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Alcon's Xtoro Approved to Treat Swimmer’s Ear

December 17, 2014 4:17 pm | News | Comments

The FDA has approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear. Acute otitis externa is an infection in the outer ear and ear canal, usually caused by bacteria in the ear canal.

FDA Approves Pathogen Reduction System to Treat Plasma

December 17, 2014 10:24 am | News | Comments

The FDA has approved the Intercept Blood System for plasma, the first pathogen reduction system...

FDA Approves Ipsen's Somatuline® Depot® Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors

December 17, 2014 8:23 am | News | Comments

Ipsen Biopharmaceuticals announced that Somatuline® Depot® Injection 120 mg (referred to as...

FDA Approves Novartis’ Signifor for Acromegaly

December 16, 2014 8:12 am | News | Comments

Acromegaly is a rare, debilitating endocrine disorder caused by the excess production of growth...

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Baxter Recalls Two Lots of Sodium Chloride Injection

December 15, 2014 3:10 pm | News | Comments

Baxter announced it voluntarily initiated a recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container to the hospital/user level. The recall is being initiated as a result of two complaints (one per lot) of particulate matter that was identified as a fragment of the frangible from the vial adapter.

Crunch Time Again for Health Insurance Sign-Ups

December 15, 2014 8:51 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

President Barack Obama's push to cover America's uninsured faces another big test today. This time, it's not only how the website functions, but how well the program itself works for millions who are starting to count on it.     

FDA Approves Sanofi Pasteur’s Fluzone Vaccine

December 15, 2014 8:30 am | News | Comments

Sanofi Pasteur, the vaccines division of Sanofi, has announced that the FDA has approved the supplemental biologics license application for Fluzone Intradermal Quadrivalent vaccine. Fluzone Intradermal vaccine, which has been available in trivalent formulation for three years, is now available in a quadrivalent formulation to help protect against four strains of influenza virus.

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Lilly's Cyramza Gets New Marketing Approval

December 15, 2014 8:12 am | News | Comments

The Food and Drug Administration is allowing Lilly to market the drug as a treatment for cases that have spread. Earlier this year the FDA approved the drug as a treatment for gastric cancer.          

FDA Approves Test to Confirm Presence of Human T-cell Lymphotropic Virus-I/II Antibodies

December 11, 2014 1:53 pm | News | Comments

The FDA has approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II). This test is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on an FDA-licensed HTLV-I/II blood donor screening test.

Health Law Sign-Ups Pick Up

December 11, 2014 10:58 am | News | Comments

The Obama administration says sign-ups picked up last week under the president's health care law. More than 618,000 people selected a plan for 2015 from Nov. 29 through Dec. 5, the Health and Human Services department reported.    

FDA OKs Gardasil 9 to Prevent Cancers Caused by Five Additional Types of HPV

December 10, 2014 3:27 pm | News | Comments

The FDA has approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil, Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.

Lawmakers Wary of Genetically Modified Food Labels

December 10, 2014 2:06 pm | by MARY CLARE JALONICK, Associated Press | News | Comments

Republicans and Democrats on a House Energy and Commerce subcommittee questioned Wednesday whether requiring a label on any packaged food including genetically modified organisms — or foods grown from seeds engineered in labs — would be misleading to consumers since there is no evidence that such foods are unsafe.

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FDA Approves Amgen's XGEVA

December 8, 2014 10:40 am | News | Comments

Amgen announced that the FDA has approved a new indication for XGEVA (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy. XGEVA was approved and granted Orphan Drug Designation by the FDA.  

FDA Approves Labeling Update of Abilify Maintena®

December 8, 2014 8:30 am | News | Comments

Otsuka Pharmaceutical and H. Lundbeck A/S announced that FDA approved the labeling update of Abilify Maintena® for extended-release injectable suspension. The approval was based on results from a controlled clinical study of acutely relapsed adults with schizophrenia.

E-Cigarette Tech Takes Off as Regulation Looms

December 8, 2014 7:58 am | by MICHAEL FELBERBAUM, AP Tobacco Writer | News | Comments

Just a few years ago, early adopters of e-cigarettes got their fix by clumsily screwing together a small battery and a plastic cartridge containing cotton soaked with nicotine. Now, the battery-powered contraptions have computer chips to regulate puffs and temperature, track usage, talk to other electronic devices and even blink when "vapers" are near each other.

HealthCare.gov Average Premiums Going Up in 2015

December 4, 2014 1:12 pm | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

Many HealthCare.gov customers will face higher costs next year, the Obama administration acknowledged in a report that shows average premiums rising modestly. However, officials said millions of consumers who are currently enrolled can mitigate the financial consequences if they are willing to shop around for another plan in a marketplace that's becoming more competitive.

FDA Approves Jakafi for Patients with Uncontrolled Polycythemia Vera

December 4, 2014 11:21 am | News | Comments

Incyte Corporation announced that the FDA has approved Jakafi® for the treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi, an oral medication, is the first and only product approved by the FDA for PV, a rare and progressive blood cancer.

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Advocates Urge Swift Senate Vote on Disability Aid

December 4, 2014 8:14 am | by HOPE YEN, Associated Press | News | Comments

Supporters of legislation that would allow Americans with disabilities to open tax-free savings accounts to pay for long-term expenses are urging a swift vote in the Senate after the House overwhelmingly passed the bill.     

FDA Approves Blincyto for Rare Form of Acute Lymphoblastic Leukemia

December 3, 2014 3:09 pm | News | Comments

The U.S. Food and Drug Administration has approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.      

FDA Issues Final Rule on Changes to Pregnancy and Lactation Labeling Info for Rx Drug and Biological Products

December 3, 2014 11:43 am | News | Comments

The FDA published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.

FDA Wary of Lifting Gay Blood Donor Ban

December 3, 2014 8:26 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

Government health advisers have concerns about lifting a nationwide ban on blood donations from gay and bisexual men, despite growing pressure from gay rights advocates, medical experts and blood banks.         

FDA Approves Priftin Tablets for the Treatment of Latent Tuberculosis Infection

December 2, 2014 9:08 am | News | Comments

Sanofi announced today that following a priority review, the FDA has approved Priftin in combination with isoniazid for a new indication for the treatment of latent tuberculosis infection in patients two years of age and older at high risk of progression to tuberculosis disease.

Facing Health Law Hikes, Consumers Mull Options

November 25, 2014 1:34 pm | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

Consumers across most of America will see their health insurance premiums go up next year for popular plans under President Barack Obama's health care law.                

FDA Approves Valeant’s ONEXTON Acne Gel

November 25, 2014 8:13 am | News | Comments

Valeant Pharmaceuticals has received approval from the FDA for ONEXTON Gel (clindamycin phosphate and benzoyl peroxide), 1.2%/3.75%, for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne in patients 12 and older.  

Aurobindo Pharma Recalls Northstar Label Gabapentin Capsules, USP 300 mg Due to Complaints of Empty Capsules

November 24, 2014 3:04 pm | News | Comments

Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.         

FDA Issues Additional Guidance for Outsourcing Facilities That Compound Sterile Human Drugs

November 24, 2014 1:18 pm | News | Comments

The FDA has issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the DQSA, which was enacted in November 2013.

FDA Approves Hard-to-Abuse Hydrocodone Pill

November 20, 2014 3:27 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal health regulators have approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking such safeguards.       

Report: Sub-Standard Medicine Floods Afghan Market

November 19, 2014 8:08 am | News | Comments

Half of all medicine available on the Afghan market has either been smuggled into the country or made under sub-standard conditions in neighboring Pakistan, according to a report released on Wednesday.        

Administration Says HealthCare.gov Working Well

November 18, 2014 9:07 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

As a crucial second sign-up season gears up, the Obama administration said Sunday that HealthCare.gov is stable and working well, a far cry from last year's frozen computer screens and frustrated customers.          

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