After being ushered onto the inside lane at FDA, regulators hand Amryt a CRL for rare disease drug - Endpoints News
2/28/2022 12:00:00 AM4 yearsago
by John Carroll
by John Carroll
Amryt may have earned a priority review for its drug to treat rare cases of epidermolysis bullosa (EB), but they got handed a CRL for their trouble in any case. The biotech reported Monday morning that the agency is demanding “additional confirmatory evidence…
Amryt may have earned a priority review for its drug to treat rare cases of epidermolysis bullosa (EB), but they got handed a CRL for their trouble in any case. The biotech reported Monday morning t… [+764 chars]
full article...