BioSpace News Archive

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• Press Releases

  Palvella Therapeutics Announces Expansion of QTORIN™ Rapamycin’s Development into Clinically Significant Angiokeratomas, a Rare, Chronically Debilitating Lymphatic Disease with No FDA-approved Therapies

  September 24, 2025

   · 

  7 min read
• Press Releases

  ESSA Pharma Inc. Amends Agreement with XenoTherapeutics

  September 24, 2025

   · 

  11 min read
• 

  Spinal muscular atrophy

  Biogen Receives Surprise FDA Rejection for High Dose Spinraza

  The regulatory action marks the second rejection for a spinal muscular atrophy therapy this week after Scholar Rock’s apitegromab was issued a complete response letter on Tuesday, similarly on manufacturing grounds.

  September 24, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Manufacturing

  Lilly Unveils Second Facility in Manufacturing Push, Naming Texas as Site of New $6.5B Plant

  Lilly expects to open 615 high-wage roles in Texas in connection with its new facility, plus around 4,000 construction roles.

  September 24, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Manufacturing

  FDA Hits J&J With Warning Letter Over ‘Significant Violations’ at Korean Production Plant

  The issues the regulator found include the failure to comprehensively review complaints and product defects.

  September 24, 2025

   · 

  2 min read

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  Tristan Manalac
• 

  Huntington’s disease

  UniQure ‘Exceeds Expectations’ in Much-Anticipated 3-Year Huntington’s Readout

  If approved, uniQure’s gene therapy AMT-130—which slowed disease progression by 75%—would be the first genetic treatment for Huntington’s disease. A BLA submission is planned for the first quarter of 2026.

  September 24, 2025

   · 

  2 min read

   · 

  Heather McKenzie
• Press Releases

  Independent Research Demonstrates Ruvidar(R) Effective in the Destruction of Herpes Simplex Virus

  September 24, 2025

   · 

  9 min read
• Press Releases

  Kneat Recognised as Leader in G2 Pharma and Biotech Fall 2025 Grid Reports

  Score based on User Satisfaction and Market Presence significantly exceeds peers

  September 24, 2025

   · 

  2 min read
• Press Releases

  Envoy Medical Advances Commercialization Planning for Breakthrough Hearing Device as FDA Clinical Trial Remains On Track

  The Company Begins Strategic Preparations To Support Anticipated Demand And Optimization Of The Acclaim® Fully Implanted Cochlear Implant Opportunity Six-month follow-up visits are now underway and will continue over the next two months

  September 24, 2025

   · 

  8 min read
• Press Releases

  Therma Bright Expands Relationship with Distribution Partner Gen-X Med for Venowave(TM) Sales

  Initial 200-Unit Sale previously announced on April 24, 2025, Targeted Specialized Knee Surgeons in U.S. Healthcare Network

  September 24, 2025

   · 

  4 min read