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Chinese vape manufacturers are using little-studied nicotine analogs to circumvent US flavor bans and FDA regulations, raising concerns about unknown health risks and addiction potential.
The FDA is set to discuss reclassifying peptides for compounding, with telehealth companies like Mochi Health and Hims & Hers preparing to cash in on the anticipated regulatory shift, driven by political influence from HHS Secretary RFK Jr. and the GLP-1 boom.
FDA advisors voted unanimously to approve Moderna's seasonal mRNA flu vaccine, mRNA-1010, after initial rejection by a Trump appointee. The vaccine showed 27% better efficacy than standard flu shot and stronger immune response than high-dose vaccine in older adults.
The FDA's rejection of UniQure's gene therapy AMT-130 for Huntington's disease has been overturned after the ouster of Trump officials, including regulator Vinay Prasad, who had demanded sham surgeries for a placebo control.
In a thread, @agupta agrees with @JTLonsdale's suggestions on the US biotech crisis and adds that the US should aggressively expand the research university system and 10x NIH and NSF budgets to leverage AI.
US biotech is in crisis as China surpasses the US in blockbuster pharma deals; the next FDA Commissioner must overhaul the agency and beat China to unleash cures.
Paperclip adds over 220K FDA regulatory documents and 1M clinical trials from multiple registries, enabling AI agents to search and reason over clinical and regulatory data without web search. This update allows users to query FDA documents, ClinicalTrials.gov, and international registries via a unified filesystem interface.
The FDA launches a pilot program using Causal AI to shorten clinical trial timelines for drugs and medical devices, potentially reducing trial duration by 20-40% and speeding regulatory approval.