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Amgen is suing the FDA, requesting that its Sensipar medication be granted six additional months of pediatric market exclusivity after it completed three of four pediatric clinical trials requested by the agency. Read More
The FDA issued a warning to an Oklahoma drug manufacturer after inspectors found significant GMP violations, including a lack of product testing. Read More
Merck and Optum, a division of UnitedHealth Group, have launched a multi-year collaboration exploring value-based payment models for pharmaceuticals. Read More