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A histological diagnosis was performed as per minimum reporting standards in the BSG guideline

Both were removed from the FDA Category 2 list in April 2026 and are on the July 23 to 24, 2026 advisory agenda, but they cannot be compounded until the committee recommends them and the FDA completes rulemaking, which takes time

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Many community references include 2-4 week off-periods between cycles to allow fresh evaluation, although the rationale is community-derived rather than trial-validated

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