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University researchers say they found relatively few instances in which Oncology Drugs Advisory Committee members reported difficu...[ Price : $8.95]
CDER issues a white paper tracing the history of selective safety data collection (SSDC) and plans for the future.[ Price : $8.95]
FDA extends by three months its review of a GSK BLA for Blenrep (belantamab mafodotin) combinations for treating patients with rel...[ Price : $8.95]
FDA warns Grand Ledge, MI-based O3UV about multiple CGMP violations in its illegal production of autohemotherapy devices.[ Price : $8.95]
FDA warns Indias Glenmark Pharmaceuticals about CGMP violations in the production of finished drugs at one of its manufacturing fa...[ Price : $8.95]
FDA rejects a Replimune priority-reviewed BLA for its melanoma therapy RP1 (vusolimogene oderparepvec).[ Price : $8.95]
FDA wins the latest round in its regulatory battle against gene therapy maker Sarepta Therapeutics after the company agrees to sto...[ Price : $8.95]
Center for Medicine in the Public Interest president Peter Pitts says FDA must protect patients by tightening its regulation of co...