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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...

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...

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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.

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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.  

Photo of the Day: Meningitis Vaccine

February 25, 2015 2:19 pm | by Mike Auerbach, Editor-In-Chief | News | Comments

Until recently, there was no vaccine available in the US to help protect against meningococcal group B, one of the most prevalent types of meningococcal meningitis in the US.

FDA Accepts Teva's NDA for Abuse-Deterrent Opioid

February 25, 2015 10:03 am | News | Comments

Teva Pharmaceutical Industries announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for the company’s hydrocodone bitartrate extended-release (ER) tablets formulated with Teva’s proprietary abuse deterrence technology (CEP-33237).

GSK's Nonprescription Diet Pill Back in Stores After Recall

February 25, 2015 8:08 am | by The Associated Press | News | Comments

GSK voluntary recalled Alli last March after finding some packages in stores didn't contain real alli, indicating tampering after shipment. The Food and Drug Administration is still investigating.

Watchdog Group Seeks US Ban of Antifungal Tablets

February 24, 2015 11:34 am | News | Comments

A consumer safety group is calling on the U.S Food and Drug Administration to pull certain antifungal tablets off the market, saying there are safer medicines that do not carry risks of liver damage.

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FDA Approves Farydak for Treatment of Multiple Myeloma

February 24, 2015 10:14 am | News | Comments

The U.S. Food and Drug Administration has approved Farydak (panobinostat) for the treatment of patients with multiple myeloma. Multiple myeloma is a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow.

NY AG Expands Herbal Supplements Investigation

February 24, 2015 8:25 am | by MARY ESCH, Associated Press | News | Comments

Three weeks after ordering four major retailers to pull store-brand herbal supplements off their shelves following DNA tests that found little or none of the listed herbs, New York's attorney general is targeting manufacturers of the popular products.

Lawyer: Teen Infected by 'Superbug' Struggling to Survive

February 20, 2015 2:58 pm | by ALICIA CHANG, AP Science Writer; JOHN ROGERS, AP Science Writer | News | Comments

An 18-year-old student is struggling to survive after he was infected by a "superbug" outbreak tied to contaminated medical instruments at a Los Angeles hospital, his attorney said.

FDA Eases Access to DNA Screening for Inherited Diseases

February 20, 2015 8:25 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal health officials are easing access to DNA tests used to screen parents for devastating genetic disorders that can be passed on to their children. The surprise announcement offers a path forward for Google-backed genetic testing firm 23andMe, which previously clashed with regulators over its direct-to-consumer technology.

FDA Issues Guidance for Drug Compounding, Repackaging

February 20, 2015 8:02 am | by Andrew Szal, Editor, Pharmaceutical Processing | News | Comments

The U.S. Food and Drug Administration recently issued a slew of proposed guidelines regarding drug compounding and repackaging under the Drug Quality and Security Act.

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FDA Expands Indication for REVLIMID®

February 19, 2015 11:46 am | News | Comments

Celgene Corporation has announced that the FDA has expanded the existing indication for REVLIMID® (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma (NDMM).

FDA Issues Warning as Peanuts Found in Cumin Spice

February 19, 2015 8:28 am | by MARY CLARE JALONICK, Associated Press | News | Comments

Hundreds of products are being pulled from store shelves after traces of peanut were found in cumin spice — a life-threatening danger to some people with peanut allergies.

FDA Grants Genentech’s Cobimetinib Priority Review for Use in Combination with Zelboraf in Advanced Melanoma

February 19, 2015 8:18 am | News | Comments

Genentech, a member of the Roche Group, announced the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company’s New Drug Application (NDA) for cobimetinib in combination with Zelboraf ® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma

Chemical Spray Tans May Pose Health Risk

February 18, 2015 8:39 am | Videos | Comments

Could misuse of the popular beauty treatment have impact on your health?

FDA Approves Eisai's LENVIMA for Thyroid Cancer

February 17, 2015 8:27 am | News | Comments

Eisai has announced that the FDA approved the company's receptor tyrosine kinase inhibitor LENVIMA (lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC).

After Lobbying Push, Sprout Pharmaceuticals Resubmits Women's Sex Pill

February 17, 2015 8:14 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

The makers of a twice-rejected pill designed to boost female libido are resubmitting their drug to federal health regulators, following a recent lobbying blitz by politicians, women's groups and consumer advocates aimed at pushing it onto the market.

FDA Clears New TB Test

February 13, 2015 8:25 am | News | Comments

The FDA has cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation.

FDA Announces Draft Guidance for Developing Drugs to Combat Alcoholism

February 13, 2015 8:15 am | by Andrew Szal, Editor, Pharmaceutical Processing | News | Comments

The U.S. Food and Drug Administration has filed a draft of its proposed industry guidelines for developing drugs to combat alcoholism, particularly regarding potential clinical trials.

Hospira Voluntarily Recalls Multiple Lots of Ketorolac Tromethamine Injection

February 11, 2015 11:49 am | News | Comments

Hospira has announced a voluntary recall of ketorolac tromethamine injection, USP in the United States and Singapore due to potential particulate. The presence of particulate has been confirmed through a customer report of visible, floating particulate identified in glass fliptop vials.

FDA Approves Genentech’s Lucentis® for Treatment of Diabetic Retinopathy in People With Diabetic Macular Edema

February 9, 2015 7:12 am | News | Comments

Genentech, a member of the Roche Group announced that the FDA approved Lucentis® for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME). DME impacts nearly 750,000 Americans, about 10 percent of people with DR.

FDA Chief Stepping Down, Chief Scientist to Take Over

February 6, 2015 8:23 am | by MARY CLARE JALONICK, Associated Press; MATTHEW PERRONE, Associated Press | News | Comments

Margaret Hamburg told employees of the FDA in an email that the agency's chief scientist, Stephen Ostroff, will serve as acting commissioner. She is among the longest-serving commissioners to head the agency and helped oversee the creation of a new food safety system, reforms in how drugs are reviewed and new tobacco regulations.

Hyperactivity Drug Approved for Binge-Eating Disorder

February 6, 2015 7:59 am | by Andrew Szal, Editor, Pharmaceutical Processing | News | Comments

The U.S. Food and Drug Administration has authorized using a hyperactivity drug for treatment of binge eating. The FDA originally approved Vyvanse in 2007 to treat attention deficit hyperactivity disorder in patients ages 6 and older.   

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