BioSpace News Archive

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  FDA

  FDA Expert Panels Lack Balance in Pursuit of ‘Gold Standard Science’

  New FDA expert panels, such as recent meetings on SSRI use during pregnancy and on hormone replacement therapy during menopause, are drawing criticism for being one-sided. One leader says such panels are designed to reach a specific conclusion.

  September 8, 2025

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  6 min read

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  Ben Hargreaves
• Press Releases

  Epigenic Therapeutics Announces Completion of $60 Million Series B Financing to Accelerate Clinical Development of Epigenetic Medicines

  September 8, 2025

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  5 min read
• Press Releases

  Eisai Presents Clinical Study Results of Novel Orexin Receptor Agonist E2086 for Narcolepsy at World Sleep 2025

  September 8, 2025

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  5 min read
• Press Releases

  Innovent Announces Phase 2 Results of Tigulixostat (IBI128, XOI) in Gout Patients were Published at the 27th Asia-Pacific League of Associations for Rheumatology Congress

  September 8, 2025

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  10 min read
• Press Releases

  IDEAYA Biosciences and Hengrui Pharma Present Positive Phase 1 Data for IDE849 (SHR-4849), a Potential First-in-Class DLL3 TOP1 ADC, in Small Cell Lung Cancer at the IASLC 2025 World Conference on Lung Cancer

  September 8, 2025

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  7 min read
• Press Releases

  Dianthus Therapeutics to Host Conference Call and Webcast to Discuss Results from Phase 2 MaGic Trial of Claseprubart (DNTH103) in Generalized Myasthenia Gravis

  September 8, 2025

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  1 min read
• Press Releases

  InnoCare Announces Approval of HIBRUKA (Orelabrutinib) for the Treatment of Marginal Zone Lymphoma in Singapore

  September 8, 2025

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  2 min read
• Press Releases

  Data published in The New England Journal of Medicine demonstrate RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) is re-setting survival expectations in first-line EGFR-mutated lung cancer

  September 8, 2025

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  33 min read
• Press Releases

  Ivonescimab Plus Chemotherapy Demonstrates Consistent Global Benefit: HARMONi Data Update Shows OS HR=0.78, Nominal P=0.0332

  September 8, 2025

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  10 min read
• Press Releases

  Junshi Biosciences Announces the Phase 3 Study of JS005 (IL-17A) for the Treatment of Moderate to Severe Plaque Psoriasis Met Primary Endpoints

  September 8, 2025

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  5 min read