October 20, 2025 – Talk Bio

FDA Approves Roche’s Biogen-Partnered Gazyva for Lupus Nephritis

4 days ago talkbio0Tagged Biogen, Gazyva, Lupus Nephritis, obinutuzumab, Roche (company), treatment approval, United States Food and Drug Administration

Gazyva; obinutuzumab; Roche; Biogen; FDA; lupus nephritis; treatment approval

Tecentriq Demonstrates Survival Benefit in ctDNA-Guided Bladder Cancer Treatment at ESMO 2025

4 days ago talkbio0Tagged adjuvant treatment, atezolizumab, ctDNA-guided therapy, Disease-Free Survival, ESMO, genentech, IMvigor011, Malignant neoplasm of urinary bladder, muscle-invasive bladder cancer, Overall Survival, Roche (company), Signatera, Tecentriq

Tecentriq; atezolizumab; ctDNA-guided therapy; IMvigor011; bladder cancer; muscle-invasive bladder cancer; adjuvant treatment; overall survival; disease-free survival; ESMO 2025; Signatera; Genentech; Roche

Kezar Initiates Strategic Review After FDA Setback; Taysha Regains Full Rights to Rett Syndrome Program as Astellas Agreement Ends

4 days ago talkbio0Tagged Astellas, Autoimmune Chronic Hepatitis, Clinical Trials, Kezar Life Sciences, Rett Syndrome, setback, strategic alternatives, Taysha Gene Therapies, TSHA-102, United States Food and Drug Administration, Zetomipzomib

Kezar Life Sciences; FDA setback; strategic alternatives; zetomipzomib; autoimmune hepatitis; Taysha Gene Therapies; Astellas; Rett syndrome; TSHA-102; clinical trials

Roche Claims Its SERD Is Most Potent After Positive Breast Cancer Data Presented at ESMO 2025

4 days ago talkbio0Tagged ER-positive, giredestrant, HER2-negative, Malignant neoplasm of breast, Oral SERD, Phase 3 trial, Progression-Free Survival, Roche (company), Selective Estrogen Receptor Down Regulator

Roche; SERD; giredestrant; breast cancer; ESMO 2025; progression-free survival; oral SERD; ER-positive; HER2-negative; phase 3 trial

Diorasis Therapeutics Welcomes Dr. Dimitri Azar to Its Board of Directors

4 days ago talkbio0Tagged Biotechnology, board of directors, Clinical Development, Dimitri Azar, Diorasis, gene therapy, Glaucoma, Ophthalmology specialty, United States Food and Drug Administration

Diorasis Therapeutics; Dimitri Azar; Board of Directors; gene therapy; glaucoma; ophthalmology; biotechnology; FDA; clinical development

SystImmune Announces iza-bren Meets One of the Dual Primary Endpoints in the BL-B01D1-303 Trial in Recurrent or Metastatic NPC Patients with Results Presented at ESMO 2025

4 days ago talkbio0Tagged Antibody-Drug Conjugates, BL-B01D1 - 303, Epidermal Growth Factor Receptor, iza-bren, Nasopharyngeal carcinoma, ORR, Phase 3 Clinical Trials, SystImmune

SystImmune; iza-bren; BL-B01D1-303; Phase III trial; nasopharyngeal carcinoma; dual primary endpoints; ORR; antibody-drug conjugate (ADC); EGFR×HER3 bispecific; ESMO 2025