The FDA posed a complete response letter to Biogen for a high-dose formulation of Spinraza demanding more manufacturing data, underscoring regulatory scrutiny in spinal muscular atrophy treatment development. Separately, Eli Lilly withdrew its $1.9 billion phase 2b trial for muscle-sparing obesity drug bimagrumab citing strategic reasons ahead of enrollment, reflecting shifting industry priorities. These developments highlight ongoing regulatory and strategic challenges biopharmaceutical companies face in advancing innovative therapies to market.