All FDA articles
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Business
US regulator says phenylephrine is ineffective as a decongestant
FDA will begin consultation on removing the drug from hundreds of over-the-counter remedies
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Business
Antibodies face Alzheimer’s reality
Companies are convincing regulators, but will doctors use them, and will providers pay for them?
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Opinion
Will a court overturn abortion drug’s approval?
Tangle between regulation and politics makes uncomfortable viewing from industry
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News
Lab-grown chicken nears the dinner table in the US
Upside Foods’ chicken filet product is the first cell-grown meat product to be declared safe for consumption by the FDA
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Opinion
Alzheimer’s, amyloid and abandoned antibodies
Biogen’s aducanumab is stumbling into obscurity. Where does that leave the amyloid hypothesis?
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Opinion
When regulatory cooperation goes too far, we all lose
Were FDA staff unduly influenced by Biogen in approving Alzheimer’s antibody?
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Business
UK grants Pfizer–BioNTech Covid-19 vaccine emergency approval
Regulators around the world working towards accelerated decisions on vaccine data
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News
Rush to approve Covid vaccine prompted by politics may end in disaster
Push by governments to pass a vaccine without appropriate evidence could damage fight against virus
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Opinion
Hopes and fears for remdesivir
Available resources for testing coronavirus treatments need to be used wisely
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News
Survey of US government scientists reveals politicisation worries under Trump
Political appointees and business influence blamed for damaging agencies’ ability to make science-based decisions
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Business
Can existing drugs slow Covid-19?
The fastest route to treatments may be to repurpose existing drugs – if they work
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Business
FDA freezes foreign facility inspections amid coronavirus pandemic
US regulator will rely on border checks and shared data, but some approval processes may be delayed
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Business
Coronavirus pandemic will disrupt international supply chains
Halted production and transport restrictions are straining industries that rely heavily on China for supplies
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Business
Cancer and rare diseases dominated 2019 drug approvals
More streamlined review processes and changing R&D priorities have contributed to sustained increase in new medicines
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News
Sunscreen chemicals absorbed into skin at rates that require further safety tests
US drug safety body finds six common sunscreen ingredients enter bloodstream rapidly
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Business
US bans most flavoured vaping cartridges
Cartridge-based e-cigarettes in flavours other than menthol or tobacco without regulatory approval will be removed from sale
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Business
Nitrosamine contamination withdrawals spread to new drugs
After ranitidine recalls, EU regulators instruct companies to review all their products for potential impurities
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Opinion
Under a cloud
Chemical detective work is needed to track down what’s been killing e-cigarette users
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News
Deaths from vaping-linked lung disease in US connected to vitamin E additive
Tocopheryl acetate implicated in 380 cases of severe lung disease and six deaths