BioSpace News Archive

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• 

  FDA

  Capricor, Replimune reviews signal FDA’s return to reliability but every application will stand alone

  Following a tumultuous stretch under ex-Commissioner Marty Makary, current FDA leadership is working to restore reliability, integrity and transparency to the agency—but experts say that doesn’t necessarily mean an easier regulatory road for drugmakers.

  August 24, 2026

   · 

  6 min read

   · 

  Tristan Manalac
• Press Releases

  Ainnocence Reports 91.4% Program Success Rate Across 58 Antibody Affinity Maturation Campaigns, Opens 28-Program Biologics Pipeline to Licensing

  Structure-free AI platform delivers picomolar leads while cutting wet-lab validation to 20-50 samples per round

  August 24, 2026

   · 

  1 min read
• Press Releases

  Rznomics Joins Lilly Gateway Labs in San Diego to Accelerate RNA Therapeutics

  August 24, 2026

   · 

  1 min read
• Press Releases

  Pulnovo Medical Announces First Two U.S. Patients Enrolled in PULSE-LHD IDE Clinical Trial of Pulmonary Artery Denervation in Treating Pulmonary Hypertension Associated with Left Heart Disease

  August 24, 2026

   · 

  8 min read
• Press Releases

  Hanmi Pharm Signs Exclusive Licensing Deal with Genentech for Novel Obesity Therapy

  August 24, 2026

   · 

  3 min read
• Press Releases

  GC Biopharma’s Hunter Syndrome Treatment ‘Hunterase’ Receives Drug Approval in India and Taiwan

  August 24, 2026

   · 

  3 min read
• Press Releases

  Vicore Pharma to Present at the European Respiratory Society Congress 2026

  August 24, 2026

   · 

  5 min read
• Press Releases

  ORZEYFUL (oveporexton) Approved in Japan as the First and Only Medicine to Treat the Underlying Cause of Narcolepsy Type 1

  August 24, 2026

   · 

  10 min read
• Press Releases

  Daiichi Sankyo Appoints Ken Keller as Chief Commercialization Officer to Lead New Commercialization Unit to Accelerate Growth of Innovative Portfolio

  August 24, 2026

   · 

  7 min read
• Press Releases

  European Commission Approves DAYBU® (trofinetide) as the First and Only Treatment for Neurobehavioral Symptoms of Rett Syndrome in the European Union

  August 24, 2026

   · 

  8 min read