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News about "USA FDA New Drug Application (sNDA)"

FDA Continues to Accelerate Development of Novel Therapies for COVID-19

FDA Continues to Accelerate Development of Novel Therapies for COVID-19

As part of the Trump Administration?s all-hands-on-deck approach across public, academic and private sectors to combat the COVID-19 pandemic, the U.S. Food and Drug Administration stood up a new program to expedite the development of potentially safe and effective life-saving treatments

USA FDA New Drug Application (sNDA) | 01/04/2020 | By Darshana 151

FDA expedites review of diagnostic tests to combat COVID-19

FDA expedites review of diagnostic tests to combat COVID-19

The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA?s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic

USA FDA New Drug Application (sNDA) | 31/03/2020 | By Darshana 103

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 New Drug Application (sNDA) | 26/03/2020 | By Darshana 116


 

 

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