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FDA regulatory news, clinical trial policy, drug approvals, and the regulatory frameworks shaping the biotech industry.
1 article

Peptide therapeutics are a $140B market, but the peptides everyone's talking about online — BPC-157, TB-500, melanotan II — aren't FDA-approved for humans. Now HHS Secretary RFK Jr. is personally reversing a 2023 FDA safety determination, over the objections of the officials who wrote it.
Late-Stage De-risked / Blockbuster Potential