cell and gene therapy– tag –
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Why Gene & Cell Therapies Stall at the FDA (2024–2025): What Recent CRLs Reveal about CMC, Inspections, and Trial Design
In July 2025, the FDA began publishing past Complete Response Letters (CRLs). Triangulating those releases with company disclosures and primary reporting shows two dominant themes: CMC (quality/manufacturing/testing) & Pre-License In... -
Biotech Investment News: Bayer’s Major Biotech Deals (2015–2025)
Strategic Review: Building a Cell and Gene Therapy Pipeline with BlueRock and AskBio Over the past decade, Bayer has transitioned from conventional pharmaceuticals into emerging modalities like gene editing, cell therapies, and regenerat...
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