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Hovione’s Cork, Ireland API Plant Passes FDA Pre- Approval Inspection

July 31, 2014 1:26 pm | News | Comments

The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued.              

FDA Takes Steps to Ensure the Reliability of Certain Diagnostic Tests

July 31, 2014 12:37 pm | News | Comments

The U.S. Food and Drug Administration has taken important steps to ensure that certain tests...

Israel's Ministry of Health Approves Pluristem's Commercial-Scale 3D Cell Manufacturing Process

July 31, 2014 10:58 am | News | Comments

Pluristem Therapeutics has announced that it has completed the approval process and received...

Regeneron and Sanofi to Use Priority Review Voucher For Alirocumab Submission

July 31, 2014 10:27 am | News | Comments

Regeneron Pharmaceuticals and Sanofi announced that the companies intend to use an FDA rare...

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FDA Approves EYLEA Injection for the Treatment of Diabetic Macular Edema

July 30, 2014 8:03 am | News | Comments

Regeneron Pharmaceuticals announced that the FDA has approved EYLEA Injection for the treatment of Diabetic Macular Edema (DME). The recommended dosage of EYLEA in patients with DME is 2 milligrams every two months after five initial monthly injections.

Impax Labs Shares Slump after FDA Inspection

July 29, 2014 3:59 pm | News | Comments

Shares of Impax Labs sank Tuesday after an FDA inspection uncovered potential problems at a facility where the company will make its experimental Parkinson's disease drug Rytary.            

FDA Inspects Impax's Taiwan Facility – Finds Ten Issues

July 29, 2014 8:11 am | News | Comments

Impax Laboratories announced that the FDA performed a general GMP  inspection and a Pre-Approval Inspection for RYTARY at the company's Taiwan manufacturing facility from July 21 to July 26, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations.

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FDA Grants Full Approval for IMBRUVICA for Two Indications

July 28, 2014 2:39 pm | News | Comments

Pharmacyclics, Inc. announced that the FDA has granted IMBRUVICA regular (full) approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated del 17p CLL patients.

FDA Approves Aqua Pharmaceuticals' ACTICLATE™ Tablets

July 28, 2014 9:11 am | News | Comments

ACTICLATE™ is a tetracycline-class antibacterial indicated for the treatment of a number of infections, including adjunctive therapy in severe acne.                 

Ruling on Antibiotics in Livestock Reversed

July 25, 2014 8:36 am | News | Comments

The U.S. Food and Drug Administration isn't required to hold public hearings to evaluate the health risks of widespread use of antibiotics in animal feed, a federal appeals court ruled Thursday.         

FDA Reviewing What Could Be First Biosimilar Drug

July 24, 2014 3:51 pm | News | Comments

Five years after Congress passed a law allowing biosimilars, for the first time the FDA has accepted an application to sell a similar, but not identical, version of a biologic drug.            

FDA Approves New Extended-Release Oxycodone with Abuse-Deterrent Properties

July 24, 2014 7:59 am | News | Comments

The FDA has approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

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FDA Warns of Compounded Drug Recall by Texas Firm

July 23, 2014 3:38 pm | News | Comments

The agency says FDA inspectors recently uncovered unsanitary conditions at Unique Pharmaceuticals' plant in Temple, Texas. The inspections revealed production problems in several lots of drugs that were supposed to be sterile.    

FDA Approves Gilead Sciences Drug for Three Cancers

July 23, 2014 1:07 pm | News | Comments

Regulators approved the drug for patients with forms of chronic lymphocytic leukemia, follicular lymphoma and small lymphocytic lymphoma. The cancers affect an estimated 200,000 patients in the U.S., according to Gilead. The company's tablet, Zydelig, works by blocking signals inside some cancer cells that allow them to grow and survive.

FDA Designates Dompe’s rhNGF-Based Treatment for Neurotrophic Keratitis Orphan Drug Status

July 23, 2014 8:25 am | News | Comments

The candidate drug, developed by the research of Dompe, has been designated as an orphan drug for the treatment of neurotrophic keratitis, a degenerative corneal disease that affects less than 1 in 5,000 people and is currently without a cure.

FDA Approves Eagle Pharmaceuticals’ Ryanodex®

July 23, 2014 8:09 am | News | Comments

Eagle Pharmaceuticals today announced that the FDA has approved Ryanodex® (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures.    

FDA Warns About Dangers of Caffeine Powder

July 22, 2014 9:10 am | Videos | Comments

The medical alert came after an Ohio teen died from a caffeine overdose days before his high school graduation.                       

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Sanofi Pasteur Begins Shipping Seasonal Influenza Vaccine for Upcoming 2014-2015 Season in United States

July 22, 2014 9:04 am | News | Comments

Sanofi Pasteur, the vaccines division of Sanofi, announced today that the first lots of Fluzone (Influenza Vaccine) for the 2014-2015 influenza season have been released by the U.S. Food and Drug Administration (FDA) for distribution.   

Judge: FDA Can't Use Tobacco Panel Menthol Report

July 22, 2014 8:32 am | by MICHAEL FELBERBAUM, AP Tobacco Writer | News | Comments

The FDA can't use an advisory panel's 2011 report on menthol cigarettes because its members had conflicts of interest, a federal judge ruled Monday. While the agency has since conducted an independent review on the public health impact of menthol cigarettes, the ruling could hinder the FDA's ability to defend any future regulation of the minty smokes.

FDA Grants Genentech’s Avastin Priority Review for Recurrent Platinum-Resistant Ovarian Cancer

July 22, 2014 8:13 am | News | Comments

Genentech, a member of the Roche Group, today announced that the FDA has accepted the company's supplemental Biologics License Application and granted Priority Review for Avastin® plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.

OpenFDA – the Good, the Bad, and the Ugly

July 21, 2014 3:39 pm | by Brian Overstreet, CEO, AdverseEvents | Blogs | Comments

In an ideal world, OpenFDA could usher in a world of new and improved tools and products that would improve patient safety and adherence, increase physician awareness of drug safety dangers, assist healthcare decision makers who are driving prescribing behavior with better decision support, and lower the overall cost of care by reducing avoidable side effects. But we don’t live in an ideal world.

Teen's Death Puts Focus on Caffeine Powder Dangers

July 21, 2014 8:56 am | by ANN SANNER, Associated Press | News | Comments

The  Food and Drug Administration said Friday that it's investigating caffeine powder and will consider taking regulatory action. The agency cautioned parents that young people could be drawn to it. Caffeine powder is sold as a dietary supplement, so it's not subject to the same federal regulations as certain caffeinated foods.

States Sue 5-Hour Energy Over Ad Claims

July 21, 2014 8:35 am | by STEVEN DUBOIS, Associated Press | News | Comments

The Oregon lawsuit filed Thursday in Portland contends 5-Hour Energy falsely claims customers get extra energy and focus from a unique blend of ingredients, when the boost actually comes from a concentrated dose of caffeine.     

Aduro BioTech Receives FDA Breakthrough Therapy Designation for Innovative Pancreatic Cancer Combination Immunotherapy

July 21, 2014 8:28 am | News | Comments

Aduro BioTech, Inc., a clinical-stage biotechnology company, today announced that the FDA has granted Breakthrough Therapy Designation for its pancreatic cancer combination treatment that consists of its CRS-207 and GVAX Pancreas immunotherapies.

Regulus Receives FDA Orphan Drug Designation for RG-012, a microRNA Therapeutic for the Treatment of Alport Syndrome

July 21, 2014 8:07 am | News | Comments

Regulus Therapeutics Inc., announced today that the FDA has granted orphan drug designation to RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21, as a therapeutic for the treatment of Alport syndrome, a life-threatening genetic kidney disease with no approved therapy.

FDA Approves New Product to Treat Rare Genetic Disease

July 17, 2014 10:22 am | News | Comments

The FDA has approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).           

300 Vials Labeled Influenza, Dengue Found at Lab

July 17, 2014 8:26 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

FDA officials said Wednesday the undocumented collection contained 327 carefully packaged vials, listing pathogens like dengue, influenza and rickettsia. Last week the government only disclosed that it had recovered six glass vials of smallpox dating from the 1950s.        

FDA Issues Draft Information Sheet Guidance on Informed Consent

July 16, 2014 11:42 am | News | Comments

This draft guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent.      

FDA Approves Purdue Pharma’s 7.5 mcg/hour Dosage Strength of Butrans

July 16, 2014 8:31 am | News | Comments

Purdue Pharma announced that the FDA has approved a new 7.5 mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans will now be available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour and 20 mcg/hour.

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