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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
Two GOP senators are sounding off on the FDA over an advisory committee recommendation against Sarepta’s Duchenne muscular dystrophy treatment eteplirsen. Read More
The UK’s National Institute for Health and Care Excellence says it will not recommend Roche’s Perjeta, raising concerns about the lack of evidence backing the drug’s long-term benefits. Read More
The EMA’s Committee for Medicinal Products for Human Use is recommending approval for six drugs within the EU and another for export-only from EU countries. Read More