All FDA articles – Page 4
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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
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News
FDA reverses debarment of one of its ex-chemists
US Food and Drug Administration lifts ban on chemist who worked at the agency, more than 20 years after he was sentenced for taking bribes
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Business
US import ban imposed on Indian pharma firm
Concerns over manufacturing processes at Emcure facility prompts Food and Drug Administration to block drug shipments
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FeaturePharma queues up for checkpoint inhibitor collaborations
Combinations of different firms’ drugs seek to reap immuno-oncology’s benefits