regulatory approval

CHMP Rejects Sanofi’s Rezurock Over Clinical Data Issues, Recommends Approval of BTK Inhibitor Wayrilz

1 week ago talkbio0Tagged Autoimmune thrombocytopenia, belumosudil, cGVHD, CHMP, chronic graft-versus-host disease, Clinical Data, Inosine Triphosphate, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, regulatory approval, Rezurock, Rilzabrutinib, sanofi, Wayrilz

Sanofi; CHMP; EMA; Rezurock; Wayrilz; Belumosudil; Rilzabrutinib; chronic graft-versus-host disease; cGVHD; immune thrombocytopenia; ITP; regulatory approval; clinical data

Recent News: Gain Peace of Mind with the Lentiviral Experts

1 month ago talkbio0Tagged advanced manufacturing, Biological Factors, CAR-T therapy, gene therapy, Growth, immuno-oncology, lentiviral vectors, Market, regulatory approval

lentiviral vectors; CAR-T therapy; gene therapy; biologics; immuno-oncology; market growth; advanced manufacturing; regulatory approval

AstraZeneca gears up for FDA filing after baxdrostat’s phase 3 hypertension success

2 months ago talkbio0Tagged aldosterone synthase inhibitor, AstraZeneca, baxdrostat, File (record), Hypertensive disease, regulatory approval, United States Food and Drug Administration

AstraZeneca; baxdrostat; hypertension; FDA filing; aldosterone synthase inhibitor; phase 3 trial; regulatory approval

FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues

2 months ago talkbio0Tagged Biosimilars, Deferred, Edema, Eylea HD, macular, manufacturing issues, Nordisk facility, Pre-filled Syringe, Regeneron, regulatory approval, Retinal Vein Occlusion, United States Food and Drug Administration

FDA delay; Regeneron; Eylea HD; manufacturing issues; Novo Nordisk facility; biosimilars; pre-filled syringe; macular oedema; retinal vein occlusion; regulatory approval

Novo Nordisk Projects Slower Growth for 2025, Targets CagriSema Approval in 2026

9 months ago talkbio0Tagged 2025, CagriSema, Drug Industry, Growth, Nordisk, Obesity, regulatory approval, Sales - occupational activity, Wegovy

Novo Nordisk, 2025 outlook, CagriSema, obesity treatment, pharmaceutical industry, Wegovy, sales growth, regulatory approval

Biomarker Data’s Potential to Expedite Approval of Edgewise’s Dystrophy Drug

10 months ago talkbio0Tagged Becker, Biological Markers, Drug Development, regulatory approval

Biomarkers, drug development, Edgewise Therapeutics, Becker muscular dystrophy, regulatory approval

Agios’ Thalassemia Drug Mitapivat Faces Liver Injury Concerns Despite Second Phase III Success

11 months ago talkbio0Tagged Agios, ENERGIZE-T, Injury of liver, Mitapivat, Phase 3 Clinical Trials, regulatory approval, Thalassemia

Agios Pharmaceuticals, Mitapivat, Thalassemia, Liver Injury, Phase III Trials, ENERGIZE-T Study, Regulatory Approval

Sanofi Prepares for Regulatory Submission of Tolebrutinib in Non-Relapsing Secondary Progressive Multiple Sclerosis

1 year ago talkbio0Tagged BTK Inhibitor, Clinical Research, GEMINI 1, HERCULES, Multiple Sclerosis, non-relapsing, nrSPMS, regulatory, regulatory approval, sanofi, Tolebrutinib

Tolebrutinib, BTK inhibitor, Multiple sclerosis, Non-relapsing secondary progressive multiple sclerosis (nrSPMS), Sanofi, HERCULES study, GEMINI 1 and 2 studies, Regulatory approval