Novo’s Denecimig Got a Green Light From Clinicians and a Red Light From an Inspector: Who Failed?
FDA extended its denecimig BLA review over unnamed facility remediation failures, exposing the manufacturing blind spot that nearly every...
manufacturing compliance
When Your CMO Fails an FDA Inspection, Your Sites Pay the Price
Scholar Rock's BLA refiling for SMA drug apitegromab after Catalent Indiana's OAI classification shows how CMO inspection failures translate...
Scholar Rock’s Apitegromab Filing Exposes the CMO Due Diligence Gap That Keeps Burning Sponsors
Scholar Rock dropped Novo's Catalent plant from its SMA drug refiling after an OAI inspection. The compliance rot was...
When the Manufacturing Site Fails, the Clinical Site Pays the Price
Sanofi's Genzyme Ireland 483 and June 2026 warning letter show how CGMP failures at a manufacturing facility cascade into...
Sobi’s Gout CRL Is a Third-Party Manufacturing Indictment — And the Industry Wrote the Script
FDA issued Sobi a CRL for NASP on June 26, 2026, citing third-party manufacturing failures. Here's the operational breakdown...
When the Manufacturing Site Fails, Your Enrollment Plan Fails With It
Novo Nordisk's Bloomington facility hit with another FDA 483 — here's how manufacturing findings cascade into site enrollment holds,...