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    GlossaryRegulatory Approval

    official authorization from agencies to market a product

    Regulatory approval is the official authorization granted by governmental or regulatory agencies, such as the FDA in the United States, allowing a product, such as a new medication or medical device, to be marketed and sold. This process involves rigorous evaluation of the product's safety, efficacy, and quality through clinical trials and other scientific assessments to ensure it meets the required standards for public use.

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      signaling protein that, when suppressed, may grow hair by reducing inflammation and stem cell loss

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      community Why doesn't phase 3 of PP405 start straight away?

      in Chat  14 upvotes 3 months ago
      Pelage is delaying the start of phase 3 trials for PP405 to 2026 due to necessary regulatory processes, despite having $120 million in funding. Users discuss the potential of PP405 for hair regrowth, with some expressing skepticism and others hopeful for new treatments like Breezula.

      community Breezula 6 Month Topline Phase III Results Released

      in Research/Science  171 upvotes 4 months ago
      Breezula shows promising hair growth results, with up to 539% increase in hair count compared to placebo, and regulatory submissions are planned in the US and EU. Users are cautiously optimistic, noting the potential for Breezula to replace finasteride by targeting DHT without systemic effects.

      community Good News, PP405 is out on Shopee

      in Product  266 upvotes 1 month ago
      A product called "PP405 Hair Follicle Serum" is being sold on Shopee, claiming to cure baldness without clinical trials or FDA approval, but users are skeptical and refer to it as "snake oil." Some users discuss testing the product's contents, while others share their experiences with hair loss treatments like finasteride.