FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identified at Catalent Indiana LLC Fill-Finish Facility – Scholar Rock

Business News

  1. FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identified at Catalent Indiana LLC Fill-Finish Facility  Scholar Rock
  2. US FDA declines to approve Scholar Rock’s muscle weakness drug; shares fall  Yahoo Finance
  3. (ARCH-backed) Rome has fallen  statnews.com
  4. FDA rejects Scholar Rock’s SMA drug, citing issues at Novo’s Catalent Indiana site  Fierce Pharma
  5. FDA hands Scholar Rock a CRL for spinal muscular atrophy drug  Endpoints News

Source: Business News

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