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- FDA issues draft guidance to streamline approval of personalized gene therapies and expands CMS access modelThe Food and Drug Administration released a draft guidance that lets a single biologics license application cover multiple variants of a gene‑therapy product. The guidance introduces an Individuali…
- Astellas signs up to $1.34 billion option deal for Audax's DAX-044 immuno-oncology candidateAstellas Pharma announced it will pay up to $1.34 billion for an exclusive option to license Audax Biosciences' investigational antibody-cytokine fusion, DAX-044. The agreement includes an undiscl…