All FDA articles
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BusinessUS regulatory chief’s resignation raises alarms in biotech industry
FDA vaccines and biologicals centre director, Peter Marks, clashed with health secretary Robert F Kennedy Jr
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BusinessEnding of US weight-loss drug shortages prompts compounder complaints
Decision ends pharmacies’ permission to prepare versions of GLP-1 hormone mimics
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BusinessRed 3 dye banned in US food and drugs
Additive was already banned in US cosmetics and around the world
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BusinessUS approves schizophrenia drug with new mode of action
Cobenfy promises to better address negative symptoms than existing antipsychotics
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BusinessMDMA rejection poses questions for psychedelic drug trials
Decision prompts reflection over how psychotherapy is involved, regulating combination treatments and safeguarding patients
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OpinionThe US abortion drugs regulation challenge has stalled, but it will return
Having failed in the US Supreme Court, anti-abortion activists are trying other ways to prevent access to mifepristone
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OpinionFrom one sinking ship to another?
Biogen abandoning Alzheimer’s antibody aducanumab is unusual, but hardly surprising, says Derek Lowe
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BusinessPharmaceuticals roundup 2023
Regulatory and pricing reforms have topped industry agendas in 2023, while weight loss drugs surged and Covid-19 therapies waned
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BusinessLife-saving cancer gene therapy under investigation after being linked to rare secondary cancers
US drug agency examining six CAR-T therapies after reports of T-cell malignancies
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BusinessUS 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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BusinessAntibodies face Alzheimer’s reality
Companies are convincing regulators, but will doctors use them, and will providers pay for them?
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OpinionWill a court overturn abortion drug’s approval?
Tangle between regulation and politics makes uncomfortable viewing from industry
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NewsLab-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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OpinionAlzheimer’s, amyloid and abandoned antibodies
Biogen’s aducanumab is stumbling into obscurity. Where does that leave the amyloid hypothesis?
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OpinionWhen regulatory cooperation goes too far, we all lose
Were FDA staff unduly influenced by Biogen in approving Alzheimer’s antibody?
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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