regulatory approval

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

10 months 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

10 months 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

12 months 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

Translarna by PTC Therapeutics: Awaiting Another EU Regulatory Review for Muscular Dystrophy Treatment

1 year ago talkbio0Tagged ataluren, disease treatment, EU, European Medicines Agency, factor IX, Infrequent, Muscular Dystrophy, Muscular Dystrophy, Duchenne, regulatory approval, Translarna

PTC Therapeutics, Translarna, muscular dystrophy, EU review, regulatory approval, Duchenne muscular dystrophy (DMD), European Medicines Agency (EMA), ataluren, rare disease treatment.

Sanofi’s BTK Inhibitor Succeeds in Phase 3 LUNA Trial, Accelerating Regulatory Approval Race

1 year ago talkbio0Tagged BTK Inhibitor, Clinical Development, competition, Hematologic Neoplasms, LUNA, regulatory approval, sanofi

Sanofi, BTK inhibitor, LUNA trial, phase 3, regulatory approval, clinical development, blood cancer, competition