Labels (device) – Talk Bio

Recent Advances Shifting Perspectives in Cell Therapy (2025)

7 days ago talkbio0Tagged CAR T-cell, Cell Therapy, Clinical Trials, controllable, CRISPR therapies, immune cells, Labels (device), Mesenchymal Stem Cells, patient-specific therapy, Solid Neoplasm, United States Food and Drug Administration, Updates

cell therapy; CAR T-cell; solid tumors; FDA label updates; mesenchymal stem cells; CRISPR therapies; patient-specific therapy; ultrasound controllable immune cells; clinical trials

Eli Lilly Touts ‘Striking’ Progression-Free Survival Results for Jaypirca in New Front-Line CLL Study

1 month ago talkbio0Tagged BRUIN, BTK inhibitor, Chronic Lymphocytic Leukemia, Clinical Trials, CLL, CLL-313, eli lilly, expansion, First line treatment, Jaypirca, Labels (device), Progression-Free Survival

Jaypirca; Eli Lilly; CLL; chronic lymphocytic leukemia; BRUIN CLL-313; progression-free survival; BTK inhibitor; first-line treatment; clinical trial; label expansion

Argenx’s Vyvgart Shows Positive Phase 3 Results in Seronegative Myasthenia Gravis

2 months ago talkbio0Tagged AChR-Ab, Adaptation, Argenx, expansion, Labels (device), LRP4 gene, Musk, Myasthenia Gravis, Phase 3, SERON, Seronegative, triple seronegative, United States Food and Drug Administration, Vyvgart

Vyvgart; Argenx; Phase 3; myasthenia gravis; seronegative; ADAPT SERON; AChR-Ab; MuSK+; LRP4+; triple seronegative; FDA label expansion

AbbVie and Genmab Move to Expand Use of T Cell Engager Epkinly Following Strong Phase III Results

2 months ago talkbio0Tagged AbbVie, Antibodies, Bispecific, Approved, Epcoritamab, EPKINLY, expansion, Genmab, Labels (device), lenalidomide, Lymphoma, Follicular, Phase 3 Clinical Trials, rituximab, T-Cell engager, United States Food and Drug Administration

Epkinly; epcoritamab; AbbVie; Genmab; follicular lymphoma; T cell engager; bispecific antibody; Phase III trial; FDA approval; label expansion; Rituximab; Lenalidomide

FDA Advisory Committee Unanimously Votes Against Expanding Pfizer’s Prostate Cancer Drug Combo

5 months ago talkbio0Tagged Advisory Committees, enzalutamide, expansion, Inhibitor, Labels (device), Malignant neoplasm of prostate, mCRPC, PARP1 gene, Pfizer, talazoparib, Talzenna, unanimous vote, United States Food and Drug Administration

FDA; advisory committee; Pfizer; Talzenna; talazoparib; enzalutamide; prostate cancer; mCRPC; PARP inhibitor; label expansion; unanimous vote

CHMP recommends seven label expansions and one new approval, rejects Lilly Alzheimer’s drug

7 months ago talkbio0Tagged Approved, CHMP, expansions, Labels (device)

CHMP, Labels (device), expansions, Approved

Bayer Seeks to Broaden Nubeqa’s Use in Prostate Cancer with Chemotherapy-Free Treatment Option

1 year ago talkbio0Tagged Antiandrogen therapy, ARANOTE, Bayer, Chemotherapy-free, Clinical Trials, darolutamide, expansion, Labels (device), Malignant neoplasm of prostate, Metastatic to, mHSPC, Nubeqa

Nubeqa, Bayer, prostate cancer, chemotherapy-free, label expansion, ARANOTE trial, darolutamide, androgen deprivation therapy (ADT), metastatic hormone-sensitive prostate cancer (mHSPC)

Incyte Seeks Expanded Approval for Monjuvi Following Successful Phase III Trial in Follicular Lymphoma

1 year ago talkbio0Tagged Approved, Cancer Therapeutic Procedure, expansion, Incyte, Labels (device), Lymphoma, Follicular, Monjuvi, MorphoSys, Phase 3 Clinical Trials, tafasitamab, United States Food and Drug Administration

Incyte, Monjuvi, follicular lymphoma, Phase III trial, label expansion, tafasitamab, MorphoSys, FDA approval, cancer treatment.

Novo Nordisk Withdraws FDA Submission for Wegovy’s Heart Failure Indication, Plans to Reapply Next Year

1 year ago talkbio0Tagged expansion, Heart failure, Labels (device), Nordisk, regulatory, Submission, United States Food and Drug Administration, Wegovy

Novo Nordisk, Wegovy, FDA submission, heart failure, label expansion, regulatory delay

BioMarin’s Brineura Receives Significant Label Expansion from FDA for Children Under 3 with CLN2 Disease

1 year ago talkbio0Tagged Alfa, BioMarin, Brineura, cerliponase, Child, Deterioration, expansion, Injection of therapeutic agent, Intraventricular, Labels (device), motor ability, Neurodegenerative, Symptoms aspect, TPP1 gene, United States Food and Drug Administration

BioMarin, Brineura, FDA, Label Expansion, CLN2 Disease, Children Under 3, Cerliponase Alfa, Intraventricular Injection, Motor Ability Deterioration, Neurodegenerative Symptoms