Drug Approval | January 12, 2026
FDA rejects Vanda’s jet lag drug in current form
Vanda strongly disputes the FDA’s reasoning
Vanda strongly disputes the FDA’s reasoning
InflaRx is streamlining operations and largely discontinuing non-essential activities outside izicopan’s development
KRAS G12C-mutant advanced or metastatic nonsquamous non-small cell lung cancer
The FDA designation follows visual-function results from the Phase 2 ACUITY trial
The approval is backed by data showing deep, durable responses and manageable tolerability
The approval follows robust data from the SWIFT and ANCHOR Phase III trials
Receiving Orphan Drug Designation is an important milestone in the clinical development of CK0804 for myelofibrosis
The therapy was well tolerated through Week 24, with a safety profile consistent with Alumis’ Phase 2 data
The work will leverage ProBioGen’s CHO.RiGHT expression platform, powered by its proprietary DirectedLuck transposase technology, alongside PsiBot smart automation
SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage
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