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  • Wednesday, 27 April, 2022
    Pharmaceuticals sector
    McKinsey rebuts conflict claims over work for health regulator and opioid makers

    Congressional probe found 22 consultants had advised both the US FDA and drug manufacturers over a decade

  • Sunday, 17 April, 2022
    Anjana Ahuja
    Hasty approval for Alzheimer’s drug offers a cautionary tale

    FDA’s green light for aducanumab may delay development of more effective treatments for dementia, critics say

  • Friday, 8 April, 2022
    News in-depthPharmaceuticals sector
    US imposes strict curbs on contentious Biogen Alzheimer’s treatment

    Agency that controls spending by government health schemes will not fund drug for most patients

  • Thursday, 17 March, 2022
    Covid-19 vaccines
    AstraZeneca prepared to ditch effort to secure US approval for Covid vaccine

    UK drugmaker’s R&D chief says abandoning market would have little impact

  • Friday, 11 February, 2022
    Pfizer Inc
    Pfizer’s Covid vaccine for kids delayed after FDA postpones meeting

    US drugs regulator says it needs more time to evaluate low-dose jab for children under 5

  • Wednesday, 2 February, 2022
    The Big Read
    Gene editing: pig hearts and the new era of organ transplants

    After decades of false starts, scientists are beginning to believe that modified organs from animals can help solve the global shortage

  • Tuesday, 21 December, 2021
    Disease control and prevention
    US drugs regulator approves first injectable treatment to prevent HIV

    GSK product given as few as six times a year while current regimen requires daily pills

  • Friday, 12 November, 2021
    Biden’s nominee to lead FDA encounters pushback from some Democrats

    Concerns raised over Robert Califf’s previous stint at the US drugs regulator and its approach to the opioid epidemic

  • Tuesday, 9 November, 2021
    Covid-19 vaccines
    Pfizer asks US regulator to authorise Covid-19 boosters for all adults

    Food and Drug Administration had previously limited third doses to those who were vulnerable

  • Friday, 29 October, 2021
    Covid-19 vaccines
    FDA approves BioNTech/Pfizer jab for 5 to 11-year-olds

    US expected to become first country to authorise vaccine for younger children

  • Tuesday, 26 October, 2021
    Covid-19 vaccines
    FDA panel backs Pfizer Covid vaccine for 5- to 11-year-olds

    Data from drugmaker and US regulator suggest advantages of Covid-19 jab would far outweigh risks

  • Wednesday, 20 October, 2021
    Covid-19 vaccines
    FDA approves Moderna and J&J Covid booster shots

    People at high risk of catching coronavirus can now receive any of three vaccines authorised by US health agency

  • Saturday, 16 October, 2021
    Tobacco
    US sketches out tough regime for e-cigarettes with first authorisation

    Regulator signals it will allow devices to help smokers quit but not flavours popular with teens

  • Thursday, 14 October, 2021
    Covid-19 vaccines
    FDA advisers back Moderna’s Covid booster for at-risk groups

    Panel recommends third jabs for vulnerable people in step towards expanding US rollout of extra doses

  • Saturday, 25 September, 2021
    Coronavirus treatment
    Poisonings rise as Americans treat Covid with anti-parasitic drug

    Ivermectin has been touted by conservative commentators despite not being approved for use against virus

  • Thursday, 23 September, 2021
    Covid-19 vaccines
    FDA authorises Covid-19 booster shots for over 65s

    Agency decision to restrict third jabs to vulnerable Americans deals blow to Biden’s strategy

  • Friday, 17 September, 2021
    Covid-19 vaccines
    FDA panel votes against Pfizer’s Covid-19 booster jab application

    Advisory committee endorses third dose only for elderly and at-risk groups in blow to Biden

  • Wednesday, 15 September, 2021
    Covid-19 vaccines
    Pfizer and Moderna say Covid vaccine protection wanes over time

    Data come as US regulator weighs approval for booster shot to bolster immunity

  • Monday, 13 September, 2021
    Covid-19 vaccines
    Scientists who quit FDA criticise plan for widespread Covid vaccine boosters

    Pair who left agency two weeks ago among authors of scathing critique in academic journal

  • Monday, 23 August, 2021
    Covid-19 vaccines
    Biden urges vaccine mandates for workers after Pfizer jab approved

    US president’s message comes after first full approval for a Covid-19 shot by the Food and Drug Administration

  • Friday, 13 August, 2021
    Covid-19 vaccines
    US agency authorises Covid booster for vulnerable people

    FDA says additional dose of Pfizer or Moderna can be given to those who are immunocompromised

  • Thursday, 22 July, 2021
    Biogen Inc
    Biogen defends contentious $56,000 Alzheimer’s drug

    Pharma group blames ‘misinformation’ for overshadowing approval of therapy

  • Friday, 9 July, 2021
    FDA calls for probe of staff involved in divisive Alzheimer’s approval

    US drugs watchdog was under pressure after scientific outcry over controversial Biogen treatment

  • Tuesday, 22 June, 2021
    FDA chief under fire over Alzheimer’s drug decision

    US regulator’s approval of controversial treatment shows it is too close to Big Pharma, say critics

  • Tuesday, 22 June, 2021
    FT News Briefing podcast10 min listen
    US drug watchdog under fire, US Supreme Court rules against NCAA

    Top US drug regulator is accused of being too cosy with industry after approving Alzheimer’s drug

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