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Pfizer has reached a tentative settlement with shareholders to end a class action suit alleging the company minimized the cardiovascular risks of taking Celebrex and Bextra. Read More
Spanish regulators are recommending that EU officials suspend a manufacturing certificate from a Chinese API maker over repeated issues at its plant. Read More
The EMA is mapping out trial designs for the development of therapies to treat Crohn’s disease, ulcerative colitis and mycobacterium tuberculosis. Read More
A compounding operation in North Carolina landed an FDA warning letter for compounding drugs without prescriptions and for sterility concerns. Read More
Two U.S. API makers are taking heat for a host of recordkeeping failures and related issues following FDA inspections of their production facilities. Read More