BioSpace News Archive

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• 

  FDA

  J&J Wins Proactive FDA National Priority Voucher for Multiple Myeloma Combo

  Johnson & Johnson, which did not apply for the national priority voucher, was granted the ticket based on results from a Phase III study testing Tecvayli plus Darzalex in patients with relapsed or refractory multiple myeloma.

  December 16, 2025

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  2 min read

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  Tristan Manalac
• 

  Venture capital

  Ambros Launches With $125M To Bring Italian Non-Opioid Pain Drug to America

  Ambros Therapeutics’ non-opioid bisphosphonate analgesic, already approved in Italy, will soon begin a pivotal test in the U.S.

  December 16, 2025

   · 

  1 min read

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  Annalee Armstrong
• 

  Approvals

  AstraZeneca, Daiichi Sankyo Move Enhertu to First-Line Metastatic Breast Cancer

  Analysts at Jefferies called the approval “highly significant,” estimating it could add $2 billion to $3 billion to peak Enhertu sales.

  December 16, 2025

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  2 min read

   · 

  Tristan Manalac
• 

  Rare diseases

  Kyverna’s CAR T Therapy Delivers ‘Impressive’ Mobility Benefits in Stiff Person Syndrome

  Kyverna plans to submit mivocabtagene autoleucel to the FDA for approval in the first half of 2026. If approved, it would be the first CAR T therapy for an autoimmune disease.

  December 16, 2025

   · 

  2 min read

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  Tristan Manalac
• 

  Vaccines

  Pfizer CEO Blasts HHS’ Anti-Vaccine Policies as Revenue Outlook Dims

  Pfizer CEO Albert Bourla defended his company’s vaccine business as rhetoric from HHS Secretary Robert F. Kennedy Jr. drives a notable drop in COVID-19 sales.

  December 16, 2025

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  3 min read

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  Annalee Armstrong
• 

  Alzheimer’s disease

  Sanofi’s Neuro Push Arrives in Seoul With $1B+ Alzheimer’s Play

  The star of the agreement targets a specific type of tau protein, helping to prevent toxic accumulation in the brain while also preserving the function of healthy tau.

  December 16, 2025

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  1 min read

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  Tristan Manalac
• 

  Vaccines

  Makary Denies FDA Plans To Levy Black Box Warning on COVID-19 Vaccines

  Speaking on Bloomberg TV on Monday, FDA Commissioner Marty Makary contradicted recent reporting that suggested the agency was planning to add a black box label—its most serious warning—to COVID-19 vaccines.

  December 16, 2025

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  3 min read

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  Heather McKenzie
• 

  Manufacturing

  Big Pharma Pushes FDA To Decouple Inspections From Drug Approval Applications

  Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.

  December 16, 2025

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  4 min read

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  Nick Paul Taylor
• Press Releases

  FibroBiologics Announces $1.7 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

  December 16, 2025

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  5 min read
• Press Releases

  NeuroSigma Completes $1 Million Investment into High-Volume Manufacturing Line for Second Generation Monarch eTNS® Device

  December 16, 2025

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  3 min read