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- Agios drops next-gen sickle cell drug after Phase 2 data show no advantage over Novo’s candidateAgios Pharmaceuticals said it is halting development of its next‑generation pyruvate kinase activator, tebapivat, for sickle cell disease after a mid‑stage trial failed to demonstrate a benefit ove…
- FDA’s 505(b)(2) pathway offers faster, cheaper drug development and commercial gainsThe FDA’s 505(b)(2) regulatory route lets drug sponsors build on existing safety and efficacy data while proposing meaningful changes to a known product. By leveraging prior findings, companies can…