Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomarin, Canbridge, Direct, Emmaus, Navidea, NLS, Ocugen, RDIF, Theratechnologies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Istar Medical, Palliare.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkeus, Antengene, Immunitybio, Kintor, Qualigen, Ryvu, Sesen.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Coaptech, Tidal Medical.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Arca, Artax, AVM, Evgen, Innovent, Moleculin, Oryzon, Targovax, Valo.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Beigene, Hangzhou Chance, Humanigen, Immutep, Innovent, Janssen-Cilag International, Moderna, Opthea, Recipharm, Replicel Life Sciences, Sciclone, Y-Mabs, Zydus Cadila.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: East End Medical, Stryker, Xenios.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Antengene, Bayer, Chemocentryx, Coya, Diurnal, Enochian, Gensight, Inotrem, Iveric, Janssen, Kintor, Prilenia, Provention, Seagen, Sigilon, Sirnaomics, Soleno, Tetra, Tevogen, Valneva.
Looking to increase adoption among more tobacco users, Carrot Inc. expanded the indications for use of its smoking cessation breathalyzer with a new FDA 510(k) clearance to include the claims related to a recent study in the labeling and promotion of the sensor. The clinical trial demonstrated the Bluetooth-enabled sensor’s ability to increase a person’s motivation to quit.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carrot, Quidel, Ortho Clinical Diagnostics, Uvision360.