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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-...

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...

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...

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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.

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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.        

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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.

FDA Grants Medivir's OLYSIO Priority Review

July 15, 2014 11:15 am | News | Comments

Medivir AB announced that the FDA has assigned a Priority Review designation to the supplemental New Drug Application for the use of once-daily Olysio (simeprevir) in combination with sofosbuvir for 12 weeks treatment of adult patients with genotype 1 chronic hepatitis C.

FDA Designates Opioid Overdose Treatment for Fast Track Development Program

July 15, 2014 11:09 am | News | Comments

A Kentucky company headed by a recognized expert in nasal delivery of medication says its intranasal naloxone spray, a drug designed to treat opioid overdoses, has received Fast Track designation from the Food and Drug Administration (FDA).  

FDA Grants Roche’s Avastin Priority Review for Certain Types of Cervical Cancer

July 15, 2014 8:38 am | News | Comments

Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.

FDA Weighs Cancer Risk of Fibroid Removal Devices

July 14, 2014 8:56 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal health advisers say there is little to no evidence that a popular technique for removing fibroids can be performed without the risk of spreading undetected cancers to other parts of the body.         

QRxPharma Provides Feedback on End-of-Review Meeting With the FDA on Moxduo

July 11, 2014 9:07 am | News | Comments

QRxPharma Limited today provided feedback on its July 9th End-of-Review (EOR) meeting with the United States Food and Drug Administration (FDA). The meeting was held to discuss the feasibility and requirements for approving Moxduo.   

Study: Psychiatric Drug ER Trips Approach 90,000 a Year

July 10, 2014 8:17 am | by LINDSEY TANNER, AP Medical Writer | News | Comments

Bad reactions to psychiatric drugs result in nearly 90,000 emergency room visits each year by U.S. adults, with anti-anxiety medicines and sedatives among the most common culprits, a study suggests.         

Bristol-Myers Squibb Makes Plans to Submit Biologics License Application for Opdivo®

July 10, 2014 8:12 am | News | Comments

Bristol-Myers Squibb Company today announced that, following discussions with the FDA, the company is planning a third quarter submission of a Biologics Licensing Application (BLA) for Opdivo® (nivolumab) for previously treated advanced melanoma.

Review of ADHD Drug Approvals Highlights Gaps between Pediatric Approval Process and Long-Term Safety Assessment

July 9, 2014 2:14 pm | News | Comments

Over the last 60 years, the FDA approved 20 medications for attention deficit/hyperactivity disorder (ADHD) based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events, researchers at Boston Children's Hospital report today in PLOS ONE.

Are Spray-On Sunscreens Safe for Kids?

July 9, 2014 12:04 pm | Videos | Comments

Consumer Reports advises parents to avoid spray sunscreens for their kids while the FDA investigates potential risks.                      

Forgotten Vials of Smallpox Found in Storage Room

July 8, 2014 2:04 pm | by MIKE STOBBE, AP Medical Writer | News | Comments

Government workers cleaning out an old storage room at a research center near Washington made a startling discovery last week — decades-old vials of smallpox packed away and forgotten in a cardboard box.        

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