Drug Approvals

Welcome to the 'Drug Approvals' tag page at Technorati. This page features content from the farthest reaches of the Blogosphere that authors have "tagged" with 'Drug Approvals'.

Latest blogosphere posts tagged “Drug Approvals”

• New Type 2 Diabetes And Obesity Treatment Approved - EndoBarrier Receives European CE Mark

  
  Pharmainfo.net — Authority: 172
  GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced that it has received European CE mark approval for the EndoBarrier™, a non-surgical therapy to treat type 2 diabetes and obesity. The CE marking (an acronym for the French "Conformite Europeenne") certifies ...
  3 days ago

• Alexza Announces Submission Of AZ-004 (Staccato(R) Loxapine) NDA

  
  Pharmainfo.net — Authority: 172
  Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced that it has submitted its New Drug Application (NDA) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration ( FDA ). AZ-004 is an inhalation product candidate being developed for the rapid treatment of agitation in patients with schizophrenia or ...
  1 week ago

• Jazz Pharmaceuticals Submits New Drug Application For JZP-6 (sodium Oxybate) For The Treatment Of Fibromyalgia

  
  Pharmainfo.net — Authority: 172
  Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia. The submission is based on a comprehensive clinical development program for JZP-6, including results ...
  1 week ago

• FDA Takes Further Steps To Set Clear Guidelines For PET Radiopharmaceuticals

  
  Health News from Medical News Today — Authority: 713
  The U.S. Food and Drug Administration (FDA) announced publication of a final regulation on current good manufacturing practices (cGMPs) for the production of positron emission tomography (PET) drugs, as well as a guidance document describing acceptable approaches that would enable PET drug producers to meet the ...
  2 weeks ago

• Law To Ban BPA In Childrens Products Announced By US Senators

  
  Health News from Medical News Today — Authority: 713
  Two New York Senators announced new legislation to ban the plastics chemical Bisphenol A (BPA) from products commonly used by children and pregnant women; the news comes in the wake of a recent study by Consumer Reports that showed BPA is now used to make a much larger range of products, and in higher ...
  2 weeks ago

• FDA Debars Convicted Virginia Seafood Dealer From Importing Food For 20 Years

  
  Pharmainfo.net — Authority: 172
  A Virginia man sentenced to five years in prison for his role in a conspiracy to import catfish from Vietnam for fraudulent sale to avoid paying federal import tariffs has been barred from importing articles of food or offering such articles for import into the United States for the next 20 years, the U.S. Food and ...
  2 weeks ago

• Amneal Receives FDA Approval For Nizatidine Oral Solution, The First Generic Oral Solution For Axid(R) In The Market

  
  Pharmainfo.net — Authority: 172
  Amneal Pharmaceuticals is pleased to announce that it has received U.S. FDA approval to manufacture Nizatidine Oral Solution in the 15 mg/mL strength effective November 18, 2009. It is an AA-rated, therapeutically equivalent alternative to Axid® Oral Solution (a licensed trademark of Braintree Labs)... ...
  2 weeks ago

• American Pain Society Endorses FDA Guideline For Medication Disposal

  
  Pharmainfo.net — Authority: 172
  Calling it "an important first step in attempting to reverse an escalating public health menace caused by diversion of prescription opioid pain medications," the American Pain Society today announced its support for a new FDA initiative to encourage consumers to remove unused pain drugs from home medicine ...
  3 weeks ago

• European Medicines Agency Publishes First Weekly Pandemic Pharmacovigilance Update

  
  Pharmainfo.net — Authority: 172
  The European Medicines Agency has published today the first in a series of weekly pandemic pharmacovigilance updates... Advertisement: read more
  3 weeks ago

• AACR Takes Steps To Aid The FDA In Regulating Tobacco; Publishes Best Research Practices

  
  Pharmainfo.net — Authority: 172
  When President Barack Obama signed the Family Smoking Prevention and Control Act in June, he ushered in a new era of tobacco policy that empowers the Food and Drug Administration to regulate one of the worlds most controversial and deadly consumer products... Advertisement: read more
  3 weeks ago

• Axxonis Pharma AG Withdraws Its Marketing Authorisation Application For Nenad (lisuride), Europe

  
  Pharmainfo.net — Authority: 172
  The European Medicines Agency has been formally notified by Axxonis Pharma AG of its decision to withdraw its application for a centralised marketing authorisation for the medicine Nenad (lisuride), 2.5 and 5.0 microgram/h transdermal patch. Nenad was expected to be used in adults with moderate-to-severe idiopathic ...
  3 weeks ago

• Human Genome Sciences Submits Biologics License Application To FDA For ZALBIN™

  
  Pharmainfo.net — Authority: 172
  Human Genome Sciences, Inc. (Nasdaq: HGSI) announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration ( FDA ) for ZALBIN™ (albinterferon alfa-2b) for the treatment of chronic hepatitis C. Advertisement: read more
  4 weeks ago

• FDA Approves Agriflu Seasonal Influenza Vaccine

  
  Pharmainfo.net — Authority: 172
  The U.S. Food and Drug Administration approved Agriflu for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B. Advertisement: read more
  4 weeks ago

• U.S. Food And Drug Administration Approves ABILIFY® (aripiprazole) For The Treatment Of Irritability Associated With Autistic Disorder In Patients

  
  Pharmainfo.net — Authority: 172
  (BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced that the U.S. Advertisement: read more
  4 weeks ago

• Merck KGaA: CHMP Opinion For Erbitux In Advanced Non-Small Cell Lung Cancer

  
  Pharmainfo.net — Authority: 172
  The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has adopted a negative opinion for the use of Erbitux® (cetuximab) in combination with platinum-based chemotherapy for the treatment of patients with epidermal growth factor receptor ...
  5 weeks ago

• AstraZeneca Submits US New Drug Application For Brilinta (Ticagrelor), An Investigational Antiplatelet Agent

  
  Pharmainfo.net — Authority: 172
  AstraZeneca announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration ( FDA ) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is ...
  5 weeks ago

• Sitagliptin Approved As Add-on To Insulin

  
  Pharmainfo.net — Authority: 172
  Sitagliptin (known as Januvia) has been approved by the European Commission as an add-on to insulin (with or without metformin) for people with Type 2 diabetes who cannot control their condition effectively with a combination of diet, physical activity and insulin. Advertisement: read more
  5 weeks ago

• European Medicines Agency Makes Recommendations To Minimise Risk Of Nephrogenic Systemic Fibrosis With Gadolinium-containing Contrast Agents

  
  Pharmainfo.net — Authority: 172
  The European Medicines Agency (EMEA) has adopted a set of recommendations aimed at minimising the risk of nephrogenic systemic fibrosis (NSF) with gadolinium-containing contrast agents in patients at risk of developing the condition. Gadolinium-containing contrast agents are used in patients undergoing magnetic ...
  5 weeks ago

• ICT Fails To Accelerate Drug Approvals

  
  Health News from Medical News Today — Authority: 713
  Drug approvals are taking just as long as they ever did despite increased expenditure on new information technology at the Food and drug Administration. So says a statistical analysis of approval intervals from 1997 to 2006, published in the International Journal of Electronic Healthcare.
  5 weeks ago

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