BioSpace News Archive

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• Press Releases

  BGI-Research and Global Partners Unveil Advanced Single-Cell Technology and Launch the “10 Billion Cells Alliance”

  August 22, 2025

   · 

  1 min read
• Press Releases

  U.S. Clinical Laboratory Services Market Size to Reach USD 16.18 Billion by 2034

  August 22, 2025

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  1 min read
• Press Releases

  Esaote Ultrasound systems MyLab™ A50 and MyLab™ A70 have received FDA approval

  August 22, 2025

   · 

  2 min read
• Press Releases

  Antengene Announces 2025 Interim Financial Results Highlighting Encouraging Data from Mid/Late-Stage Clinical Programs and Its Innovative TCE Technology Platform

  August 22, 2025

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  12 min read
• Press Releases

  Natera Technology Featured in 300+ Peer-Reviewed Publications, Underscoring Scientific Leadership in Precision Medicine

  August 22, 2025

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  2 min read
• 

  Manufacturing

  Novo-Acquired Catalent Plant Plagued by Unresolved Pest, Contamination Issues, FDA Finds

  Among the problems cited were cat hair, bacterial contamination and instrument defects.

  August 22, 2025

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  2 min read

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  Tristan Manalac
• Press Releases

  Lighthouse Pharmaceuticals Receives $49.2 Million Grant from NIA to Advance Phase 2 Study of LHP588 for P. gingivalis-positive Alzheimer’s Disease

  August 22, 2025

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  3 min read
• 

  Regulatory

  Krystal Cuts Melanoma Study of Viral Immunotherapy as FDA ‘Uncertainty’ Muddies Approval Pathway

  Krystal Biotech’s decision follows the FDA’s rejection last month of Replimune’s RP1, which works similarly to Krystal Biotech’s KB707. The biotech said this has introduced “heightened uncertainty” regarding a potential accelerated pathway for the candidate.

  August 22, 2025

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  2 min read

   · 

  Tristan Manalac
• 

  Approvals

  Ionis Wins Approval For First RNA-Targeted Prophylactic for Rare Swelling Disease

  The drug, for hereditary angioedema, is Ionis’ second wholly owned asset.

  August 22, 2025

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  2 min read

   · 

  Tristan Manalac
• 

  Regulatory

  After Court Win, Vanda Asks Makary To Review ‘Unacceptable’ Approval of Rival Generics

  Vanda claims that two generics to its sleep disorder drug Hetlioz were approved despite inadequate data and is requesting that FDA Commissioner Marty Makary revisit the decision.

  August 22, 2025

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  2 min read

   · 

  Tristan Manalac