BioSpace News Archive

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• 

  Opinion

  Blood centers can help biopharma scale cell and gene therapies

  Blood centers have the donors, resources and community footprint drug sponsors need to solve supply chain issues around cell and gene therapies.

  September 15, 2026

   · 

  6 min read

   · 

  Becky Cap
• Press Releases

  Allumiqs Solutions Inc. and Allumiqs Corporation

  September 15, 2026

   · 

  1 min read
• 

  Regulatory

  Rare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meeting

  The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal years 2028–2032.

  September 15, 2026

   · 

  6 min read

   · 

  Heather McKenzie
• Press Releases

  RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE® (lazertinib) with prophylactic strategies shows low rates of treatment-related events at WCLC 2026

  September 15, 2026

   · 

  31 min read
• Press Releases

  Meiji Group to Showcase Japanese-Quality CMO/CDMO Services and a Global Manufacturing Network at CPHI Milan 2026

  September 15, 2026

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  2 min read
• Press Releases

  MaaT Pharma Receives Negative CHMP Trend Vote for MaaT013 (Xervyteg®) Following Re-Examination for its Conditional Marketing Authorization Application in Europe

  September 15, 2026

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  5 min read
• Press Releases

  Sensorion Announces the Completion of Its Reverse Share Split - September 15, 2026

  September 15, 2026

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  5 min read
• Press Releases

  Oral Presentation: Ivonescimab Versus Pembrolizumab in First-Line PD-L1-Positive NSCLC: Positive Overall Survival Results from HARMONi-2 at WCLC 2026

  September 15, 2026

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  7 min read
• Press Releases

  Eleva separates Bryotechnology platform and clinical-stage Factor H biotherapeutic into independent companies

  September 15, 2026

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  4 min read
• Press Releases

  One04 Therapeutics launches on encouraging CPV-104 Phase 1 interim results and plans to expand clinical development to include kidney diseases and dry AMD

  September 15, 2026

   · 

  4 min read