BioSpace News Archive

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• Press Releases

  Positive Phase 3 Results Support ZIIHERA® as HER2-Targeted Therapy-of-Choice and Combination with TEVIMBRA® and Chemotherapy as New Standard of Care in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma

  November 17, 2025

   · 

  19 min read
• 

  Government

  Signs of Frustration Build Between Kennedy and FDA Commissioner Makary

  Top Trump administration officials have taken issue with Marty Makary’s management style, pointing to infighting between his appointees and the difficulty to get a hold of the FDA commissioner.

  November 17, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Layoffs

  Sensei Down to a Handful of Employees to Wrap Up Development Activities

  Aside from announcing layoffs, Sensei has decided to terminate its R&D work. The biotech has $25 million on hand, and continues to evaluate its strategic alternatives.

  November 17, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Regulatory

  FDA Imposes Boxed Warning, Narrows Patient Pool for Sarepta’s Duchenne Gene Therapy Elevidys

  Sarepta must also run a post-marketing study for Elevidys to better assess the risk of serious liver injury in patients dosed with the gene therapy.

  November 17, 2025

   · 

  1 min read

   · 

  Tristan Manalac
• 

  Collaboration

  Lilly Bets More Than $2.6B for South Korea Biotech’s Bispecific Antibody Platform

  The companies have yet to disclose how many programs they plan to collaborate on or what indications they will prioritize.

  November 17, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• Press Releases

  PharmaTher Advances Strategy to Build Next-Generation Ketamine Franchise for Neuropsychiatric Disorders; Secures Exclusive Rights to Evaluate and License Patented Long-Acting Ketamine Program

  November 17, 2025

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  7 min read
• Press Releases

  Phio Pharmaceuticals Announces Upcoming Podium Presentation at the Advanced Therapies USA 2025 Congress

  Presenting INTASYL siRNA Drug Technology

  November 17, 2025

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  3 min read
• Press Releases

  Scryb Highlights New U.S. Institutional Fund Investment in Cybeats; Strengthens Long-Term Outlook

  November 17, 2025

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  4 min read
• Press Releases

  Theralase(R) Investor Conference Call Reminder

  Theralase(R) Reminds Investors of Conference Call to Provide Update on Study II Interim Data Demonstrating 64.3% Complete Response

  November 17, 2025

   · 

  5 min read
• Press Releases

  Adaptimmune Announces Changes to Board and Executive Leadership Team

  November 17, 2025

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  7 min read