The BioTech Strategist

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Schlagwort: FDA approval

  • How Tharimmune’s TH104 Navigated the FDA’s 505(b)(2) Pathway

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    von

    Aisha Soraya Ahmad
    in

    From Simulation to Market: How Tharimmune’s TH104 Navigated the FDA’s 505(b)(2) Pathway to Address a National Security Threat The synthetic opioid crisis has evolved far beyond a public health emergency. When a substance fifty times more potent than heroin can be synthesized in a garage and weaponized as an aerosol, the line between pharmaceutical and…

  • Kriya Therapeutics $313M Funding

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    von

    Aisha Soraya Ahmad
    in

    Kriya Therapeutics‘ $313M Series Funding: Decoding the Investment Thesis Behind Nine-Asset Gene Therapy Pipelines in a Challenging Market The gene therapy sector exists in a peculiar state of simultaneous crisis and opportunity. On one hand, safety concerns mount as Sarepta’s Elevidys faces scrutiny following patient deaths and the FDA restricts bluebird bio’s Skysona due to…