All FDA articles
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PodcastDrugging the ‘undruggable’ cancer proteins & conserving the Bayeux Tapestry
How did molecular glues help crack one of cancer’s toughest targets? And we explore the chemistry behind the investigation and conservation of the Bayeux Tapestry.
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BusinessProtein degrading breast cancer drugs navigate bumpy road to market
Camizestrant is now approved in US, UK and Europe despite uncertainty over long-term benefit, while vepdegestrant is approved in the US
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BusinessUS approves pancreatic cancer treatment that targets ‘undruggable’ proteins
Daraxonrasib success offers hope of further approvals for Ras-inhibitor drug candidates targeting various cancers
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BusinessRegulators push Amgen to withdraw drug due to data manipulation
Questions raised over safety and efficacy of Tavneos (avacopan)
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NewsWhat kind of damage has RFK Jr’s health department inflicted on vaccine research in the US so far?
Since becoming health secretary in early 2025, Robert F Kennedy Jr has confirmed the worst fears of his critics
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BusinessUS FDA commissioner Makary resigns amid chaos and questions
Marty Makary’s departure, amid reports that Trump planned to fire him, is the result of an ‘inherited crisis’ and ‘shifting FDA standards’, BIO says
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OpinionModerna’s vaccine regulatory hokey-cokey
US FDA initially refused to accept flu vaccine for review, but has since reversed that decision
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OpinionTrump’s attack on science is shaking industry’s foundations
By dismantling scientific enterprise, the US risks ‘taking a hammer to our miracle machine’
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BusinessSarepta gene therapy deaths highlight tragic rare disease dilemma
Regulators block Duchenne muscular dystrophy treatment after fatal side-effects outweigh questionable efficacy
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BusinessUS approves natural food dyes while pushing to phase out synthetic colours
Government sets voluntary goal of removing artificial colours by 2027
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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