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Here is an explainer on why doctors are calling it a potential game changer even before it has been approved by the regulatory agencies like the US Food and Drug Administration (US FDA)

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In our case, there has been local tumor control of both metastases for 14 months so far

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Before PAHPRA, the distribution, dispensing, or use of products with extended expiry, and any related labeling adjustments, were possible through an EUA or FDA enforcement discretion