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Say “sayonara” to the status quo of pharmaceutical promotional review. That’s the consensus of industry experts weighing the implications of the FDA’s decision Tuesday to settle Amarin’s First Amendment lawsuit. Read More
Amarin Pharmaceuticals will be able to promote its cholesterol drug Vascepa for off-label uses after resolving differences with the FDA in a free speech case involving off-label promotion of the capsules. Read More
European officials are pushing for greater synchronicity between the U.S. and EU regulators on generic approval processes as part of broader trade negotiations. Read More
An FDA advisory committee gave Celltrion’s biosimilar candidate for Remicade a strong show of support Feb. 9, backing its approval for six different indications. Read More