Breaking News
- Praxis Precision’s Tremor Drug Trial Success: Praxis’s ulixacaltamide met endpoints in two Phase 3 trials for essential tremor, marking one of the first major late-stage wins in the indication. MarketWatch
- EO2463 Receives Fast Track Designation: Enterome’s OncoMimics-based immunotherapy demonstrated 46% ORR in interim Phase 2 results in follicular lymphoma, earning FDA Fast Track. Targeted Oncology
- TECVAYLI + DARZALEX FASPRO Combo Improves Survival: The MajesTEC-3 Phase 3 study showed improved PFS and OS in relapsed/refractory multiple myeloma. PR Newswire
Industry Trends & Policy Updates
- FDA Launches National Priority Voucher Program: First vouchers awarded to nine sponsors on Oct 16, 2025, incentivizing R&D in priority health areas. FDA
- NIH $2M Grant to EVOQ Therapeutics: To advance NanoDisc-based therapies for celiac disease and autoimmune disorders. BioSpace
- AbbVie’s RINVOQ Label Expanded for Earlier IBD Use: FDA now allows use prior to TNF blockers for ulcerative colitis and Crohn’s. AbbVie News
- Orphan Drug Designation Surge: Over 850 orphan drugs in development; FDA grants new rare-disease designations in IPF and glioblastoma. GlobeNewswire
Approvals & Label Expansions
- Lurbinectedin Combination Approval: Expanded indication for maintenance use with atezolizumab in extensive-stage SCLC. Wikipedia
- Cemiplimab Adjuvant Approval: FDA approves for adjuvant use in high-risk cutaneous squamous cell carcinoma post-surgery/radiation. Wikipedia
Summary
| Category | Key Highlights | Links |
|---|---|---|
| Breaking News | Praxis Phase 3 tremor win; EO2463 Fast Track; TECVAYLI + DARZALEX combo PFS/OS benefit | Praxis | EO2463 | MajesTEC-3 |
| Industry Trends | FDA National Priority Vouchers; EVOQ NIH grant; RINVOQ label expansion; Orphan drug surge | FDA Vouchers | EVOQ Grant | RINVOQ | Orphan Trends |
| Approvals | Lurbinectedin combo in SCLC; Cemiplimab adjuvant for cSCC | Lurbinectedin | Cemiplimab |
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