ScripAbeona Therapeutics obtained US Food and Drug Administration approval on 29 April for Zevaskyn, an autologous cell-based gene therapy for the ultra-rare connective tissue disorder recessive dystrophic
Pink Sheet“Pipeline in a pill”-style drug development will be on display in April, when more than half of the user fee goal dates are for new indications on sometimes sprawling labels, as well as one novel biol
Pink SheetOne-third of all the regenerative medicine advanced therapy (RMAT) designations granted by the US Food and Drug Administration’s Center for Biologics Evaluation and Research were awarded in fiscal yea
Pink SheetWhile the FDA is facing a disrupted and uncharted future, drug development offers a few certainties, including that oncology and neuroscience still dominate the novel agents seeking approval. But the