All FDA articles – Page 5
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News
NIH plan to get drug development unit back online
The US National Institutes of Health to address deficiencies in unit that makes drugs for research studies
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News
NIH drug manufacturing unit shut down
The US National Institutes of Health suspends operations at its pharmaceutical development section after FDA inspectors uncover serious manufacturing issues
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News
California demands warning labels for BPA
Despite safety evidence, the state has added BPA to its list of cancer-linked chemicals under ‘Proposition 65’
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Business
Injunction blocks first US biosimilar
Despite regulatory approval, Amgen is delaying sales of Sandoz’s version of filgrastim
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Business
FDA accused of violating drug company’s freedom of speech
Amarin says the regulator is stopping it from giving ‘truthful, not misleading’ information to doctors about its fatty acid drug
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Business
Drug firms warned to be honest with investors
Official warns of ‘significant consequences’ if companies aren’t forthcoming about their FDA interactions
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Business
US approves biosimilar filgrastim
Sandoz’s version of Amgen’s Neupogen is ‘biosimilar’ but not ‘interchangeable’
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NewsCaramel colour in soft drinks linked to cancer
Regulatory bodies and researchers sceptical of study on 4-MEI found in food colour
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BusinessUS opens up home DNA screening
FDA approves single disease genetic test and clears pathway for similar devices
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Business
Teva wins generic esomeprazole race
US approval of heartburn drug after Ranbaxy version was withdrawn by regulators
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Business
EU regulator calls for generic drug suspensions
The EMA wants hundreds of formulations off the market after identifying systematic fraud in a major Indian contract clinical research organisation
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BusinessUS poised to approve its first ‘biosimilar’ drug
FDA panel recommends Sandoz’s copy of Amgen’s Neupogen
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Business
Ranbaxy sues over withdrawn US approvals
Company says decision is ‘unconstitutional’ and deprives it of hundreds of millions of dollars in revenue
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Business
Single shot antibiotic approved for skin infections
Third drug in three months approved under US antimicrobials incentive scheme
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Business
Drug giants settle mismarketing lawsuits
Pfizer and GSK settle claims over promoting drugs for unapproved uses in the US
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Business
Generics giants jostle over pain drug
Mylan and Actavis contest Teva’s generic celecoxib exclusivity
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Business
Boehringer to settle blood thinner drug suits for $650m
Company confident in drug safety but says court cases are too risky
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Business
Contamination troubles strike GSK
GlaxoSmithKline is warned over contamination at an Ireland plant, and has recalled Alli from US retailers over tampering concerns.