BioSpace News Archive

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• 

  Opinion

  The FDA’s 505(b)(2) pathway is an underestimated engine of value creation

  The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.

  July 21, 2026

   · 

  6 min read

   · 

  Gail McIntyre
• 

  IPO

  Axiom plans Hong Kong IPO, hoping to carve new path for US biotechs

  Axiom Biosciences is thinking outside of the box, betting on a public debut in Hong Kong to raise capital and grow into a global company.

  July 21, 2026

   · 

  3 min read

   · 

  Gabrielle Masson
• Press Releases

  ESMO 2026 | Mabwell to Present Latest Clinical Data on Nectin-4-targeting ADC 9MW2821 for Triple Negative Breast Cancer in Oral Presentation

  July 21, 2026

   · 

  3 min read
• Press Releases

  Rege Nephro Secures approximately US$10.6 Million to Advance RN-014 Toward Commercialization

  July 21, 2026

   · 

  4 min read
• Press Releases

  Novartis delivered sales growth in Q2 and further advanced the pipeline; Full-year guidance reaffirmed

  July 21, 2026

   · 

  22 min read
• Press Releases

  Lupin Spins Out Two Oncology Programs to Kaveri Therapeutics to Advance its Oncology Strategy

  July 21, 2026

   · 

  3 min read
• Press Releases

  Innate Pharma Announces Completion of Enrollment in Phase 1 Dose Escalation Study of IPH4502, a Novel Nectin-4 Exatecan Antibody-drug Conjugate (ADC)

  July 21, 2026

   · 

  5 min read
• Press Releases

  OMEICOS’ OMT-28 Headed for Phase 3 in Primary Mitochondrial Diseases (PMD) Following Positive End-of-Phase 2 Meeting with the FDA

  July 21, 2026

   · 

  4 min read
• Press Releases

  Enterome Phase 2 data show EO2463-induced CD8 T-cell expansion correlates with progression-free survival in patients with indolent non-Hodgkin lymphoma in the watch-and-wait setting

  July 21, 2026

   · 

  6 min read
• Press Releases

  European Commission Approves Crysvita® (burosumab) for Infants with X-linked Hypophosphataemia in the European Union

  July 21, 2026

   · 

  6 min read