Covid-19 roundup: Regeneron nabs priority review for mAb; Preprint suggests mixing boosters is safe ahead of adcomms
Nearly a year after being granted an EUA, Regeneron and Roche’s Covid-19 antibody cocktail will now go before the FDA for a chance at full approval.
The big biotech announced Thursday it has submitted a BLA for the drug, shooting for an OK to treat Covid-19 in non-hospitalized patients and as prophylaxis in certain individuals. Regulators granted priority review, setting April 13, 2022 as the PDUFA date, and Regeneron said the agency is preparing an adcomm before then.
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