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#神经

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Oct 5Mon
  1. fda.gov46

    FDA Seeks Public Input to Support Ibogaine Research

    The FDA issued a request for information on approaches it is considering for designing early-phase clinical trials of ibogaine drug products, covering dose selection and escalation, care setting, safety monitoring, eligibility, stopping rules and safety oversight. Proposed trial elements include small, sequential dose-ascending groups with a starting dose not exceeding 10 mg/kg, and monitoring for cardiac and neurologic adverse events. Comments can be submitted for 45 days via Docket No. FDA-2026-N-10429, closing November 20, 2026, and may inform FDA approaches to ibogaine drug development.

Sep 30Wed
  1. biospace.com63

    AbbVie wins FDA approval for Parkinson’s drug from $8.7B Cerevel takeover

    The FDA has approved tavapadon, branded Juvmo, for adults with Parkinson's disease, giving AbbVie a marketed asset from its $8.7 billion Cerevel Therapeutics acquisition. BMO calls Juvmo the first selective D1/D5 receptor agonist available in the U.S., usable with or without levodopa. AbbVie will list it at $4,900 per 30-day supply, or $58,800 per year, and expects U.S. availability next month, targeting a market opportunity the company puts at $5 billion.

    Why it matters: Approval salvages a product from the Cerevel deal after emraclidine failed, and launches a first-in-class Parkinson's option.

Sep 27Sun
  1. endpoints.news40

    AbbVie's next-gen dopamine therapy for Parkinson's gets FDA approval

    The FDA has approved AbbVie's tavapadon, a next-generation therapy for Parkinson's disease designed to provide symptom relief comparable to its predecessors with fewer side effects. No further details on dosing, launch timing or pricing were available. The approval gives Parkinson's clinicians a new dopamine-based treatment option.

    Why it matters: FDA approval of a new Parkinson's drug is direct news for clinicians and industry readers.

Sep 12Sat
  1. statnews.com72

    STAT+: Scholar Rock wins FDA approval for first drug to target SMA muscle loss

    The FDA has approved Scholar Rock's Isembyld, the first therapy to target muscle loss in spinal muscular atrophy, for adults and children aged 2 and older already receiving SMA therapies that target SMN2. In a late-stage trial, Isembyld combined with an SMN2-targeting drug improved young patients' motor skills over a year while placebo recipients declined, a statistically significant difference. Approval was granted on Friday.

    Why it matters: First FDA-approved drug targeting SMA muscle loss adds a new mechanism to existing SMN2 therapy.

Sep 10Thu
  1. fiercebiotech.com58

    Biohaven epilepsy drug suffers FDA hold days after attracting $350M deal

    The FDA has placed a hold on enrollment in trials of Biohaven's epilepsy drug candidate BHV-7000 after findings from rodent tests. The candidate is covered by a pending $350 million deal announced days before the hold. Biohaven has not disclosed how it will respond to the FDA.

    Why it matters: FDA halts enrollment in trials of a drug candidate tied to a pending $350 million deal.

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