Archive
594 articles, sorted by publication time.
FDA pre-advisory meeting documents did not show major review gaps, giving Moderna’s mRNA flu vaccine a renewed possibility of approval; but age stratification, protective benefit, and short-term reactogenicity will still determine whether this platform can take a key step beyond COVID-19 vaccines.
uniQure has been cleared to advance review using existing early- and mid-stage data and three-year follow-up data, opening a shorter but still highly uncertain regulatory path for a rare neurodegenerative disease therapy.
A Hokkaido University team reports that whether cells survive after whole-genome doubling depends not only on the increase in DNA itself, but also on the stage at which division failure occurs. This cell-level study offers a finer lens for observing cancer recurrence and chromosomal instability.
A structural biology study redraws seemingly loose molecular droplets inside cells as miniature architecture with scaffolds, shapes, and functional consequences; it opens new ways to imagine cancer and neurodegenerative diseases, but the road to drugs remains long.
FDA records show that after this subcutaneous version of Keytruda received marketing approval in 2025, its label continued to be adjusted through supplemental applications in 2026; beyond the clinical appeal of rapid administration, regulatory attention is turning to how immune-related risks are more clearly written into prescribing information.
EGFR-mutant lung cancer already has powerful targeted therapies, yet it remains difficult to know in advance who will relapse and by what mechanism the disease will escape treatment; a new public benchmark dataset is turning this clinical challenge into a testable AI problem.
A Princeton team grew human nerve cells in a three-dimensional electronic mesh, allowing cells and device to jointly complete a pattern-recognition task; this is not a signal that “living computers” are about to replace chips, but it does bring neural tissue, microelectronics, and disease models closer together.
An arXiv analysis that has not yet undergone peer review shifts the focus from the results of a single trial to how an entire body of clinical evidence is generated. For biosimilars, which rely on comparative studies to build trust, such questions, even if not yet conclusive, are enough to remind regulators and the medical community to re-examine data traceability.
This is not a victory narrative for a single star drug, but a regulatory timetable: multiple oncology and immunotherapy products completed efficacy or label supplemental approvals on the same day, reflecting how large drugmakers extend product life cycles through detailed label updates.
FDA data show that Merck’s Keytruda received a supplemental efficacy approval for a new indication on June 12; before the official details have been fully laid out, this record first marks another update to the oncology treatment label.
A small-molecule drug designed specifically for essential tremor has moved from the uncertainty of clinical trials to FDA review; whether it can reshape a treatment landscape that has long had limited options could be revealed as early as early 2027.
India has approved AstraZeneca and Daiichi Sankyo's antibody-drug conjugate Enhertu for first-line treatment of certain HER2-positive advanced breast cancer, further bringing a drug already closely watched in the global oncology market into India's large clinical setting.