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FDA publishes a draft guidance on the content and format of certain diversity action plans intended to increase clinical study enr...[ Price : $8.95]
FDA approves a Verona Pharma NDA for Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disea...[ Price : $8.95]
BrainStorm Cell Therapeutics says it has reached alignment with FDA on chemistry, manufacturing, and controls aspects of the compa...[ Price : $8.95]
FDA sends AbbVie a second complete response letter on its NDA for ABBV-951 (for carbidopa/foslevodopa) for treating motor fluctuat...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Laboratory Developed Tests (LDTs): Small Entity Compliance ...[ Price : $8.95]
FDA accepts for review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) in combination with s...[ Price : $8.95]
FDA warns Cartersville, GA-based Sani-Care Salon Products about CGMP violations in its work as a contract manufacturer of finished...[ Price : $8.95]
FDA warns the Carmel, IN-based Indiana Lions Eye Bank about deviations from the regulations for human cells, tissues, and cellular...