of First Drug to Treat Radiation Sickness
BALTIMORE, May 22, 2015 /PRNewswire-USNewswire/ -- As a result of research performed by scientists at the University of Maryland School of Medicine (UM SOM), the U.S. Food and cialis samples in canada Drug Administration has approved the use of a drug to treat the deleterious effects of radiation exposure...
Janssen reçoit un avis favorable de la part du CHMP à la recommandation d'IMBRUVICA® (Ibrutinib) pour le traitement de la macroglobulinémie de Waldenström
BEERSE, Belgique, May 22, 2015 /PRNewswire/ --
Ce communiqué de presse a été rédigé en Anglais. Des traductions en Allemand, Français et Espagnol sont fournies par PR Newswire pour servir à la clientèle internationale.
Un type rare de...
Janssen erhält positive Stellungnahme des CHMP, das IMBRUVICA® (Ibrutinib) zur Behandlung von Morbus Waldenström empfiehlt
BEERSE, Belgien, May 22, 2015 /PRNewswire/ --
Die Originalsprache dieser Pressemitteilung ist Englisch. Übersetzungen ins Deutsche, Französische und Spanische werden von PR Newswire als besonderer Service für seine Kunden angeboten.
Ein seltenes B-Zell-Lymphom, für...
Janssen recibe comentarios positivos del CHMP al recomendar IMBRUVICA® (Ibrutinib) para el tratamiento de la macroglobulinemia de Waldenström
BEERSE, Bélgica, May 22, 2015 /PRNewswire/ --
Este comunicado de prensa está originalmente escrito en inglés. PR Newswire proporciona las traducciones en alemán, francés y español como servicio a sus clientes.
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Tris Pharma Announces the FDA Acceptance of NDA for Dyanavel™ XR
MONMOUTH JUNCTION, N.J., May 21, 2015 /PRNewswire/ -- Tris Pharma, Inc. ("Tris") announced that U.S. Food and Drug Administration ("FDA") has accepted for review its New Drug Application ("NDA") for Dyanavel XR (amphetamine) CII, an Extended-Release Oral Suspension. The FDA has set a...
Emmes Announces FDA Clearance of New Medical Device
ROCKVILLE, Md., May 20, 2015 /PRNewswire/ -- The Emmes Corporation today announced that the U.S. Food and Drug Administration (FDA) has given marketing clearance for a new device that allows doctors to more accurately assess children's weight without the use of a weight scale. Weight...
Cynosure Receives FDA 510(k) Clearance for SculpSure™, the World's First Hyperthermic Laser Treatment for Non-Invasive Fat Reduction
WESTFORD, Mass., May 19, 2015 /PRNewswire/ -- Cynosure, Inc. (NASDAQ: CYNO) a leader in laser- and light-based aesthetic treatments, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SculpSure™, the world's first...
U.S. FDA Approves INVEGA TRINZA™, First and cialis express delivery mexico viagra Only Four-Times-A-Year Treatment for Schizophrenia
TITUSVILLE, N.J., May 19, 2015 /PRNewswire/ -- There's a new treatment option for schizophrenia – INVEGA TRINZA™ (three-month paliperidone palmitate), the first and only schizophrenia medication to be administered just four times a year, providing the longest dosing...
FDA Grants Premarket Approval for Silk Road Medical's ENROUTE® Transcarotid Stent System
SUNNYVALE, Calif., May 19, 2015 /PRNewswire/ -- Silk Road Medical, Inc., a pioneer in the development of transcarotid therapies for intra and viagra tablet weight extracranial vascular diseases, announces the company has received Premarket Approval (PMA) from the United States Food & Drug...
AbbVie Receives Orphan Drug Designation for HUMIRA® (adalimumab) from the U.S. Food and Drug Administration for the Investigational Treatment of Moderate-to-Severe Hidradenitis Suppurativa (HS)
NORTH CHICAGO, Ill., May 15, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has granted HUMIRA® (adalimumab) orphan drug designation for the investigational treatment of moderate-to-severe hidradenitis suppurativa (HS) (Hurley...
D-Pharm Receives Final Report for Its Phase 2 Clinical Study of THR-18 in Acute Stroke Patients Treated With tPA
REHOVOT, Israel, May 14, 2015 /PRNewswire/ --
D-Pharm Ltd. (TASE: DPRM) reported today, May 14th, 2015, that it has received the final report for its Phase 2 clinical study of THR-18. THR-18 demonstrated statistically significant reductions in the incidence of intracranial hemorrhage...
PENTAX Medical Reaffirms Commitment to Work with FDA and Industry Partners To Address Duodenoscope Infection Issues
MONTVALE, N.J., May 14, 2015 /PRNewswire/ -- As the FDA Advisory Panel on Gastroenterology and best price doxycycline Urology Devices Panel of the Medical Devices Advisory Committee prepares to meet, PENTAX Medical affirms its commitment to work with the FDA, industry partners and best price cytotec the medical community to...
Protein Sciences New York Facility Receives FDA Licensure to Manufacture Flublok®
MERIDEN, Conn., May 13, 2015 /PRNewswire/ -- Protein Sciences Corporation announced that on May 12, 2015 the U.S. Food and Drug Administration (FDA) licensed its Pearl River, NY manufacturing facility for the commercial manufacturing of Flublok® influenza vaccine. Flublok...
COPAN is Proud to Announce FDA Clearance for FecalSwab™ to Standardize and orlistat side effects Simplify Enteric Culture and buy viagra online uk next day delivery Molecular Diagnostics
MURRIETA, Calif., May 13, 2015 /PRNewswire/ -- COPAN, an innovative company focused on bringing breakthrough products to Microbiology preanalytics around the world, announced that it has obtained FDA clearance for its new FecalSwab™.
FecalSwab™ comprises of a regular...
Accutest Recently Completed its 22nd Successful FDA Inspection
MUMBAI, May 13, 2015 /PRNewswire/ --
During the period April 6th to 8th 2015, Accutest successfully completed its 22nd USFDA inspection without receiving any form 483. Accutest is a leading global independent CRO with a track record of more than 2,200 studies and viagra price comparison 76 inspections from...
Itamar Medical Offers a Total Sleep Apnea Management Solution to Cardiologists
FRANKLIN, Massachusetts, May 13, 2015 /PRNewswire/ --
For the first time, the company will manage and coordinate all stages of diagnosis and canadain viagra treatment for hospitals
In light of the growing evidence of the link between cardiovascular disease and buy generic finasteride obstructive sleep apnea...
BD Receives FDA Clearance for a Novel Infusion Set with BD FlowSmart™ Technology to Enhance the Use of Insulin Pumps
Unique Side-Ported Catheter Designed to Offer Consistent Insulin Delivery and canadian healthcare viagra Fewer Flow Interruptions including Silent Occlusions
Infusion Set Developed in Collaboration with JDRF and Helmsley Charitable Trust
FRANKLIN LAKES, N.J., May 13, 2015 /PRNewswire/ -- BD Medical, a...
MicroBiome Therapeutics Receives Positive Response From FDA For Use Of Expedited Regulatory Pathway For Diabetes Drug NM505
BROOMFIELD, Colo., May 12, 2015 /PRNewswire/ -- MicroBiome TherapeuticsTM LLC, (MBT) today reported that the U.S. Food & Drug Administration (FDA) has responded positively to the company's pre-IND request to use the 505(b)(2) abbreviated regulatory pathway for development of lead...
Merck KGaA, Darmstadt, Germany, Receives FDA Fast Track Designation for Evofosfamide for the Treatment of Patients Living With Advanced Pancreatic Cancer
ROCKLAND, Massachusetts, May 12, 2015 /PRNewswire/ --
Evofosfamide is an investigational compound currently in Phase III trials
Advanced pancreatic cancer is second indication to receive FDA fast track designation for evofosfamide
Merck KGaA, Darmstadt, Germany, a leading...
FDA Performs GMP and Pre-Approval Inspections of Impax's Hayward Facility
HAYWARD, Calif., May 11, 2015 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) performed a three week inspection of the Company's Hayward, California manufacturing facility. This inspection included a general GMP...
FDA approves a new ultrasound imaging agent
The U.S. Food and Drug Administration today approved Lumason (sulfur hexafluoride lipid microsphere) for patients whose ultrasound image of the heart (echocardiograms) are hard to see with ultrasound waves.
FDA approves first combination pill to treat hepatitis C
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and soft cialis sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.
FDA approves first drug-coated angioplasty balloon catheter to treat vascular disease
The U.S. Food and Drug Administration today approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). This is the first drug-coated balloon used to re-open arteries in the thigh (superficial femoral arteries) and knee (popliteal arteries) when narrowed or blocked as a result of peripheral artery disease (PAD).
FDA approves Akynzeo for nausea and vomiting associated with cancer chemotherapy
The U.S. Food and Drug Administration today approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy.
FDA seeks permanent injunction against Pharmaceutical Innovations, Inc.
The U.S. Food and Drug Administration is seeking a permanent injunction to stop Pharmaceutical Innovations Inc., and its principal officer, Gilbert Buchalter, from manufacturing, marketing, selling, and distributing medical products until they come into compliance with all applicable FDA requirements.
The FDA takes steps to strengthen cybersecurity of medical devices
To strengthen the safety of medical devices, the U.S. Food and Drug Administration today finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.
FDA awards grants to stimulate drug, device development for rare diseases
The U.S. Food and Drug Administration today announced it has awarded 15 grants totaling more than $19 million to boost the development of medical device, drug, and biological products for patients with rare diseases, with at least a quarter of the funding going to studies focused solely on pediatrics.
U.S. Marshals seize botanical substance kratom from southern California facility
U.S. Marshals at the request of the U.S. Food and Drug Administration today seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, California.
NIH and FDA win top award for intellectual property licensing of meningitis vaccine
The National Institutes of Health and the U.S. Food and Drug Administration will receive a top national award for the year’s most outstanding intellectual property licensing deal, for technology transfer of a pioneering, low-cost meningitis vaccine launched in sub-Saharan Africa. The 2014 Deals of Distinction Award will be presented to the two federal agencies and their collaborators by the Licensing Executives Society at the society’s 50th annual meeting, Oct. 5-8 in San Francisco.
FDA clears glucose monitoring system for use in hospital critical care units
Today the U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. This is the first blood glucose monitoring system (BGMS) cleared by FDA for use in these patients.
FDA food safety challenge to spur new technologies for fighting foodborne illness
The U.S. Food and Drug Administration is asking for potential breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce.
FDA allows marketing of the first test to identify five yeast pathogens directly from a blood sample
The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei.
FDA releases updated proposals to improve food safety and help prevent foodborne illness in response to public comments
Based on extensive outreach and public comment, the U.S. Food and Drug Administration today proposed revisions to four proposed rules designed to help prevent food-borne illness. When finalized, the proposed rules will implement portions of the FDA Food Safety Modernization Act (FSMA), which aims to strengthen food safety by shifting the focus to preventing food safety problems rather than responding to problems after the fact.
FDA approves Trulicity to treat type 2 diabetes
The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.
FDA approves Movantik for opioid-induced constipation
The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.
FDA approves weight-management drug Contrave
The U.S. Food and Drug Administration today approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas
The U.S. Food and Drug Administration is reminding health care professionals and consumers about safety concerns with all sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas, Texas. Health care professionals should not use any NuVision/Downing Labs sterile products for their patients because the firm cannot ensure the safety or quality of these products. Administration of a non-sterile drug product may result in serious and potentially life-threatening infection or death.
FDA allows marketing of the first test to assess risk of developing acute kidney injury
Today the U.S. Food and Drug Administration allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following the administration of the test. Early knowledge that a patient is likely to develop AKI may prompt closer patient monitoring and help prevent permanent kidney damage or death.
U.S. Marshals seize drug products from Flawless Beauty
Various unapproved and improperly labeled drug products that were marketed, sold and distributed via the Internet by Flawless Beauty LLC, of Asbury Park, New Jersey, have been seized by U.S. Marshals at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the District of New Jersey. These products, including injectable drug products, were marketed, sold and distributed to individuals, retail outlets, health spas and clinics.
FDA approves Keytruda for advanced melanoma
The U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.