AstraZeneca PLC (NASDAQ: AZN) and Amgen Inc. (NASDAQ: AMGN) have reported Phase 3 findings showing that IMFINZI (durvalumab) combined with IMDELLTRA (tarlatamab-dlle) reduced the hazard of death by 58% compared with IMFINZI alone as first-line maintenance treatment for extensive-stage small-cell lung cancer. Presented at the European Society for Medical Oncology Congress 2026 on October 24
Pfizer’s TUKYSA gained first-line HER2-positive breast cancer maintenance approval after extending median PFS by 8.6 months.
Cerevance’s solengepras has met the primary endpoint in the Phase 3 ARISE trial, reducing daily Parkinson’s OFF time by 0.61 hours versus placebo while also improving ON time and daily motor function. The result validates a novel GPR6-based, non-dopaminergic approach, but the absolute effect was smaller than in Phase 2 and arrives just as AbbVie
FDA approves Novartis Rhapsido as the first treatment specifically for symptomatic dermographism after positive Phase III RemIND results.
Cerevance’s solengepras cuts Parkinson’s OFF time and improves daily motor function in a positive Phase 3 trial ahead of FDA discussions.
The FDA has approved Elevar Therapeutics’ Lyrfigtu for previously treated FGFR2-rearranged cholangiocarcinoma after a 46% response rate and 11.8-month median response duration. The drug enters an established targeted market, making FGFR2 selectivity, tolerability, molecular testing and eventual activity against resistance mutations more important than simply being another approved inhibitor.
Celldex Therapeutics has delivered positive results from both Phase 3 EMBARQ studies of barzolvolimab in chronic spontaneous urticaria, with roughly 42% to 46% of treated patients completely free of hives and itch by Week 12 and response rates deepening through Week 24. The clinical programme also produced substantial activity after omalizumab failure and against angioedema,
ORKA-001 reaches 71.4% complete psoriasis clearance at Week 28 without redosing. See what the data mean for Oruka’s long-acting biologic strategy.
Amgen’s dazodalibep has met the primary endpoint in the Phase 3 OASIZ 301 study, improving systemic Sjögren’s disease activity as early as Week 4 and sustaining the benefit through Week 48. The result is a major step in a disease with no FDA-approved systemic treatment specifically for Sjögren’s, but Amgen has not yet disclosed the
BioNTech and OncoC4 have reported median overall survival of 18.5 months with gotistobart versus 10 months with docetaxel in previously treated squamous non-small cell lung cancer. The result revives interest in CTLA-4 immunotherapy after PD-1 or PD-L1 treatment failure, but it came from the non-pivotal first stage of PRESERVE-003, leaving a much larger global cohort