Actions from FDA this week include approval of a second targted treatment for a Duchenne muscular dystrophy mutation, and filings in COVID-19 and blood disorders.

FDA Updates: Assays Used in Cancer Care Get Green Light

By Mary Caffrey

August 9th 2020

Adaptive Biotechnologies’ clonoSEQ gets third approval; FDA also acts on first at-home treatment for spinal muscular atrophy.

Novartis defends data on its $2.1 million drug

By Christine Blank

August 12th 2019

While FDA recently said Novartis and AveXis did not reveal data on their $2.1 million gene thaerpy for pediatric spinal muscular atrophy until after it was approved, Novartis is defending its actions.

Pharma maker expands ibuprofen recall

By Christine Blank

February 5th 2019

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