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News about "USA FDA"

Pfizer’s sNDA for Eucrisa to treat children as young as 3 months of age with mild-to-moderate AD receives US FDA approval

Pfizer’s sNDA for Eucrisa to treat children as young as 3 months of age with mild-to-moderate AD receives US FDA approval

Pfizer announced that the US Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Eucrisa (crisaborole) ointment, 2%, extending the lower age limit from 24 months down to 3 months in children with mild-to-moderate atopic dermatitis (AD), also known as eczema

USA FDA | 26/03/2020 | By Darshana

Genentech gets US FDA nod to begin clinical trial for Actemra to treat hospitalized patients with severe COVID-19 pneumonia

Genentech gets US FDA nod to begin clinical trial for Actemra to treat hospitalized patients with severe COVID-19 pneumonia

Genentech, a member of the Roche Group, announced the US Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of intravenous Actemra (tocilizumab) plus standard

USA FDA | 26/03/2020 | By Darshana

Insulin Gains New Pathway to Increased Competition: USA FDA

Insulin Gains New Pathway to Increased Competition: USA FDA

Today is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway. This regulatory transition, mandated by Congress and implemented by the FDA, is incredibly important for patients

USA FDA | 24/03/2020 | By Darshana 161


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