The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA reissues policy for coagulation systems; FDA announces recall of Penumbra’s Jet 7; Stericycle to buy buses as part of settlement; Athena agrees to $18M fine; WHO refreshes essential diagnostics list; TGA pulls two pandemic-driven exemptions.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aziyo Biologics, Farapulse, Medtronic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Arvelle, Ascentage, Bellicum, Biogen, Biontech, Eisai, Gan & Lee, Incyte, Karyopharm, Mabxience, Novartis, Novo Nordisk, Pfizer, RDIF, Roche, Stada, Tetra, Vertex.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AC Immune, Fibrogen, Moleculin, Recordati, Rigel.