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 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.
The latest global regulatory news, changes and updates affecting biopharma, including: Retiring lawmakers urge 340B modernization; How human are ‘human antibodies’?; ANDA suitability MAPP updated; MHRA: Drug interactions possible with COVID-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axovant, CTI, Inventiva, Nanobiotix, Nuvation, Pluristem, PMV, Prestige, Voyager.
New York-based Avenue Therapeutics Inc. took receipt from the FDA of a surprise complete response letter (CRL) – characterized by Wainwright analyst Joseph Pantginis as “bizarre” – with regard to the NDA for intravenous (I.V.) tramadol in acute pain.
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.
The latest global regulatory news, changes and updates affecting biopharma, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alexion, Avenue, Astrazeneca, Celltrion, Gannex, Immunomedics, Oncopeptides, Oxular.
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