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Sanofi’s bid to expand the indication for its biologic Lemtrada to treat relapsing multiple sclerosis (MS) faces tough scrutiny by FDA advisors as agency reviewers say data supporting the application point to “serious and potentially fatal safety issues.” Read More
Aegerion Pharmaceuticals CEO Marc Beer’s televised comments about the company’s heart drug Juxtapid have drawn a warning letter from the FDA for failing to mention drug risks and promoting an off-label use. Read More
The Department of Justice is investigating a Phase III study of AstraZeneca’s (AZ) heart drug Brilinta, which analysts and experts say could revolve around allegations of data falsification. Read More