regulatory approval

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

1 week 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

3 weeks 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

7 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

9 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

9 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

12 months 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

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

Pfizer Strengthens Case for RSV Vaccine with Positive Data in Vulnerable Adults

1 year ago talkbio0Tagged Abrysvo, Clinical Trials, Immune response, immunocompromised adults, Pfizer, regulatory approval, Respiratory syncytial virus, Vaccines

Pfizer, RSV vaccine, Abrysvo, immunocompromised adults, clinical trial, immune responses, regulatory approval

Amber Therapeutics Raises $100M for Closed-Loop Neuromodulation Implant for Urinary Incontinence

1 year ago talkbio0Tagged amber, closed-loop implant, Neurostimulation/modulation, Pelvis, regulatory approval, Structure of pudendal nerve, U.S., United States, Urinary Incontinence

Amber Therapeutics, urinary incontinence, neuromodulation, closed-loop implant, funding, series A round, pelvic pudendal nerve, mixed incontinence, U.S. regulatory approval.

FDA Greenlights Biocon Biologics and Biogen’s Eylea Biosimilars: A New Era in Ophthalmology

1 year ago talkbio0Tagged Biocon, Biogen, Biological Factors, Biosimilars, Eylea, Ophthalmology specialty, regulatory approval, United States Food and Drug Administration

FDA, Eylea, biosimilars, Biocon Biologics, Biogen, ophthalmology, aflibercept, regulatory approval