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A federal appeals court rejected a challenge by Otsuka Pharmaceuticals to the FDA’s decision to deny exclusive marketing rights to Otsuka’s antipsychotic injectable Abilify Maintena vis-a-vis a competing antipsychotic drug. Read More
FDA researchers are developing methods to examine and control chemical reactions that can impact the shelf-life, quality, safety and efficacy of protein-based biopharmaceuticals. Read More
The ICH has finalized a Q&A document clarifying its advice on the selection and justification of starting materials used in drug manufacturing. Read More
An FDA advisory committee voted 13-to-1 in favor of adding a warning about the risk of gadolinium retention to prescribing information for gadolinium-based contrast agents used in MRI scans. Read More