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The FDA could be increasing its recommendation on the amount of proposed suffixes — from three to 10 — that biosimilars applicants can propose for their products. Read More
BioMarin is calling it quits for its Duchenne muscular dystrophy candidate and three related products in its pipeline after the EMA’s Committee for Medicinal Products for Human Use signaled that it would not back the candidate. Read More
Chronic liver disease candidate Ocaliva and the self-administered multiple sclerosis treatment Zinbryta both snagged FDA approval late Friday. Read More