Bespoke Gene Therapy 'Regulatory-as-a-Service'
FDA unveils rules for bespoke gene therapies, predicting a flood of rare disease applications via a new 'plausible mechanism' pathway.
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FDA unveils rules for bespoke gene therapies, predicting a flood of rare disease applications via a new 'plausible mechanism' pathway.
Eli Lilly's oral GLP-1 (Foundayo) is clearing safety hurdles. This signals the end of the 'cold chain' logistics nightmare and the beginning of mass-market oral adoption.
Abridge is integrating NEJM and JAMA data to move from passive transcription to active clinical decision support.
The 3rd Circuit ruled that UpCodes' publication of building standards is likely fair use, opening the door for startups to ingest and monetize technical standards that are incorporated into law.
Nubank ending free HBO Max signals the end of the 'subsidized growth' era in Brazilian fintech. Neobanks are now forced to focus on unit economics and credit spreads.
A former IBM engineer is building off-grid, modular retail units using Starlink and solar power to bypass traditional real estate constraints.