BioSpace News Archive

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  Sponsored

  How DIA Is Helping Regulators Turn AI Principles into Everyday Review Practice

  Through its AI Consortium and global forums, DIA is translating high‑level AI guidance into concrete workflows that match oversight to risk, from low‑stakes automation to decision‑critical regulatory analyses.

  February 16, 2026

   · 

  5 min read

   · 

  Maria Vassileva
• 

  Opinion

  2026 Could Mark a Turning Point for American Innovation

  The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.

  February 16, 2026

   · 

  4 min read

   · 

  John Stanford
• 

  Government

  ‘Just Agree to It:’ Pazdur Said He Was Told To Cosign FDA’s Reduced Trial Requirements

  Richard Pazdur had spent 26 years at the FDA before stepping down last year due to disagreements with Commissioner Marty Makary about lowering the number of clinical trials required for a new drug application, Pazdur told the media.

  February 16, 2026

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Complete response letters

  FDA Rejects Disc’s Rare Blood Disease Drug Amid Reports of Prasad’s Skepticism

  The FDA in October 2025 granted bitopertin its Commissioner’s National Priority Voucher but after a shortened review time has decided the data did not support regulatory approval for treating erythropoietic protoporphyria.

  February 16, 2026

   · 

  3 min read

   · 

  Tristan Manalac
• 

  CDC

  CDC Left Leaderless Again After Acting Director Departs HHS

  Jim O’Neill was deputy secretary at the Department of Health and Human Services and also acting director of the CDC after the abrupt ouster of Susan Monarez in August 2025.

  February 16, 2026

   · 

  1 min read

   · 

  Tristan Manalac
• 

  Vaccines

  Moderna’s mRNA Tech Could Boost Flu Shot Efficacy. Americans Will Have To Wait

  After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology.

  February 16, 2026

   · 

  3 min read

   · 

  Annalee Armstrong
• 

  Job Trends

  2025 Q4 Job Market Report: Positive Signs Emerge for Job Seekers

  BioSpace data show job postings live increased quarter over quarter, while layoffs fell year over year.

  February 16, 2026

   · 

  4 min read

   · 

  Angela Gabriel
• Press Releases

  CStone Announces FDA Clearance of IND Application for Its Novel Trispecific Antibody CS2009 (PD-1/VEGF/CTLA-4) to Advance into Phase II Clinical Trial

  February 16, 2026

   · 

  4 min read
• Press Releases

  Roche announces positive phase III results for Gazyva/Gazyvaro in primary membranous nephropathy, marking a significant milestone in this autoimmune disease

  February 16, 2026

   · 

  7 min read
• Press Releases

  Press Release: Beyfortus study published in The Lancet Infectious Diseases shows benefit for infants beyond first RSV season

  February 16, 2026

   · 

  8 min read