Labels (device) – Talk Bio

FDA broadens label for Amgen’s Uplizna as it enters rare disease competition

1 month ago talkbio0Tagged AChR-positive, amgen, Approved, disease market, dosing, expansion, gMG, IgG4-Related Disease, inebilizumab, Infrequent, Labels (device), MINT trial, MuSK-positive, Myasthenia Gravis, Generalized, Neuromyelitis Optica, twice-yearly, United States Food and Drug Administration, Uplizna

Uplizna; inebilizumab; Amgen; FDA approval; label expansion; generalized myasthenia gravis; gMG; AChR-positive; MuSK-positive; neuromyelitis optica spectrum disorder; NMOSD; IgG4-related disease; rare disease market; MINT trial; twice-yearly dosing

Eli Lilly’s Jaypirca pushes into first-line CLL, but commercial upside may be limited

1 month ago talkbio0Tagged Bruin-CLL-314, BTK inhibitor, ceiling, Chronic Lymphocytic Leukemia, CLL, eli lilly, expansion, First line treatment, ibrutinib, Imbruvica, Jaypirca, Labels (device), Market, oncology strategy, Pirtobrutinib, Progression-Free Survival, second-line treatment, SLL, traditional approval, United States Food and Drug Administration

Jaypirca; pirtobrutinib; Eli Lilly; chronic lymphocytic leukemia; CLL; small lymphocytic lymphoma; SLL; first-line treatment; second-line treatment; Bruin-CLL-314; Imbruvica; ibrutinib; BTK inhibitor; progression-free survival; FDA traditional approval; label expansion; market ceiling; oncology strategy

Eisai Expands Leqembi Subcutaneous Label, Accelerates Early U.S. Launch Progress for Alzheimer’s Disease

2 months ago talkbio0Tagged Alzheimer 's disease, at-home injection, dosing, Eisai, expansion, Labels (device), Leqembi, Maintenance, sBLA, starting dose, status - In progress, Subcutaneous Autoinjector, supplemental biologics, United States Food and Drug Administration

Eisai; Leqembi; subcutaneous autoinjector; label expansion; Supplemental Biologics License Application (sBLA); FDA; maintenance dosing; starting dose; early Alzheimer’s disease; at-home injection; launch progress

Recent Advances Shifting Perspectives in Cell Therapy (2025)

3 months 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

4 months 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

5 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

5 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

8 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

10 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)