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May 04, 2026
The FDA said one pivotal trial plus confirmatory evidence will become the default standard for approval of most new drugs. The shift could extend beyond rare diseases to common conditions affecting millions.
Feb 26, 2026
Early trial of Rezatapopt shows 20% response rate in advanced cancers with p53 mutations, while researchers identify AMD3100 as potential solution to enable immunotherapy in rare liver cancer.
Feb 20, 2026
Grail's multi-cancer blood test failed to significantly boost early detection or reduce late-stage diagnoses in a 142,000-person UK trial, raising doubts about regulatory approval and commercial prospects.
Feb 17, 2026
TuHURA Biosciences filed an IND application with the FDA for TBS-2025, a VISTA inhibiting antibody, to be studied in combination with a menin inhibitor for treating mutNPM1 relapsed/refractory Acute Myeloid Leukemia.
