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
GRAIL shares recorded their strongest session in more than a year after FDA reviewers raised no major analytical or primary safety concerns ahead of a September 23 advisory committee vote on Galleri, the blood test designed to screen adults for signals from more than 50 cancers.
The European Commission has approved Roche’s Susvimo implant for neovascular age-related macular degeneration, offering continuous ranibizumab delivery with refills every six months and creating a fundamentally different alternative to repeated eye injections.
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
XORTX Therapeutics shares climbed 15.7% as trading volume surged above seven million shares after the company outlined plans to file an FDA IND for XRx-026 in the fourth quarter, but funding requirements remain a critical part of the development story.
Japan has approved the Leqembi Pen for once-weekly at-home administration in early Alzheimer’s disease, potentially reducing infusion-center dependence while giving Biogen and Eisai another way to differentiate lecanemab from rival anti-amyloid therapies.
Electra Therapeutics has raised $350 million in one of 2026’s larger biotechnology IPOs, giving the clinical-stage company enough projected capital to reach pivotal results for ipsoprubart in secondary hemophagocytic lymphohistiocytosis. The stock’s 11.7% first-day decline shows that investors remain cautious, however, because the company’s most striking efficacy evidence still comes from a small uncontrolled Phase
Aquestive Therapeutics has resubmitted its Anaphylm application after responding to FDA concerns over packaging and administration, putting the potential needle-free, orally delivered emergency treatment for anaphylaxis back on a regulatory path toward the U.S. market.
European regulators have backed Tecvayli monotherapy after only one prior multiple myeloma treatment, potentially transforming Johnson & Johnson’s BCMA bispecific from a late-line therapy into a much larger second-line franchise.
Teva Pharmaceutical Industries has reported new long-term data for once-monthly subcutaneous TEV-’749 ahead of an expected fourth-quarter FDA decision. Its competitive proposition is not a new antipsychotic mechanism, but an attempt to combine established olanzapine efficacy with long-acting dosing without the post-injection monitoring burden that has constrained the existing olanzapine depot.