source
- Scholar Rock pulls Indiana fill-finish plant from SMA therapy filing after FDA flags violationsScholar Rock has removed Novo Nordisk's former Catalent fill‑finish facility in Bloomington, Indiana, from its regulatory filing for a spinal muscular atrophy therapy after the FDA classified the p…
- Hamilton Medical issues recall of coaxial breathing circuit sets for C1, T-1 and MR1 ventilatorsHamilton Medical has recalled specific coaxial breathing circuit sets used with its C1, T-1 and MR1 ventilators after the FDA classified the issue as a Class I recall, the most serious level, due t…