The FDA rejects Cingulate's ADHD drug CTx-1301 over manufacturing deficiencies, underscoring that CMC compliance is now a primary gatekeeper for drug approvals and a critical differentiator for CDMOs.

The FDA approves Shionogi's XOCOVA (ensitrelvir) as the first and only oral antiviral for COVID-19 post-exposure prophylaxis, creating new API and intermediate manufacturing demand for 3CL protease inhibitors.

Taiwan-based Bora Pharmaceuticals acquires MacroGenics' FDA-inspected Rockville, Maryland biologics manufacturing facility for $122.5M, scaling end-to-end biologics CDMO capabilities.

Global CDMO CordenPharma acquires US-based peptide API specialist AmbioPharm, adding facilities in South Carolina and Shanghai to meet surging GLP-1 manufacturing demand.