Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AVM, Cura, Mateon, Mediwound, Orphazyme.
BEIJING – Canbridge Pharmaceuticals Inc. last week won marketing approval in China for its first rare disease drug, the mucopolysaccharidosis II therapy Hunterase (idursulfase beta injection).
The FDA has granted Plus Therapeutics Inc. fast track designation for its lead candidate, Rhenium Nanoliposomes (RNL), for treating recurrent glioblastoma, propelling it into the sixth cohort of a phase I dose-finding trial.
The latest global regulatory news, changes and updates affecting biopharma, including: NIH adds funding to Latino Alzheimer’s research; Sprout warned for Addyi promotion; Scripps to pay $10M over use of NIH grants.
Mallinckrodt plc’s decade-long frustration with getting approval for its vasopressin analogue selective for V1 receptors, terlipressin, for use in hepatorenal syndrome type 1 continues as the FDA issued the company a third complete response letter (CRL) for the drug.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA advises on getting back to business as usual; ICER evidence report targets ulcerative colitis treatments.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Cycle, Essa, Gan & Lee, Gannex, Kiadis, Mateon, Novartis, Pharmacyte, Regeneron, Reven, Sanofi, SK, Seneca, Supernus, Vaxart, Vertex, Ziopharm.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Appili, Immupharma, Junshi, Seres, Sol-Gel.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch, Genmab, GSK, Halozyme, Sarepta, Terns, Zai Lab.
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