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It is not intended for human or animal use, and must not be misused in any way that contravenes MHRA regulations or applicable laws

The company plans to file a resubmission shortly, which it said would trigger another six-month review cycle and a new target action date

Nat Biotechnol

Minshall, R

Regulatory authorities advise assessing how renal and hepatic impairment affects the pharmacokinetics of new drugs, as this evaluation may indicate the need for dose adjustment in these populations [12,13,14,15]