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FDA to Scrutinize Unproven Alternative Remedies

March 26, 2015 3:23 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal officials plan to review the safety and evidence behind alternative remedies like Zicam and Cold-Eeze, products that are protected by federal law, but not accepted by mainstream medicine.

Orexigen's Mysimba Approved in Europe for the Treatment of Obesity

March 26, 2015 3:17 pm | News | Comments

Orexigen Therapeutics has announced that the European Commission has granted marketing...

Science, Patients Driving Rare Disease Drug Research Surge

March 25, 2015 2:24 pm | by LINDA A. JOHNSON, AP Business Writer | News | Comments

The global pharmaceutical industry is pouring billions of dollars into developing treatments for...

FDA Approves Sanofi Pasteur’s Quadracel DTaP-IPV Vaccine for Children

March 25, 2015 12:24 pm | News | Comments

Sanofi Pasteur, the vaccines division of Sanofi announced that FDAhas approved use of Quadracel...

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Emergent BioSolutions Receives FDA Approval for Anthrasil

March 25, 2015 11:40 am | News | Comments

Emergent BioSolutions has announced that the FDA has approved Anthrasil™ [Anthrax Immune Globulin Intravenous (Human)], also known as AIGIV, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs.

FDA Approves New Treatment for Diabetic Retinopathy in Patients with Diabetic Macular Edema

March 25, 2015 11:31 am | News | Comments

The FDA has expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema.

CDC: Uninsured Drop by 11M Since Passage of Obama's Law

March 25, 2015 8:24 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

The number of uninsured U.S. residents fell by more than 11 million since President Barack Obama signed the health care overhaul five years ago, according to a pair of reports Tuesday from the federal Centers for Disease Control and Prevention.

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FDA Warns Cosmetics Companies Against Promises That 'Go Too Far'

March 24, 2015 8:04 am | by Andy Szal, Digital Reporter | News | Comments

The agency said its tracking of claims by cosmetics companies during recent years indicated a proliferation in drugs claims--defined by the FDA as "intended to treat or prevent disease, or change the body’s structure or functions"--on product packaging and in web advertising.

WHO Denies Politics Swayed Ebola Emergency Declaration

March 23, 2015 4:14 pm | by MARIA CHENG, Associated Press; RAPHAEL SATTER, Associated Press | News | Comments

The World Health Organization denied that politics swayed the decision to declare an international emergency over the spread of the Ebola virus last year, despite evidence senior staffers repeatedly discussed the diplomatic and economic fallout of such a move.

FDA Panel Backs Glaxo Inhaler for Adults, Not Adolescents

March 20, 2015 8:39 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

Government health advisers say a once-a-day respiratory inhaler from GlaxoSmithKline appears safe and effective for adults with asthma, but not for adolescents.

Emails: World Health Organization Resisted Declaring Ebola Emergency

March 20, 2015 8:20 am | by MARIA CHENG, Associated Press; RAPHAEL SATTER, Associated Press | News | Comments

In a delay that some say may have cost lives, the World Health Organization resisted calling the Ebola outbreak in West Africa a public health emergency until last summer, two months after staff raised the possibility and long after a senior manager called for a drastic change in strategy.

Vertex Gets FDA Approval of KALYDECO® for Children with Cystic Fibrosis

March 18, 2015 3:54 pm | News | Comments

Vertex Pharmaceuticals has announced that the FDA approved KALYDECO® for use in children ages 2 to 5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator ( CFTR) gene.

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Xcelience Receives DEA Approval to Develop and Manufacture DEA Schedule I Drug Products

March 17, 2015 2:56 pm | News | Comments

Xcelience has received approval from the Federal Drug Enforcement AdminIstration to develop and manufacture Schedule I controlled substances in their facilities. Schedule I substances are "considered the most dangerous class of drugs," according to the DEA website. 

American Who Contracted Ebola Now in Critical Condition

March 17, 2015 8:21 am | by BRETT ZONGKER, Associated Press | News | Comments

An American health care worker who contracted Ebola while volunteering in a Sierra Leone treatment unit has been downgraded to critical condition at the National Institutes of Health, doctors said Monday.

Actavis Receives FDA Approval for VIIBRYD

March 17, 2015 8:10 am | News | Comments

Actavis announced that the FDA has approved a lower therapeutic dose of VIIBRYD (vilazodone HCl) (20mg) to accompany the 40 mg daily therapeutic dose.

EPA, FDA Sign Data Sharing Agreement

March 17, 2015 7:56 am | by Andy Szal, Digital Reporter | News | Comments

The Environmental Protection Agency and the Food and Drug Administration signed an agreement to share data relating to pesticides and toxic substances, the agencies announced Monday.

Louisiana Germ Release Likely Due to Lax Use of Lab Garments

March 16, 2015 8:23 am | by MIKE STOBBE, AP Medical Writer | News | Comments

The accidental release of dangerous bacteria at a Louisiana research center probably occurred because workers were lax about how they wore protective garments in the lab where the germ was kept, federal officials said Friday.

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Merck's Sugammadex Dealt Another Setback

March 16, 2015 8:06 am | News | Comments

The company said Friday that the Food and Drug Administration has canceled a March 18 meeting to review sugammadex, which is designed to help patients "wake up" after surgical anesthesia.

Hospira Issues a Voluntary Nationwide Recall of One Lot of Lactated Ringer's Irrigation Due to Mold Contamination

March 13, 2015 8:40 am | News | Comments

Hospira is initiating a voluntary recall of one lot of Lactated Ringer's Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report of several dark, fibrous particulates floating within the solution of the primary container.

American Who Contracted Ebola Arrives at Maryland Hospital

March 13, 2015 8:22 am | News | Comments

An American healthcare worker who contracted Ebola while volunteering in a Sierra Leone treatment unit arrived safely at the National Institutes of Health's hospital in Maryland, officials announced early Friday.

FDA Approves Actavis’ SAPHRIS

March 13, 2015 8:15 am | News | Comments

Actavis announced that the FDA has approved its supplemental new drug application (sNDA) for SAPHRIS (asenapine) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10 - 17).

RetroVirox Awarded $3M NIH Grant to Develop Drugs to Cure HIV Infection

March 12, 2015 8:16 am | News | Comments

RetroVirox, Inc. a biotechnology company focused on viral diseases, announced today it has received a $3.0 million grant from the National Institutes of Health to develop immunomodulators to eradicate HIV infection with "shock and kill" therapies.

WHO Creates Independent Panel to Assess its Ebola Response

March 11, 2015 8:33 am | News | Comments

The World Health Organization says it has created a panel of independent experts to assess its response to the biggest-ever Ebola outbreak in history.

Complaint: Drugstores Fail to Disclose Countries of Origin on Prescriptions

March 10, 2015 2:05 pm | by Andy Szal, Digital Reporter | News | Comments

The Made in the USA Foundation announced a complaint filed with the U.S. Food and Drug Administration that accused large drugstore chains of failing to provide the country of origin on prescription drug labels.

Food Groups Call on Congress to Reject Fees in Obama Budget

March 10, 2015 8:52 am | by Andy Szal, Digital Reporter | News | Comments

In a letter to House and Senate appropriations committee leadership, the groups instead sought additional funding for the U.S. Food and Drug Administration, a move they said would reflect food safety's status as "a top national priority."

Report: Rural Hospitals Get Billions in Extra Medicare Funds

March 9, 2015 8:36 am | by MATT SEDENSKY, Associated Press | News | Comments

A law that allows rural hospitals to bill Medicare for rehabilitation services for seniors at higher rates than nursing homes and other facilities has led to billions of dollars in extra government spending, federal investigators say.

Made-in-Canada Ebola Vaccine Being Put to the Test in Three West African Studies

March 9, 2015 8:19 am | by Helen Branswell, The Canadian Press | News | Comments

For years scientists at Canada's National Microbiology Laboratory struggled to figure out how to test whether a vaccine developed at the Winnipeg lab would prevent people from contracting Ebola. Now, finally, three studies in West Africa may provide that answer.

Four Members of FDA Tobacco Panel Leave After Court Ruling

March 9, 2015 8:15 am | by MICHAEL FELBERBAUM, AP Tobacco Writer | News | Comments

Four members of Food and Drug Administration's tobacco advisory panel, including its chairman, have left after a federal judge ruled some of its members had conflicts of interest, the agency said.

FDA Approves First Biosimilar

March 9, 2015 8:12 am | by MATTHEW PERRONE, AP Business Writer; LINDA A. JOHNSON, AP Business Writer | News | Comments

Government health officials on Friday approved the first lower-cost copy of a biotech drug in the U.S., a long-awaited milestone that could save billions for insurers, doctors and patients.

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