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You are here: Industry Insights > risdiplam

News List

PTC Announces Regulatory Update on Risdiplam for Spinal Muscular Atrophy americanpharmaceuticalreview
April 13, 2020
PTC Therapeutics announced the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of risdiplam to August 24, 2020.
US regulator postpones decision on Roche’s SMA drug risdiplam pharmaceutical-technology
April 09, 2020
The US Food and Drug Administration (FDA) has postponed the decision on Roche’s new drug application (NDA) of risdiplam to treat spinal muscular atrophy (SMA).

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