While a significant number of clinical trial delays occurred during the month of April, it was business as usual from a regulatory standpoint for companies with late-stage therapies ready for the market and for those targeting underserved patient populations.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Balt, Caredx, Hologic.
HONG KONG –Shanghai-based Zai Lab Ltd. has won an approval for the first innovative treatment for glioblastoma approved by China in more than 15 years, with the National Medical Products Administration’s (NMPA) nod for Optune in combination with temozolomide for use in patients with newly diagnosed glioblastoma (GBM), and also as a monotherapy for the treatment of patients with recurrent GBM.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Blueprint, BMS, Can-Fite, Clovis, Deciphera, Kancera, Leading Biosciences, Neuraptive, Seelos.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied DNA, Medalliance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Aim Immunotech, Cellphire, Enzychem, Immunic, Nordic Nanovector, Pharmazz, Restem, Sanofi, Scimount, Seattle Genetics, Takeda, Verona, Zealand.
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