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A Newsweek report details four major issues it says have plagued FDA in its first year under commissioner Marty Makary.[ Price : $8.95]
FDA cites a U.K.-based clinical research center for failing to promptly report adverse events and for potential falsification of s...[ Price : $8.95]
Vertex Pharmaceuticals says an interim analysis of its Phase 3 RAINIER trial showed its experimental therapy povetacicept signific...[ Price : $8.95]
FDA accepts for review a Capricor Therapeutics BLA resubmission for its experimental cell therapy deramiocel, intended to treat he...[ Price : $8.95]
FDA approves an expanded use of GSKs Wellcovorin (leucovorin calcium) tablets for treating cerebral folate deficiency in adult and...[ Price : $8.95]
FDA warns Westphalia, Germany-based Simtra BioPharma Solutions about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA warns Novo Nordisk in Plainsboro, NJ, about its failure to meet postmarketing adverse drug experience reporting requirements.[ Price : $8.95]
FDA warns Frances Fareva about CGMP violations in the production of finished drugs at its Morton Grove, IL, manufacturing facility...