All FDA articles – Page 2
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BusinessUK grants Pfizer–BioNTech Covid-19 vaccine emergency approval
Regulators around the world working towards accelerated decisions on vaccine data
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NewsRush 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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OpinionHopes and fears for remdesivir
Available resources for testing coronavirus treatments need to be used wisely
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NewsSurvey 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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BusinessCan existing drugs slow Covid-19?
The fastest route to treatments may be to repurpose existing drugs – if they work
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BusinessFDA 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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BusinessCoronavirus 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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BusinessCancer 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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NewsSunscreen 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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BusinessUS 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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BusinessNitrosamine 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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OpinionUnder a cloud
Chemical detective work is needed to track down what’s been killing e-cigarette users
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NewsDeaths 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
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OpinionWill Novartis's data manipulation damage relations with regulators?
Trust between the two has been compromised
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NewsData manipulation casts shadows on Novartis gene therapy
Manufacturing problems with other new medicines highlight difficulty of developing advanced treatments
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OpinionIs this a golden age of new drug classes?
A host of new treatment modes are hitting the clinic and the market
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BusinessUS finalises guidance on biosimilars
Regulator clarifies requirements for allowing substitution between products
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NewsTelemedicine abortion provider locks horns with US drug regulator
Food and Drug Administration urged to take action against abortion charity by US politicians
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BusinessEmerging from the US opioid crisis
With litigation against suppliers in full swing, how does the US counter its addiction to powerful painkillers?