FDA bans Korean shellfish from US distribution 
Washington Post
In a message circulated to state public health authorities, the FDA said that the seafood should not be distributed, ?pending forthcoming details on what we might reasonably expect could be a fairly extensive recall of the product.
FDA warns against consuming Korean shellfish FIS
FDA Recalls Korean Fish Salineriverchronicle.com (blog)
Ag department issues consumer advisory for Korean shellfish Alexandria Echo Press

all 30 news articles » 

FDA Approves Generic Versions of Plavix 
Wall Street Journal
The FDA said it approved Dr. Reddy's Laboratories Ltd., Gate Pharmaceuticals, Mylan Pharmaceuticals and Teva Pharmaceutical Industries Ltd. to sell a 300-milligram dose of clopidogrel. Teva and Mylan have also been granted approval to sell a ...
FDA Approves Generic Clopidogrels As Plavix Loses Patent Protection Forbes
US FDA approves sale of generic Plavix Reuters
FDA Approves Generic Versions Of Blood-Thinning Drug Plavix NASDAQ
RTT News  -MarketWatch (press release)  -Benzinga 
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US approves drugs faster than Canada and Europe challenging criticisms that ... 
New York Daily News
Between 2001 and 2010, the FDA's typical review of a new drug was about 15 percent faster than those by the European Medicines Agency and Health Canada, its counterparts abroad, according to a study published Wednesday by the New England Journal of ...
Study: FDA outpaces the EMA on drug reviews, new approvals FierceBiotech
FDA Gets Good Marks on Speed of Approvals MedPage Today

all 106 news articles » 

FDA to Review CV Risk With Azithromycin 
Medscape
May 17, 2012 ? The US Food and Drug Administration (FDA) will review a new study showing that patients taking azithromycin (Zithromax, Pfizer) face a small increased risk for sudden cardiac death compared with patients taking amoxicillin ...
The FDA Is Faster. Now Let's Make It Safer Forbes
NEJM: Common antibiotic linked to a few CV deaths, prompting FDA review Cardiovascular Business
Azithromycin May Up Risk of Cardiac Death MedPage Today
Law360 (subscription) 
all 126 news articles » 

FDA panel backs first rapid, take home HIV test 
USA TODAY
The FDA will make its final decision on whether to approve the product later this year, weighing the opinion of the panel. Government officials estimate one-fifth, or about 240000 people, of the 1.2 million HIV carriers in the US are not aware they are ...
FDA panel backs at-home HIV test that analyzes mouth swab in 20 minutes CBS News
FDA Advisory Panel Approves Home HIV Test Kit ABC News (blog)
FDA Approves at Home HIV Test KAALtv.com
Washington Post  -BusinessWeek  -Wall Street Journal 
all 518 news articles » 

FDA Truvada Approval for Sexual HIV Prevention is an Error, States Dr ... 
San Francisco Chronicle (press release)
"The FDA Decision to approve Truvada* by 19 votes against 3 in the prevention of HIV transmission on May 11 is irresponsible and against Global Public Health Interests," declares Doctor Alain Lafeuillade, Head of the Department of Infectious Diseases ...
Do-It-Yourself HIV Test? FDA Considers Approval TIME
FDA panel OKs Truvada for HIV Prevention Bay Area Reporter
FDA panel recommends approving home HIV test Q13 FOX
KVAL  -Bloomberg 
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FDA warning hurts Hikma generics margins 
Reuters
In February, the company received a warning letter from the US Food and Drugs Administration (FDA) about operations at its Eatontown oral dosage facility in New Jersey. Hikma said it was enhancing its processes to address the regulator's observations ...

and more » 

Medgenics Receives FDA Clearance to Commence Phase IIb Trial of EPODURE for ... 
MarketWatch (press release)
"This timely acceptance of our first Investigational New Drug ("IND") to the FDA marks a significant milestone for our Biopump protein platform. We are very pleased with our US regulatory progress and with the interactions with the FDA, allowing us to ...
Medgenics cleared by FDA to begin Phase IIb clinical trials for EPODURE; shares up Proactive Investors USA & Canada
Medgenics Granted Clearance By US FDA To Carry Out Phase IIb Trial Of EPODURE RTT News
Medgenics gets FDA go-ahead for Epodure trial Stock Market Wire

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FDA to Start Regulating Sunscreen Labels 
KTXL
This summer, the FDA will begin regulating labels. Skin therapist Katie Pfadenhauer says this is great news. Katie works at a San Diego Salon & Spa. She often treats clients who've spent a touch too much time in the sun, and come to her, burned.
FDA Delays New Sunscreen Labeling Rules MedPage Today
More Good Sunscreens to Choose From this Summer Environmental Working Group
FDA requires new changes to sunscreen labels Fox 59
CBS News  -FoxReno.com  -BlissTree 
all 42 news articles » 

FDA Delays Sunscreen Label Redo 
NPR (blog)
But after companies complained they'd have trouble complying in time, the FDA gave them a reprieve. The agency was concerned that without an extension some companies might stop making some sunscreens and that there could be a shortage of so-called ...
FDA delays deadline for new US sunscreen labels Reuters
FDA delays sunscreen label changes by 6 months CBS News
FDA Gives Sunscreen Makers An Extension With Label Rules RedOrbit
TIME  -Fox News 
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