2025
FDA Approves Roche’s Biogen-Partnered Gazyva for Lupus Nephritis
Gazyva; obinutuzumab; Roche; Biogen; FDA; lupus nephritis; treatment approval
Tecentriq Demonstrates Survival Benefit in ctDNA-Guided Bladder Cancer Treatment at ESMO 2025
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
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
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
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
SystImmune; iza-bren; BL-B01D1-303; Phase III trial; nasopharyngeal carcinoma; dual primary endpoints; ORR; antibody-drug conjugate (ADC); EGFR×HER3 bispecific; ESMO 2025
Roche Inks $80M Upfront Deal for Hansoh’s Cancer ADC HS-20110
Roche; Hansoh Pharmaceutical; ADC; HS-20110; CDH17; colorectal cancer; solid tumors; licensing deal; upfront payment; milestone payments; royalties
CHMP Rejects Sanofi’s Rezurock Over Clinical Data Issues, Recommends Approval of BTK Inhibitor Wayrilz
Sanofi; CHMP; EMA; Rezurock; Wayrilz; Belumosudil; Rilzabrutinib; chronic graft-versus-host disease; cGVHD; immune thrombocytopenia; ITP; regulatory approval; clinical data
FDA Announces First Recipients of Makary’s National Priority Voucher Program, Expanding Scope for Accelerated Drug Reviews
FDA; National Priority Voucher; CNPV; Martin Makary; priority review; accelerated drug approval; 2025 pilot program; voucher recipients; public health crisis; domestic drug manufacturing
Recent Advances and News in In Vivo Therapeutic Technologies (2025)
in vivo CAR-T; cell therapy; gene therapy; RNA delivery; autoimmune disease; oncology; nanoparticle delivery; drug delivery innovation; FDA fast track; biotech acquisitions