Clinical / R&D
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Latest From Research & Development
Clonal neoantigen immunotherapy developer Achilles Therapeutics tells the Pink Sheet how the regulatory landscape for advanced therapies might not be as tricky as it used to be.
Draft guidances reflect the agency’s thinking on when patients with HIV/hepatitis infection, brain metastasis, organ dysfunction or prior malignancies, as well as pediatric patients, should be enrolled in cancer trials; FDA also finalizes recommendations on adolescent enrollment in adult studies of oncology drugs.
New draft regulation will require state-level approval over high-risk and reproductive use of gene and cell technologies.
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