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A panel of independent experts voted narrowly in favour of continuing to require cardiovascular outcomes data for new diabetes drugs, but urged relaxation and simplification of the safety assessment.
Johnson & Johnson has submitted its esketamine for regulatory approval, but researchers still don't understand how the fast-acting antidepressant lifts moods.
Nanodroplets promise to reduce the equipment, cost and time constraints of high-throughput screening, if researchers can overcome long-standing hurdles.
With the FDA's approval of GlaxoSmithKline's tafenoquine, global health experts will at last have access to a long-awaited new treatment forPlasmodium vivax recurrence. Much-needed novel treatments for the more common Plasmodium falciparumare in phase II trials.
Ongoing and upcoming clinical trials of metformin, mTOR inhibitors and senescent cell-killing drugs could prove that ageing and ageing-related diseases are viable drug discovery indications.
Constrained peptides have long tantalized drug developers with their potential ability to combine the best attributes of antibodies and small molecules. Finally, a handful of constrained peptides are in late-stage clinical trials.
Amgen's erenumab recently secured FDA approval as the first G protein-coupled receptor-targeted antibody. More of these biologics are on the way, despite remaining challenges.
Two immune-boosting strategies have independently indicated promise in sepsis clinical trials, after years of failures with anti-inflammatories in this same space. Will it be enough to take sepsis drug development out of 'critical condition'?
Many drugs unexpectedly influence the human gut microbiome, showed a recent study, prompting questions about toxicity assays, clinical implications and repurposing opportunities.
Denali Therapeutics is taking a swing at neuroinflammation with a first-in-man trial of a RIPK1 inhibitor, while the company and others search for ways to target microglial biology more precisely.
The FDA could soon approve the first drug developed explicitly for a tissue-agnostic cancer indication, but biological complexity may limit this approach.
With Alnylam's rare disease drug candidate patisiran nearing the regulatory finish line, the RNA interference community is now turning its attention to next-generation delivery technology to solidify the future of the emerging modality.
A pioneering Merck & Co.-funded study is set to explore the ability of the microbiome to boost immuno-oncology therapy outcomes, and other companies are quickly gearing up to enter this clinical space.