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- Disc’s rebuffed rare disease drug sets up FDA redo after ‘clean’ Phase 3 sweepDisc Medicine’s bitopertin—rejected by the FDA in February—significantly reduced levels of a key disease biomarker and significantly increased the time patients with erythropoietic protoporphyria w…BioSpace · 1d ago↗ source
- Induced pluripotent stem cells gain momentum as new methods and clinical successes drive drug developmentInduced pluripotent stem cells (iPSCs) are moving from a research curiosity to a practical tool in drug development. After years of steady progress, recent advances are bringing iPSCs into the spot…
- FDA issues warning letters to drug makers over CGMP lapses and highlights patient rep ties to industry-backed groups