Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioxcel, Calliditas, Histogen, Melinta, Oryzon, Pharmaessentia, Tetra.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA launches EUA safety dashboard; Fed Circuit claims mandamus jurisdiction in IPR institution; Comment period reopened on Orange Book patents.