All FDA articles – Page 4
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BusinessFDA’s first Duchenne drug approval reveals schism
Oligonucleotide drug reaches market amid pressure from patient families and strife over ‘patient-focused drug development’ at the regulator
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NewsUS agency bans triclosan and 18 other antibacterials
The FDA has banned 19 antimicrobials in the US and given industry a year to remove them from consumer products
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BusinessFDA urges labs to test all blood donations for Zika
Agency has also given emergency authorisation to two new Zika blood tests
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BusinessJuno CAR-T trial suspended after patient deaths
Immunotherapy study restarted with amended pre-treatment protocol
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OpinionTime for better incentives to keep drug costs low
Getting outraged at drug price hikes is all very well, but we need more constructive options
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BusinessJazz Pharma buy out Celator in $1.5bn deal
Deal centres on promising leukaemia drug fast-tracked by the US Food and Drug Administration
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BusinessIndia hit hard by US regulatory sanctions
Data integrity issues have led to punitive measures, but companies are taking measures to improve
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NewsUS drug giant will no longer supply lethal injection drugs
With Pfizer’s exit no US-approved pharma firm will sell its drugs to be used in executions
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BusinessFDA moves to withdraw swine drug carbadox
Carcinogenic antibiotic has been banned in EU, Canada and Australia for years
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NewsUS food and drug agency finally gets new head
The Senate has approved a new administrator for the Food and Drug Administration after months of delay and opposition
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Business
Merck & Co joins hepatitis C party
New drug adds new treatment options and increases competition in premium market
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NewsUS bans three food packaging chemicals
Food agency prohibits the use of three perfluorinated compounds linked to cancers in food-contact materials
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NewsReview calls for tighter controls on antibiotic use in farming
Legally binding targets are needed to tackle resistance worldwide, latest report says
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News
Pepsi sets limit on caramel colouring chemical
Firm establishes legal threshold for the caramel food colouring by-product 4-MEI that California lists as a carcinogen
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BusinessMerger fever sweeps pharma
The life sciences sector has been gripped by a mergers and acquisition frenzy, and it looks set to continue. But what does it mean for the industry?
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BusinessUS regulator reprimands Cepheid for norovirus diagnosis tool quality
Diagnostics firm has 15 days to respond to violations laid out by regulator
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Business
FDA takes action to remove biosimilars roadblock
The US Food and Drug Administration proposes system to name biosimilar drugs
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BusinessPorous pills could be largest industrial 3D printing use
US grants first-of-a-kind approval for Aprecia’s epilepsy tablets exploiting porous structure