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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.

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...

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...

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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.

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.

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.

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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.

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.

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.

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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).

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.

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.

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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.

FDA Study Finds Little Evidence of Antibiotics in Milk

March 5, 2015 3:50 pm | by MARY CLARE JALONICK, Associated Press | News | Comments

In an encouraging development for consumers worried about antibiotics in their milk, a new Food and Drug Administration study showed little evidence of drug contamination after surveying almost 2,000 dairy farms.

Flu Winds Down as FDA Aims for Better Vaccine Next Winter

March 4, 2015 11:46 pm | by LAURAN NEERGAARD, AP Medical Writer | News | Comments

The miserable flu season is winding down but not quite over yet, health officials said Wednesday, even as the government picked what it hoped would be a better vaccine recipe for next fall and winter.

FDA Approves Opdivo for the Treatment of Patients with Previously Treated Metastatic Squamous Non-Small Cell Lung Cancer

March 4, 2015 11:04 pm | News | Comments

Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

New FDA Official Inherits Numerous Projects, Challenges

March 3, 2015 8:13 am | by MATTHEW PERRONE, Associated Press; MICHAEL FELBERBAUM, Associated Press | News | Comments

One of the nation's leading medical researchers joined the Food and Drug Administration on Monday, taking on the agency's No. 2 leadership job at a critical juncture for prescription drugs, medical devices and tobacco products.

Pacira Pharma Slumps after FDA Ruling on Pain Drug

March 3, 2015 8:01 am | News | Comments

Shares of Pacira Pharmaceuticals tumbled Monday after the company said regulators refused to grant a new marketing approval for its post-surgical pain drug Exparel.

PBOA Supports FDA SOS Act

March 2, 2015 8:14 am | News | Comments

Bipartisan Act would preserve FDA user fees from sequestration.

Federal Charges Filed Against New Jersey Drug Company

February 27, 2015 8:17 am | by Andy Szal, Digital Reporter | News | Comments

Federal prosecutors have indicted a New Jersey compounding pharmacy and top company officials on 37 charges, including wire fraud and violations of federal drug safety laws.

Study Needed to Settle if Anesthesia Poses Risk to Babies

February 26, 2015 8:23 am | by LAURAN NEERGAARD, AP Medical Writer | News | Comments

Studies of baby animals have long suggested that going under anesthesia can have some harmful effects on a developing brain. Now some scientists want to find out whether those same drugs may pose subtle risks for human babies and toddlers.

Oklahoma Right to Try Drug Measure Approved by House Committee

February 26, 2015 8:18 am | by TIM TALLEY, Associated Press | News | Comments

Legislation that would give terminally ill patients in Oklahoma access to experimental medications that are not yet on pharmacy shelves could restore a sense of dignity to those who are dying, the measure's author said Wednesday.

FDA Approves New Antibiotic Combo from Actavis

February 26, 2015 8:11 am | News | Comments

Federal health officials have approved a new antibiotic combination to treat several hard-to-treat infections. The drug contains two ingredients, cephalosporin and avibactam, designed to help fight antibiotic-resistant bacteria.

Report: FDA Recalls Fell in Fourth Quarter of 2014

February 25, 2015 3:42 pm | by Andrew Szal, Editor, Pharmaceutical Processing | News | Comments

A recent report found that recalls of products overseen by the U.S. Food and Drug Administration fell during the final quarter of 2014 but the number of affected units increased.  

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