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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
Press Releases
Aclarion Announces Presentation of Two Abstracts Highlighting Nociscan’s Growing Role in Real-World Clinical Practice
July 21, 2026
·
6 min read
Press Releases
Pasithea Therapeutics Announces Presentation of PAS-004 Data to European Society for Medical Oncology (ESMO) Congress 2026
July 21, 2026
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4 min read
Press Releases
Agios Provides Update on Phase 2 Trial of Tebapivat in Sickle Cell Disease
July 21, 2026
·
7 min read
Press Releases
Tempest Announces Development Collaboration with Senlang Biotechnology for TPST-4003, a CD7-Targeted Next-Generation In Vivo CAR-T
July 21, 2026
·
8 min read
Press Releases
Axiom Biosciences Announces Intention to Become the First U.S. Biotech to List on the Hong Kong Stock Exchange
July 21, 2026
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3 min read
Press Releases
Akari Therapeutics Enters Strategic Research Collaboration with Whitehawk Therapeutics
July 21, 2026
·
7 min read
Press Releases
Applied Biologics Initiates Multi-Center Real-World Outcomes Study of XWRAP® Across Chronic Wound Types
July 21, 2026
·
3 min read
Press Releases
Alterity Therapeutics to Participate in the Virtual BTIG Biotechnology Conference 2026
July 21, 2026
·
3 min read
Duchenne muscular dystrophy
Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ review
If approved, Dyne Therapeutics’ zeleciment rostudirsen could “capture the majority” of the exon-51 Duchenne muscular dystrophy market, given its better efficacy and dosing profile versus Sarepta Therapeutics’ exon-skipping therapy Exondys 51, the current standard of care, according to Oppenheimer.
July 21, 2026
·
2 min read
·
Jef Akst
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