In Regeneron Pharmaceuticals Inc.’s Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn), the FDA has approved its first ever treatment for the Ebola virus in pediatric and adult patients.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apexigen, Armata, Eton, Merck, Immunitybio, OS, Regeneron, Zhittya.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aferetica, Cytosorbents, New World Medical.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA taking adcomm nominations; HHS, DoD ink deal with Cue Health; NTAP town hall set for Dec. 15-16.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Biohaven, Direct, Enlivex, Harmony, Moderna, Orca, Redhill, Scynexis, Sorrento, Taysha Gene, Tevogen, Y-mabs.
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has approved an additional indication for CT-P59, Incheon-based Celltrion Inc.’s anti-COVID-19 monoclonal antibody.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cefaly Technology, Crossbay Medical, Fh Ortho, Immersivetouch, Micro Medical Solutions, Sonivie.
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