Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Humanigen, Kite, Omeros, Xbrane.
Australia’s TGA provided updates regarding up-classification of several device types, including a number of spinal implants, which will henceforth be regulated as high-risk, class III devices, rather than medium-to-high risk devices (class IIb).
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Haemonetics, Siemens.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzamend, Alzinova, Basilea, Bexion, Cantargia, Diamedica, Glenmark, Immix, Jubilant, Liscure, Mirum, Pfizer, Reata, Selecta, TG.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Abbvie, Acacia, Alnylam, Amicus, Bridgebio, Catalyst, Eli Lilly, Everest, Helsinn, Pharmazz, Recursion, Taysha.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Ascentage, Cantargia, Incyte, Innovent, Lion, Novavax, Psybio, Serum, Wake.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Caretaker Medical, Wyss Center.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aim Immunotech, Astrazeneca, Eisai, Gilead, Humanigen, I-Mab, Iterum, Lipocine, MRM, Pfizer, Regeneron, Revelation, Sanofi, Viiv, Zogenix.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ANP Technologies, Breathesuite, Koya Medical, Medtronic, Nanowear, Nonagen, Seaspine, Selux Diagnostics.
RSS
