NeuroDerm Ltd. Files Registration Statement for Proposed Initial Public Offering
REHOVOT, Israel, September 15, 2014 /PRNewswire/ --
NeuroDerm Ltd., a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced that it has filed a registration statement on Form F-1 with the U.S. Securities and viagra discount Exchange Commission...
Cochlear Announces the FDA Approval of True 2.4 GHz Wireless Connectivity With the Cochlear™ Nucleus® 6 Sound Processor
CENTENNIAL, Colo., Sept. 15, 2014 /PRNewswire/ -- Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announced today that the US Food and generic viagra us Drug Administration (FDA) approved the use of 2.4 GHz wireless connectivity with the Cochlear™ Nucleus® 6...
Shire Announces FDA Acceptance for Filing with Priority Review of Supplemental New Drug Application (sNDA) for Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) for Adults with Binge Eating Disorder
PHILADELPHIA, September 15, 2014 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has accepted for filing with priority review a supplemental New Drug Application (sNDA) for...
FDA accepts Tuzistra™ XR (CCP-01) NDA for full review
MONMOUTH JUNCTION, N.J., Sept. 15, 2014 /PRNewswire/ -- Vernalis plc (LSE: VER) and Tris Pharma, Inc. ("Tris") are pleased to announce that the U.S. Food and Drug Administration ("FDA") has confirmed that the New Drug Application ("NDA") for Tuzistra™ XR ("CCP-01") has...
FDA Approves New Styles Of The MENTOR® MemoryShape® Silicone Breast Implant
SANTA BARBARA, Calif., Sept. 15 2014 /PRNewswire/ -- Mentor Worldwide LLC, the U.S. market leader in breast aesthetics, today announced the U.S. Food and Drug Administration (FDA) has approved four additional styles of the MENTOR® MemoryShape® Breast Implants, expanding its...
La FDA des États-Unis approuve l'utilisation du XTANDI® (enzalutamide) en capsules pour le traitement du cancer métastatique de la prostate résistant à la castration
SAN FRANCISCO et TOKYO, September 12, 2014 /PRNewswire/ --
Cette approbation repose sur une amélioration globale de la survie, un retard de progression radiographique et un profil avantage-risque globalement positif
Medivation, Inc. (Nasdaq : MDVN) et Astellas Pharma...
US-Bundesbehörde FDA genehmigt neue Indikation zur Anwendung von XTANDI® (Enzalutamid) in Kapselform bei Patienten mit metastasierendem kastrationsresistentem Prostatakrebs
SAN FRANCISCO und TOKIO, September 12, 2014 /PRNewswire/ --
Genehmigung wird mit erhöhter Gesamtüberlebensrate, verzögerter radiografischer Progression und einem insgesamt positiven Nutzen-Risiko-Profil begründet
Medivation, Inc. (Nasdaq:...
Synthetic Biologics Receives Orphan Drug Designation for SYN-005 Treatment for Whooping Cough (Pertussis)
ROCKVILLE, Md., Sept. 12, 2014 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a biotechnology company developing novel anti-infective biologic and canadian pharmacy drug programs targeting specific pathogens that cause serious infections and discount brand name cialis diseases, announced today that the U.S. Food and...
La FDA aprueba una nueva indicación para las cápsulas XTANDI® (enzalutamida) en pacientes con cáncer de próstata
SAN FRANCISCO y TOKIO, September 12, 2014 /PRNewswire/ --
- La FDA de Estados Unidos aprueba una nueva indicación para el uso de las cápsulas XTANDI® (enzalutamida) en pacientes con cáncer de próstata metastático resistente a la...
7 Things About Artificial Hearts That You Should Know
TUCSON, Ariz., Sept. 12, 2014 /PRNewswire/ -- Cardiovascular disease, which includes heart failure, is the number one cause of death, killing more people worldwide than all cancers combined.
The need for donor hearts is growing as heart disease continues to claim an increasing portion...
ADAMA Achieves U.S. Registration for Novel NIMITZ[TM] Nematicide
TEL AVIV, Israel, September 12, 2014 /PRNewswire/ --
ADAMA Agricultural Solutions, a world leader in farmer-centric agricultural solutions, announced today that NIMITZ, a novel, non-fumigant nematicide with unprecedented user safety and buy viagra online simplified application features, has achieved...
FDA approves PleximmuneTM for personalized prediction of transplant rejection in children
PITTSBURGH, Sept. 11, 2014 /PRNewswire-iReach/ -- Today the FDA announced approval of PleximmuneTM, a blood test from the Pittsburgh-based biotech company Plexision. This test predicts acute cellular rejection of transplanted livers and cialis samples in canada intestines in children. PleximmuneTM is a...
IMRIS neurosurgical HFD rocker arm receives FDA clearance
Head fixation device (HFD) accessory provides skull stabilization for more patient head sizes
MINNEAPOLIS, Sept. 11, 2014 /PRNewswire/ - IMRIS Inc. (NASDAQ: IMRS; TSX: IM)
("IMRIS" or the "Company") today announced a new rocker arm accessory
that expands choices for neurosurgeons to...
Takeda and how to get viagra Orexigen Announce FDA Approval of Contrave® (naltrexone HCI and bupropion HCI) Extended-release Tablets for Chronic Weight Management
DEERFIELD, Ill., and LA JOLLA, Calif., Sept. 11, 2014 /PRNewswire/ -- Takeda Pharmaceuticals U.S.A., Inc. and Orexigen® Therapeutics, Inc. (Nasdaq: OREX) jointly announced today that the U.S. Food and Drug Administration (FDA) has approved Contrave® (naltrexone HCI and...
FDA approves weight-management drug Contrave
The U.S. Food and Drug Administration today approved Contrave (naltrexone hydrochloride and cialis by mail bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and overnight canadian viagra physical activity.
U.S. FDA Approves New Indication for the Use of XTANDI® (enzalutamide) Capsules for Patients with Metastatic Castration-Resistant Prostate Cancer
TOKYO and SAN FRANCISCO, Sept. 10, 2014 /PRNewswire/ -- Astellas Pharma Inc. (Tokyo: 4503) and Medivation, Inc. (Nasdaq: MDVN) announced today that the U.S. Food and Drug Administration (FDA) approved a new indication for the use of XTANDI® (enzalutamide) capsules to treat...
Merck & Co.'s Keytruda is Approved in the United States for the Treatment of Advanced and viagra non prescription Unresectable Malignant Melanoma
BURLINGTON, Mass., Sept. 10, 2014 /PRNewswire/ -- The recent approval of Merck & Co.'s Keytruda by the U.S. Food and Drug Administration for the treatment of malignant melanoma is a significant milestone for Merck & Co. and for the oncology immunotherapy drug market. Decision...
Glen Tullman Launches Livongo Health™ to Empower Consumers with Chronic Conditions to Live Better, Beginning with Diabetes
PALO ALTO, Calif., Sept. 10, 2014 /PRNewswire/ -- Livongo Health™, a consumer digital health company, launched today with a vision to empower people with chronic conditions to live better through the combined power of technology, real-time personalized information, and support...
Global Kinetics Corporation Announces FDA Clearance of the Personal KinetiGraph™ for Assessment of Parkinson's Disease Symptoms
MELBOURNE, Australia, Sept. 10, 2014 /PRNewswire/ -- Global Kinetics Corporation, a leading mobile health technologies company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the marketing of the company's Personal KinetiGraph™ (PKG™) technology...
BioLight Announces First IOPtiMate™ System Sale in Hong Kong
TEL AVIV, Israel, September 10, 2014 /PRNewswire/ --
BioLight Life Sciences Investments Ltd. (TASE: BOLT, OTCQX:BLGTY), a firm that invests in, manages and cialis 20 mg commercializes biomedical innovations in ophthalmology and cialis online generic cancer diagnostics, announces the first sale of an...
Beta-O2 Receives Grant from JDRF to Advance Clinical Development of the ßAir Bio-artificial Pancreas as a Potential Cure for Type 1 Diabetes
ROSH HA-AYIN, Israel, September 10, 2014 /PRNewswire/ --
Beta-O2 announced today that it has received a $500K grant from JDRF. The grant will be used to help fund a $1M pilot human study of Beta-O2's ßAir bio-artificial pancreas, in development as a treatment and best price for cialis potential cure for...
FDA Advisory Committee Recommends Against Approval of Actavis' Nebivolol/Valsartan Fixed-Dose Combination NDA for Treatment of Hypertension
DUBLIN, Sept. 9, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted to recommend against approval of Actavis' New Drug Application (NDA) for the fixed-dose...
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.
New Prevantics® Device Swab from PDI Receives FDA 510k Market Authorization
ORANGEBURG, N.Y., Sept. 9, 2014 /PRNewswire/ -- PDI, manufacturer of market-leading infection prevention products and solutions, announced the introduction of Prevantics® Device Swab, the only Chlorhexidine Gluconate/alcohol solution that has received market authorization...
The Female Health Company Brings Together Advocates and Experts To Advance The FC2 Female Condom
CHICAGO, Sept. 9, 2014 /PRNewswire/ -- The Female Health Company (NASDAQ - CM: FHCO), maker of the world's leading female condom, today announced the launch of its vibrant new packaging for the FC2 Female Condom® (FC2) in the United States.
On Global Female Condom Day,...
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.
FDA takes action against Georgia dietary supplement manufacturer
A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments for disease, and to terminate the sale of supplements until the company complies with the U.S. Food and Drug Administration’s manufacturing regulations and other requirements. A federal judge issued the injunction against BioAnue Laboratories of Rochelle, Georgia, and its owner/operators, Gloria and Kelly Raber.
FDA allows marketing of first ZnT8Ab autoantibody test to help diagnose type 1 diabetes
Today, the U.S. Food and Drug Administration allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive timely diagnosis and treatment for their disease.
FDA approves new drug to treat a form of Gaucher disease
The U.S. Food and Drug Administration today approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder.
Turkish man pleads guilty to importing illegal cancer drugs
Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer
The U.S. Food and Drug Administration today approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.
FDA warns consumers about fraudulent Ebola treatment products
The U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection.
FDA approves new type of sleep drug, Belsomra
The U.S. Food and Drug Administration today approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).
FDA approves donor lung preservation device that may result in more lung transplants
Today, the U.S. Food and Drug Administration approved the XVIVO Perfusion System (XPS) with STEEN Solution, a device for preserving donated lungs that do not initially meet the standard criteria for lung transplantation but may be transplantable if there is more time to observe and evaluate the organ’s function to determine whether the lung is viable for transplantation.
FDA seeks permanent injunction against Michigan cheese manufacturer
On August 8, 2014, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Eastern District of Michigan against S. Serra Cheese Company, of Clinton Township, Michigan, and its owners, Stefano Serra and Fina Serra.
FDA approves first non-invasive DNA screening test for colorectal cancer
The U.S. Food and Drug Administration today approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.
FDA approves Orbactiv to treat skin infections
The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
FDA expands approval of drug to treat Pompe disease to patients of all ages; removes risk mitigation strategy requirements
The U.S. Food and Drug Administration today announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age. In addition, the Risk Evaluation and Mitigation Strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program is being eliminated.
FDA approves Jardiance to treat type 2 diabetes
The U.S. Food and Drug Administration today approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes.
FDA approves Striverdi Respimat to treat chronic obstructive pulmonary disease
Today, the U.S. Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema that are experiencing airflow obstruction. Striverdi Respimat can be used once daily over a long period of time.
FDA takes steps to help ensure the reliability of certain diagnostic tests
Today, the U.S. Food and Drug Administration took important steps to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent and reliable results.