regulatory approval

FluoGuide Strengthens Leadership to Drive Clinical and Regulatory Advancements

1 month ago talkbio0Tagged board of directors, Camilla Harder Hartvig, Changing, Chief Operating Officer, Clinical Development, Donna Haire, FluoGuide, Leadership, precision cancer, regulatory approval

FluoGuide; leadership changes; Donna Haire; Chief Operating Officer; Camilla Harder Hartvig; Board of Directors; FG001; clinical development; regulatory approval; precision cancer surgery

Metsera Calls Pfizer’s Threats ‘Nonsense’ as Rift Between Companies Widens

1 month ago talkbio0Tagged Chancery, Delaware Court, drug acquisition, Litigation, Merger, Metsera, Novo Nordisk, Obesity, Pfizer, regulatory approval

Metsera; Pfizer; Novo Nordisk; merger dispute; litigation; obesity drug acquisition; regulatory approval; Delaware Court of Chancery

Dyne Therapeutics’ z-rostudirsen Shows Durable Efficacy, Supporting Positive Regulatory Outlook

1 month ago talkbio0Tagged Accelerated, Approved, Biological Markers, Clinical Trials, DELIVER (veterinary product), Dyne Therapeutics, Effectiveness, Functional improvement, Muscular Dystrophy, Duchenne, regulatory approval, z-rostudirsen

Dyne Therapeutics; z-rostudirsen; DELIVER trial; Duchenne muscular dystrophy (DMD); durable efficacy; regulatory approval; biomarkers; functional improvement; accelerated approval

Sirona Medical Receives FDA 510(k) Clearance for Advanced Imaging Suite, Expanding PET-CT and Class II Medical Device Functionality

1 month ago talkbio0Tagged Advanced Imaging Suite, capabilities, Class II Medical Device, Clearance, image management, PET/CT scan, radiological imaging, regulatory approval, Sirona Medical, United States Food and Drug Administration

Sirona Medical; FDA 510(k) clearance; Advanced Imaging Suite; Radiological imaging; PET-CT capabilities; Class II medical device; image management; regulatory approval

Unlocking Japan’s Potential in Rare Disease Drug Development: Recent Progress and Challenges (2025)

1 month ago talkbio0Tagged Clinical Trials, drug lag, Drugs, Orphan, innovation, Japan, pharmaceutical partnerships, Rare Diseases, regulatory approval

rare disease; Japan; orphan drug; drug lag; innovation; regulatory approval; pharmaceutical partnerships; clinical trials

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

2 months 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

3 months 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

3 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

4 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

10 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