Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cue Health.
As expected, Viela Bio Inc. won FDA clearance for the humanized anti-CD19 monoclonal antibody Uplizna (inebilizumab-cdon) to treat adults with neuromyelitis optica spectrum disorder (NMOSD), a rare neuroinflammatory disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adial, Biovie, Kite, Leap, Viela, ZZ.
Medtronic plc, of Dublin, has gained CE-marking approval for its Minimed 780g system, a next-generation closed-loop insulin pump for people with type 1 diabetes between the ages of 7 and 80 years old. The advanced hybrid closed-loop system (AHCL) features an advanced autocorrection algorithm and Bluetooth connectivity.
The U.S. FDA granted San Diego-based Illumina Inc. an emergency use authorization (EUA) for the first COVID-19 diagnostic test that uses next-generation sequencing (NGS). In addition to diagnosing infection with SARS-CoV-2, the COVIDSeq test can help researchers track mutations in the coronavirus.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Lucid Diagnostics, Moleculight, Palmetto GBA, Pavmed.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Establishment Labs, Medtronic.
The FDA Thursday approved Mylan NV’s Semglee (insulin glargine), adding another player to the U.S. insulin space that has been pretty much controlled by three companies – Eli Lilly and Co., Novo Nordisk A/S and Sanofi SA.
Due to the pressing challenges of COVID-19, Health Canada is giving drug companies six more months to prepare for major reforms to its 1987 Patented Medicines Regulations.
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