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17 stories matching this filter · ← front page

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  • Experts suggest new safety framework to boost predictability of CNS toxicity assessments
    A recent paper outlines a safety framework intended to make central nervous system (CNS) toxicity predictions more reliable during drug development. The authors argue that new approach methodologi…
    raps · 6d agoNeutral↗ source
  • Definium's LSD pill shows positive results in late-stage anxiety trial
    Definium Therapeutics reported that its pharmaceutical-grade LSD formulation, DT120, achieved positive outcomes in a late-stage study targeting generalized anxiety disorder. The trial used a 56-po…
    BioPharma Dive · 10d agoPositive readoutPositive↗ source
73
fda recalls49
fda medwatch41
fda press28
917
Psychiatry & CNS727
Ophthalmology425
Pain406
Endocrinology & Metabolism390
Infectious Disease364
  • Definium's oral LSD candidate passes first Phase 3 trial in generalized anxiety disorder
    Definium Therapeutics announced that its oral LSD candidate has successfully completed a Phase 3 trial in generalized anxiety disorder. The study met its primary endpoints, marking the first of tw…
    Endpoints · 10d agoPositive readoutPositive↗ source
  • FDA approves Takeda’s orexin-2 drug Orzeyful for narcolepsy type 1
    The U.S. Food and Drug Administration has approved Takeda Pharmaceutical's new sleep medication, Orzeyful, marking the first product in the emerging orexin‑2 drug class. Orzeyful works by amplifyi…
    BioPharma Dive · 16d agoApprovalPositive↗ source
  • Supernus and Individor to merge, creating $2 billion brain-drug company
    Supernus and Individor announced a merger that will combine their portfolios of neurological medicines. The two firms together generated about $2 billion in revenue in 2025 from roughly a dozen CN…
    BioPharma Dive · 19d agoDealPositive↗ source
  • Supernus and Indivior announce all-stock merger to create CNS-focused drugmaker
    Supernus Pharmaceuticals and Indivior Pharmaceuticals have signed an all‑stock merger agreement to combine their businesses. The new company will be dedicated to developing treatments for central…
    Endpoints · 19d agoDealPositive↗ source
  • MapLight shares plunge 66% after mid-stage schizophrenia trial shows modest benefit but raises competitive concerns
    MapLight Therapeutics announced results from its mid‑stage trial of an experimental schizophrenia drug. The study enrolled adults experiencing an acute exacerbation of psychotic symptoms. The twic…
    BioPharma Dive · 26d agoPositive readoutNegative↗ source
  • Australia's TGA opens consultation to revamp rules for digital mental health tools
    The Therapeutic Goods Administration (TGA) has launched a public consultation aimed at updating the regulatory framework that governs digital mental health tools in Australia. The move seeks to cla…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Draig Therapeutics raises $65 million Series B to push depression drug targeting synapse repair
    Draig Therapeutics announced it has closed a $65 million Series B financing round that was oversubscribed. The capital will be used to advance its neuropsychiatry pipeline, with the lead program f…
    Endpoints · 1mo agoDealPositive↗ source
  • How mental health chatbots are trained on therapy sessions
    As people increasingly turn to AI for everyday tasks, companionship and emotional assurance, virtual mental health companies once wary of AI are racing to build out their own chatbots to stay compe…
    Endpoints · 1mo ago↗ source
  • 10 clinical trials to watch in the second half of 2026
    The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.
    BioPharma Dive · 1mo ago↗ source
  • HMNC Brain Health raises $50M Series B to advance two depression drugs
    HMNC Brain Health has secured $50 million in a Series B fundraise designed to support two psychiatry programs into mid-stage studies. The family-owned German drugmaker Medice led the Series B, whic…
    Endpoints · 2mo ago↗ source
  • Rapport ‘fully prepared’ to launch seizure drug solo, CEO says
    In a wide-ranging interview, Abe Ceesay detailed how Rapport built an investor syndicate and why the company is confident it can join the ranks of successful, commercial-stage brain drugmakers.
    BioPharma Dive · 2mo ago↗ source
  • Lilly, Gilead lead pharma’s M&A boom
    Deal volume in 2026 is substantially outpacing last year, and activity is being driven by interest in cancer and autoimmune disease drugs.
    BioPharma Dive · 3mo ago↗ source
  • Angelini to buy Catalyst in $4B play for rare neuro drugs
    The acquisition hands the Italian pharma a group of medicines approved to treat various CNS disorders and gives it wider market access in the U.S.
    BioPharma Dive · 3mo ago↗ source
  • Q&A: Seaport CEO and CSO on learning from Karuna and the future of CNS research
    Seaport Therapeutics began trading as a public company on Friday after executives rang the Nasdaq’s opening bell. Shares rose {$SPTX} more than 20%. With a team largely made up of Karuna Therapeuti…
    Endpoints · 3mo ago↗ source
  • Lilly tumbles on Foundayo’s shaky week; FDA to issue vouchers for psychedelics
    Lilly shares dipped, and Novo’s climbed, as Foundayo’s early trajectory diverged from that of oral Wegovy. Elsewhere, Regeneron inked a drug price deal and two companies announced leadership changes.
    BioPharma Dive · 4mo ago↗ source