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A European Parliament committee is calling into question the safety of a pilot adaptive licensing pathway that would bypass traditional approval processes by the European Medicines Agency. Read More
The U.S. Supreme Court delivered Janssen a stinging rebuke on Monday, declining to hear its appeal of a $124 million penalty ordered by the Supreme Court of South Carolina over claims of deceptive advertising. Read More
The FDA has slapped India’s Cadila Pharmaceuticals with a warning letter for GMP violations — including a lack of quality controls, improper recordkeeping and inadequate investigations — at its Moraiya formulation plant and Ahmedabad API facility. Read More