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- FDA officials share guidance on de novo device classifications and upcoming MDUFA VI changes at MedTech ConferenceAt the MedTech Conference in Boston, FDA officials and industry experts discussed de novo classification requests. They offered practical tips for companies seeking de novo designation, stressing…
- After 2 patient deaths and cell therapy durability concerns, Artiva cuts 94% of workforceArtiva Biotherapeutics, which had been evaluating cell therapy AlloNK for the treatment of rheumatoid arthritis and other autoimmune diseases, is exploring strategic options that could include diss…BioSpace · 14d ago↗ source