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FDA Advisory Committee Recommends Approval of Qnexa®
MOUNTAIN VIEW, Calif., Feb. 22, 2012 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in...
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Boston Scientific Receives Industry's First FDA Approval for Drug-Eluting Coronary Stent Use in Heart Attack Patients
NATICK, Mass., Feb. 22, 2012 /PRNewswire/ -- Boston Scientific Corporation's (NYSE: BSX) ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System and TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent System have received U.S. Food and Drug Administration (FDA)...
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Federal government gains permanent injunction against raw milk producer
A federal court has granted the U.S. Food and Drug Administration a permanent injunction preventing Daniel L. Allgyer and his Rainbow Acres Farm from distributing raw milk and raw milk products in final package form for human consumption across state lines.
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FDA Taken to Task by Prominent Oral Surgeon
DENVER, Feb. 22, 2012 /PRNewswire/ -- "FDA, You Were WRONG!" is an eye-opening account of how the FDA agency of the federal government, which is supposedly there to help protect the public, has actually been doing more harm than good in recent years; this is the story of Dr. Bob...
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Bill Gates anima a los líderes españoles a mantener la inversión en cooperación exterior
MADRID, February 22, 2012 /PRNewswire/ --
- Durante su visita de hoy a Madrid, Gates se reunirá con el Presidente del Gobierno Mariano Rajoy y el Ministro de Asuntos Exteriores y de Cooperación José Manual García-Margallo.
Bill Gates, copresidente de la...
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FDA acts to bolster supply of critically needed cancer drugs
The U.S. Food and Drug Administration today announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama's Executive Order to help prevent future drug shortages.
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Enanta Enters Into Strategic Collaboration to Advance NS5A Inhibitor Candidate for HCV
WATERTOWN, Mass., Feb. 21, 2012 /PRNewswire/ -- Enanta Pharmaceuticals, Inc., a research and development company dedicated to creating best-in-class small molecule drugs in the infectious disease field, announced today that it has entered into an exclusive collaboration and license...
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Clarity 3D Ultrasound Innovation Offers Remote Automatic Scanning to Guide Prostate Cancer Radiation Therapy
ATLANTA, Feb. 20, 2012 /PRNewswire/ -- Clarity® soft tissue visualization system now provides an Autoscan option for automated ultrasound scanning from outside of the treatment room, employing a motorized probe positioned at the patient's perineum. The transperineal approach...
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FDA Approves Korlym for Patients With Endogenous Cushing's Syndrome
 SILVER SPRING, Md., Feb. 17, 2012 /PRNewswire-USNewswire/ -- Today, Korlym (mifepristone) was approved by the U.S. Food and Drug Administration to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing's syndrome. This drug was approved for use in patients with...
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Elekta's Fraxion System Brings Proven Immobilization Options Into One Single Solution for Stereotactic Radiation Therapy of the Brain and Cranium
ATLANTA, Feb. 17, 2012 /PRNewswire/ -- The Fraxion™ head frame helps ensure accuracy and precision in stereotactic radiation therapy (SRT) of cancer targets in the brain and cranium. Elekta's Fraxion is the first to introduce an innovative system that integrates all proven...
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Die US-Lebensmittelüberwachung- und Arzneimittelzulassungsbehörde FDA genehmigt das von Gen-Probe eingeführte Testverfahren PROGENSA® PCA3, das erste auf Urin basierende molekulare Testverfahren, das dabei behilflich ist, zu ermitteln, ob wiederholt
SAN DIEGO, February 16, 2012 /PRNewswire/ --
-- Der Test reduziert möglicherweise die unnötige Wiederholung von Prostatabiopsien --
Gen-Probe (NASDAQ: GPRO) ließ heute verlauten, dass die US-Lebensmittelüberwachung- und Arzneimittelbehörde, die US Food and Drug...
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La FDA approuve le test de PROGENSA® PCA3 de Gen-Probe, le premier test moléculaire d'urine visant à évaluer la nécessité de reprise de biopsie de la prostate
SAN DIEGO, February 16, 2012 /PRNewswire/ --
-- Ce test pourrait diminuer les reprises de biopsies --
Gen-Probe (NASDAQ: GPRO) annonce aujourd'hui que la FDA a approuvé le test PROGENSA PCA3 (gène du cancer de la prostate 3), le premier test moléculaire aidant à...
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CSL Behring Receives FDA Orphan Drug Designation for rVIIa-FP, a Novel Therapy in Development to Treat Hemophilia A and Hemophilia B Patients Who Have Inhibitors
KING OF PRUSSIA, Pa., Feb. 16, 2012 /PRNewswire/ -- CSL Behring announced today that the company has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its novel recombinant fusion protein linking coagulation factor VIIa with albumin...
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La FDA aprueba el ensayo PROGENSA® PCA3 de Gen-Probe
SAN DIEGO, February 15, 2012 /PRNewswire/ --
La FDA aprueba el ensayo PROGENSA® PCA3 de Gen-Probe, se trata del primer test molecular basado en la orina para ayudar a determinar la necesidad de repetirlas biopsias de próstata
-- El test podría ayudar a reducir las...
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Children's Hospital of Michigan Cardiovascular Surgeon Testifies on Berlin Heart, now Approved by the FDA
DETROIT, Feb. 15, 2012 /PRNewswire-USNewswire/ -- Few hospitals have as much experience with the Berlin Heart as DMC Children's Hospital of Michigan. This is why the U.S. Food and Drug Administration (FDA) was eager to hear testimony from Henry L. Walters III, MD, chief of cardiovascular...
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FDA Approves Additional Manufacturer of Methoxsalen
BRIDGEWATER, N.J., Feb. 15, 2012 /PRNewswire/ -- The FDA has approved the addition of a secondary supplier of Methoxsalen USP, an integral component of a treatment for the relief of moderate to severe psoriasis prescribed under the brand name Oxsoralen-Ultra® (methoxsalen) Capsules,...
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FDA approves PROGENSA® PCA3 assay
First Urine-Based Molecular Test to Help Determine Need for Repeat
Prostate Biopsies
Test May Help Reduce Unnecessary Repeat Prostate Biopsies
QUEBEC CITY, Feb. 15, 2012 /PRNewswire/ - DiagnoCure, Inc. (TSX: CUR), a
Quebec life sciences company that develops and commercializes...
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FDA Approves Gen-Probe's PROGENSA® PCA3 Assay, First Urine-Based Molecular Test to Help Determine Need for Repeat Prostate Biopsies
 SAN DIEGO, Feb. 15, 2012 /PRNewswire/ -- Gen-Probe (NASDAQ: GPRO) announced today the US Food and Drug Administration (FDA) has approved its PROGENSA® PCA3 (Prostate Cancer gene 3) assay, the first molecular test to help determine the need for repeat prostate biopsies in men who...
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Mylan Actively Addressing Shortage of Preservative-Free Methotrexate Injection
PITTSBURGH, Feb. 14, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today commented on its response to the current shortage of preservative-free Methotrexate Injection.
Mylan CEO Heather Bresch said, "We recognize the critical importance of preservative-free Methotrexate Injection in...
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FDA approves Zioptan to treat elevated eye pressure
On February 10, the U.S. Food and Drug Administration approved Zioptan (tafluprost ophthalmic solution) to help reduce elevated eye pressure in people with open-angle glaucoma.
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Nationally Recognized Glenveigh Medical Announces Orphan Drug Designation for Treatment for Severe Preeclampsia and Eclampsia
CHATTANOOGA, Tenn., Feb. 14, 2012 /PRNewswire/ -- Glenveigh Medical announced today that the U.S. Food and Drug Administration (FDA) has granted its request for orphan drug designation for a potential new therapy to treat severe preeclampsia and eclampsia. The compound,...
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FDA Grants Petition for Removal From Import Alert
DETROIT, Feb. 14, 2012 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) maintains strict labeling requirements for Active Pharmaceutical Ingredients (APIs). If an API does not maintain adequate labeling as per section 502(f)(1) of the Act, the FDA will consider the...
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FDA seeks $4.5 billion to support medical product development, protect patients and ensure safety of the food supply
The U.S. Food and Drug Administration is requesting a budget of $4.5 billion to protect and promote the public health as part of the President's fiscal year (FY) 2013 budget – a 17 percent increase over the FDA enacted budget for FY 2012. Industry user fees would fund 98 percent of the proposed budget increase. The FY 2013 request covers the period from Oct. 1, 2012 through Sept 30, 2013.
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New Jersey company agrees to halt production of unapproved dental devices
Accurate Set Inc., of Newark, N.J., and the company’s president and owner, Cornell L. Adams, have agreed to stop manufacturing and distributing medical devices as part of a consent decree of permanent injunction.
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Medasys Inc. Announces FDA Approval for Implantable Programmable Drug Pump
MOUNT OLIVE, N.J., Feb. 13, 2012 /PRNewswire/ -- Medasys Inc., a medical device company focused on providing implantable drug delivery solutions, announced today that it has received PMA approval from the U. S. Food and Drug Administration (FDA) for its Prometra®...
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BYDUREON™, First and Only Once-Weekly Type 2 Diabetes Treatment, Now Available in U.S. Pharmacies
 SAN DIEGO and DUBLIN, Feb. 13, 2012 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced that BYDUREON™ (exenatide extended-release for injectable suspension) is now available by prescription in U.S. pharmacies....
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New Multicenter Study Seeking to Reduce the Devastating Impact of Sepsis Will Rely on Cheetah Medical's NICOM® Non-Invasive Technology
TEL-AVIV, Israel and VANCOUVER, Washington, February 13, 2012 /PRNewswire/ --
Cheetah Medical, a leader in non-invasive hemodynamic monitoring announced today the launch of a multicenter clinical study evaluating a novel, aggressive approach for management of sepsis. The study's goal is...
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Watson Confirms Beyaz(R) Patent Challenge
 PARSIPPANY, N.J., Feb. 10, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to...
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FDA investigating illegal online sale of handheld dental X-ray units
The U.S Food and Drug Administration is warning dental and veterinary professionals to not purchase or use certain potentially unsafe hand-held dental X-ray units. The FDA is concerned that these devices may not be safe or effective and could expose the user and the patient to unnecessary and potentially harmful X-rays. The units, sold online by manufacturers outside the United States and directly shipped to U.S. customers, have not been reviewed by the FDA and do not meet FDA radiation safety requirements. (MB)
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Insmed Incorporated Provides Update on Clinical Program for ARIKACE®
MONMOUTH JUNCTION, N.J., Feb. 10, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that the Company is proceeding with a phase 2 clinical trial of ARIKACE® (liposomal amikacin for inhalation) in patients with...
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FDA issues draft guidance on biosimilar product development
The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.
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FDA and industry reach agreement in principle on medical device user fees
The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.
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FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer
The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today's action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.
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FDA approves Kalydeco to treat rare form of cystic fibrosis
The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.
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FDA takes action against New York cheese manufacturer
The U.S. Food and Drug Administration is asking a federal court to prevent a New York cheese manufacturer from operating because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria.
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FDA approves new treatment for most common type of skin cancer
Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).
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FDA approves Inlyta to treat patients with a type of advanced kidney cancer
The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.
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Department of Justice files Consent Decree of Permanent injunction against Ranbaxy
Generic drug manufacturer agrees to remedy deviations from the current good manufacturing practice requirements and to correct data integrity problems at numerous facilities
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Maine company holds cold smoked salmon product after FDA order
A Maine food processing and storage company destroyed its cold smoked salmon product under the supervision of the U.S. Food and Drug Administration after inspectors found Listeria monocytogenes within the firm’s facility and on processing equipment
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FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri
Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD).
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FDA approves Voraxaze to treat patients with toxic methotrexate levels
The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.
Methotrexate is a commonly used cancer chemotherapy drug normally eliminated from the body by the kidneys. However, patients receiving high doses of methotrexate may develop kidney failure.
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FDA expands use of endovascular graft to treat aortic tears
The U.S. Food and Drug Administration today expanded the approved usage for an endovascular graft manufactured by W.L. Gore and Associates Inc. to include treatment of life-threatening tears or ruptures of the aorta (thoracic aortic transection). (MB)
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FDA completes work on three drug user fee programs
The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said today. The recommendations were transmitted to Congress today by Health and Human Services Secretary Kathleen Sebelius.
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