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FDA`

This page shows the latest FDA` news and features for those working in and with pharma, biotech and healthcare.

Finch Therapeutics bags $53m for microbiome therapies

Finch Therapeutics bags $53m for microbiome therapies

Earlier this year,   Finch gained a breakthrough therapy designation (BTD) from the FDA  for CP101. ... Diff candidate. Like Finch, Rebiotix received a BTD from the FDA, and both companies have products in  phase 3 clinical trials, which could make

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  • The evolution of real-world studies The evolution of real-world studies

    Ned Sharpless, Acting FDA Commissioner. Similar discussions are taking place across the Atlantic. ... Elsewhere, the EMA has compared the FDA’s real-world Sentinel safety system favourably to.

  • The Cystic Fibrosis Buyers’ Club The Cystic Fibrosis Buyers’ Club

    The movement proved to be hugely influential, and by the early 1990s its activism had spurred the FDA to introduce ‘accelerated approval’ that allowed experimental yet promising drugs to be made ... The FDA hadn’t been willing to override its

  • Streamlining clinical trials – why better data use is key Streamlining clinical trials – why better data use is key

    Big data, blockchain technology and artificial intelligence have given industry the chance to streamline drug trials, say experts, who agree with recent FDA calls for more efficient clinical research models. ... Dr Scott Gottlieb’s brief, energetic

  • 25 Women Leaders in UK Healthcare 25 Women Leaders in UK Healthcare

    Ruth has more than 80 publications to her name, and led the first genome-wide FDA submission of a hepatic adverse event and the first tumour-based analysis of an AstraZeneca

  • Rare disease trials Q&A Rare disease trials Q&A

    In its updated draft guidance on rare diseases published in February 2019, the US Food and Drug Administration (FDA) encourages pharma companies to involve patients, caregivers.

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90TEN is an award-winning healthcare communications consultancy that puts people at the heart of everything we do. Our Life.Changing. campaigns...

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