source
- FDA finalizes guidance aligning biosimilar post-approval manufacturing changes with global standardsThe U.S. Food and Drug Administration has issued its final guidance on how biosimilar manufacturers can implement post-approval changes to their production processes. The new recommendations bring…
- First Tracks reports positive early-stage results for celiac drug ANB033First Tracks Biotherapeutics announced that its experimental celiac disease drug ANB033 showed statistically significant improvement in a six‑week early‑stage trial compared with placebo. The trial…