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FDA Approves Injectable Diabetes Drug from Glaxo

April 15, 2014 5:32 pm | by The Associated Press | News | Comments

The FDA has approved a new injectable drug from GlaxoSmithKline plc for adults with Type 2 diabetes. The agency cleared the company's drug, Tanzeum, to help patients control their blood sugar levels, in combination with diet and exercise.  

DNA Alternative to Pap Smear Sparks Medical Debate

April 15, 2014 1:41 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

A high-tech screening tool for cervical cancer is facing pushback from more than a dozen U.S....

FDA Approves Merck’s Allergy Treatment

April 15, 2014 8:04 am | News | Comments

Merck has announced that FDA has approved GRASTEK ® (Timothy Grass Pollen Allergen Extract)...

FDA Extends Market Exclusivity of KUVAN Powder for Oral Solution and Tablets

April 14, 2014 8:22 am | News | Comments

BioMarin Pharmaceutical today announced that the FDA granted KUVAN(R) (sapropterin...

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BMS Submits NDA for a Fixed-Dose Combination Tablet of Atazanavir Sulfate with Cobicistat for HIV-1

April 14, 2014 8:18 am | News | Comments

Bristol-Myers Squibb Company announced today the submission of a new drug application (NDA) on April 4, 2014 to the FDA for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz®, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective.

Congressional Report Presses for E-cigarette Rules

April 14, 2014 7:52 am | by MICHAEL FELBERBAUM, AP Tobacco Writer | News | Comments

Concerns about electronic cigarettes, including flavors and marketing that could appeal to young people, underscore the need to regulate the fast-growing industry, according to a Congressional report released Monday.      

FDA Approves Lipiodol Injection For Tumor Imaging

April 11, 2014 11:12 am | News | Comments

Guerbet announced that Lipiodol® was approved by the US Food and Drug Administration pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act indicated for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC). 

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FDA Places Clinical Hold on Halozyme’s PEGPH20 Pancreatic Cancer Trial

April 10, 2014 8:58 am | News | Comments

Halozyme Therapeutics, Inc. has announced that the  FDA has  informed the company that a clinical hold has been placed on patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer.

FDA Approves Pradaxa For Deep Vein Thrombosis & Pulmonary Embolism

April 8, 2014 11:44 am | by Associated Press | News | Comments

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa ® (dabigatran etexilate) for the treatment of DVT and PE in patients who have been treated with a parenteral (injectable) anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.

FDA Approves Handheld Opiate Antidote

April 4, 2014 8:53 am | Videos | Comments

One person dies every 36 minutes from an opioid overdose from painkillers. A recently approved drug aims to reverse that trend.                      

FDA Approves EVZIO for the Emergency Treatment of Opioid Overdose

April 3, 2014 11:01 am | News | Comments

Kaleo announced that the FDA has approved EVZIO (naloxone hydrochloride injection) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.      

FDA Accepts Biologic License Application for Fibrocaps Hemostatic Agent

April 3, 2014 8:00 am | News | Comments

The Medicines Company has announced that the FDA has accepted the filing of a biologic license application (BLA) for the investigational hemostatic agent Fibrocaps, a dry powder formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery, where control of mild or moderate bleeding by conventional means is ineffective or impractical.

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FDA OKs First Hay Fever Allergy Immunotherapy Tablet

April 2, 2014 11:28 am | by The Associated Press | News | Comments

The U.S. Food and Drug Administration has approved the first tablet for gradually reducing hay fever allergy symptoms, an alternative to uncomfortable allergy-desensitizing shots.            

FDA Fast Tracks IV and Oral Formulations of Eravacycline

April 2, 2014 8:43 am | News | Comments

Tetraphase Pharmaceuticals today announced that the FDA has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company’s lead antibiotic candidate, eravacycline.        

FDA Committee Recommends Approval of AFREZZA

April 2, 2014 8:16 am | News | Comments

MannKind Corporation announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 13 to 1 to recommend that AFREZZA® (insulin human [rDNA origin]) Inhalation Powder be granted marketing approval by the FDA.   

Beer Brewers in Uproar Over New Proposed FDA Rule

March 31, 2014 3:22 pm | News | Comments

A proposed federal rule that would make it harder for beer breweries to sell leftover grains as animal feed has brewers' blood boiling. Beer makers complain that the new rules, if adopted, would force them to dump millions of tons of "spent grains," which are left over after barley, wheat and other grains are steeped in hot water.

FDA Advisory Committee Recommends Approval of Cubist’s SIVEXTRO™

March 31, 2014 3:20 pm | News | Comments

Cubist Pharmaceuticals has announced today that the FDA Anti-Infective Drugs Advisory Committee (AIDAC) voted to recommend approval of Cubist’s investigational antibiotic SIVEXTRO™ (tedizolid phosphate).        

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FDA Approves Topamax for Migraine Prevention in Adolescents

March 31, 2014 8:42 am | News | Comments

The FDA has approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group.       

FDA Approves Biogen Idec’s ALPROLIX™

March 31, 2014 8:21 am | News | Comments

Biogen Idec has announced that the FDA has approved ALPROLIX™ [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body.      

Studies Find New Drugs Greatly Lower Cholesterol

March 29, 2014 3:31 pm | by Marilynn Marchione - AP Chief Medical Writer - Associated Press | News | Comments

A new class of experimental medicines can dramatically lower cholesterol, raising hopes of a fresh option for people who can't tolerate or don't get enough help from Lipitor and other statin drugs that have been in use for decades.  

Judge Won't Dismiss 'Pink Slime' Defamation Suit

March 28, 2014 8:35 am | News | Comments

A South Dakota judge on Thursday refused to throw out a defamation lawsuit against ABC related to its coverage of a meat product called lean, finely textured beef, which critics have dubbed "pink slime."        

Twenty-Five Companies to Phase Out Animal Antibiotics

March 27, 2014 8:34 am | by MARY CLARE JALONICK, Associated Press | News | Comments

Twenty-five pharmaceutical companies are voluntarily phasing out the use of antibiotics for growth promotion in animals processed for meat, the Food and Drug Administration said Wednesday.           

Under Fire, Zohydro Maker Touts Drug Safety Board

March 26, 2014 1:33 pm | by Matthew Perrone - AP Health Writer - Associated Press | News | Comments

After months of criticism over its recently launched painkiller Zohydro, the maker of the powerful narcotic is highlighting an unusual oversight board that it's assembled to try and prevent abuse of the drug.       

"The Race to Yes" Hits Major Milestone

March 26, 2014 10:05 am | by Associated Press | News | Comments

The Race to Yes, a national campaign by families with children facing death from Duchenne Muscular Dystrophy achieved an important milestone just after 8pm EDT last night when the 100,000th person signed their White House petition urging the U.S. Food and Drug Administration to approve a breakthrough drug shown to halt the progress of the disease.

FDA Takes Heat on Slow Review for More Powerful Sunscreens

March 24, 2014 8:48 am | Videos | Comments

Dermatologists and skin care advocates are frustrated with little to no advances in approval for better sunscreens.                       

FDA Sets Date for Moxduo Advisory Committee Meeting

March 24, 2014 8:32 am | News | Comments

QRxPharma Limited announced today the United States Food and Drug Administration (FDA) has set 22 April 22, 2014 as the date of the Advisory Committee meeting to consider the company's resubmitted Moxduo New Drug Application (NDA).   

FDA Approves Xolair for Chronic Idiopathic Urticaria

March 24, 2014 8:25 am | News | Comments

The FDA has approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives. The new use is for patients 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy.

Dust Off That Tinfoil Hat: Vaccinations

March 21, 2014 5:23 pm | by Nikita Ernst, Associate Editor | Blogs | Comments

The controversy over vaccinations is back in the spotlight, after a Colorado bill passed tightening the loophole that allows parents to choose not to vaccinate, and actress Kristen Cavalarri spoke out against vaccinations claiming a connection with autism. What's more frightening is the frequency of outbreaks of diseases we thought we'd eradicated. 

South Carolina Bill Allowing Limited Use of Cannabis Oil Advances

March 21, 2014 8:02 am | by SEANNA ADCOX, Associated Press | News | Comments

A bill that seeks to allow children with severe epilepsy to legally use oil derived from marijuana advanced Thursday to the South Carolina Senate floor, but with so many restrictions, supporters say it won't help those for whom it's written.

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