source
- Industry groups back FDA’s proposed distributed manufacturing rule, seek clarification on implementationIndustry trade groups have expressed overall support for the FDA’s draft rule that would allow drugs to be produced using distributed manufacturing models. The proposal aims to modernize the supply…
- Immunovant halts lupus program after Phase 2b trial fails to meet efficacy endpointsImmunovant announced that its anti‑FcRn drug imeroprubart (IMVT‑1402) did not achieve the primary endpoint in a Phase 2b study in patients with cutaneous lupus erythematosus. The double‑blind tria…