All FDA articles – Page 6
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Business
Regulator cracks down on 23andMe
Personal genetic profiler ordered to stop selling DNA test kits
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Business
Pharma manufacturing woes dog industry
Regulators are stepping up inspections, and discovering ever more problems
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Business
Roche backs biologics boom
Swiss firm to invest heavily in manufacturing for complex biological drugs
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Business
First biosimilar antibody drugs approved in Europe
European commission gives final approval to generic infliximab copies
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News
Execution drug cannot be imported into US
Court rules that the Food and Drug Administration acted unlawfully allowing sodium thiopental into the country
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Business
Big data to sniff out drug marketing fraud
US Food and Drug Administration wants to track promotional spending to spot off-label marketing
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Business
Two new ‘personalised’ cancer drugs approved
Suitable patients for GSK’s melanoma treatments must be identified using an accompanying genetic test
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Business
Portable detector shines light on fake drugs
Testing for counterfeit antimalarials in Africa will help validate a new tool for inspectors
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Business
Morning sickness drug reintroduced to US
After being withdrawn due to litigation, the drug has been approved by the FDA
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Business
2012 pharma industry roundup
What were the bigger stories? And how did the industry fare overall?
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Business
Teva pulls generic antidepressant
FDA rules that Budeprion XL is not equivalent to Wellbutrin XL
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News
US bans BPA in baby bottles
Food and drug agency’s new prohibition on bisphenol A in baby bottles and sippy cups is being labelled by some as too little to late
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News
FDA green lights new obesity drug
Agency approval for prescription only obesity drug is first for 13 years
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Business
More testing needed for ridaforolimus
Marketing approval for anti-cancer drug ridaforolimus has been held up in the US
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Business
Drug watchdogs mark out global territory
US and European regulatory agencies are leading worldwide collaborations to ensure drugs from outside their borders are safe
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News
Voluntary controls on antibiotics on US farms criticised
The US Food and Drug Administration has introduced guidelines to try to cut antibiotic use in livestock
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News
FDA backs use of BPA in food packaging
Agency rejects petition to ban the use of BPA in food contact materials, citing insufficient research
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Business
US approves new anaemia drug
US authorities have approved Omontys (peginesatide) injections for treating anaemia in dialysis patients with chronic kidney disease