File (record) – Page 2

Sanofi’s Tolebrutinib Shows Mixed Results in Phase 3 MS Trials, Plans for FDA Filing Remain

1 year ago talkbio0Tagged File (record), Multiple Sclerosis, Phase 3 trials, sanofi, Tolebrutinib, United States Food and Drug Administration

Tolebrutinib, Sanofi, Multiple Sclerosis, Phase 3 Trials, FDA Filing

Merck Acquires Curon’s Bispecific Antibody in $1.3B Deal; Legend Biotech Evaluates Options Amid Probes; Amgen’s FDA Filing Reveals Missing Adverse Events

1 year ago talkbio0Tagged Adverse event, amgen, Antibodies, Bispecific, CAR-T, Carvykti, China, Curon Biopharmaceutical, Evaluation procedure, File (record), Legend Biotech, Merck, United States Food and Drug Administration

Merck, Curon Biopharmaceutical , Bispecific antibody, Legend Biotech, Amgen, FDA filing, Adverse events, China investigations, CAR-T therapy, Carvykti

Novo Nordisk Pursues FDA Filing for Once-Weekly Insulin and Semaglutide Combo After Icodec Rejection

1 year ago talkbio0Tagged Clinical Research, COMBINE-1, File (record), Icodec, IcoSema, Insulin, Nordisk, once-weekly, regulatory approval, semaglutide, United States Food and Drug Administration

Novo Nordisk, insulin icodec, semaglutide, FDA filing, type 2 diabetes, once-weekly insulin, IcoSema, COMBINE-1 study, regulatory approval

Intra-Cellular’s Caplyta Triumphs in Major Depressive Disorder Phase 3 Trial, Edging Closer to FDA Filing

2 years ago talkbio0Tagged Caplyta, CGI-S, Clinical Global Impression Original Version Questionnaire, clinically, File (record), Intra-Cellular Therapies, Lumateperone, MADRS, MDD, Montgomery-Åsberg depression rating scale, Phase 3 trial, Positive, results, Severities, Statistical Significance, Unipolar Depression, United States Food and Drug Administration

Intra-Cellular Therapies, Caplyta, Lumateperone, Major Depressive Disorder (MDD), Phase 3 Trial, Positive Results, Statistically Significant, Clinically Meaningful, Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impression Scale for Severity of Illness (CGI-S), FDA Filing