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The long development of RTS,S, the leading malaria vaccine candidate, has yielded preliminary positive Phase III results, and laid a path for future success.
An eventful year — including panel meetings, approvals and a refusal to file a new drug application — has sharpened the focus around the FDA's requirements for accelerated approval of anticancer drugs.
Over a decade since gene therapy development came to a near standstill with the death of a clinical trial participant, the field is overcoming issues of immunogenicity, carcinogenicity, manufacturing and small patient populations.
Drugs that block Janus kinases are showing promise in diseases ranging from myelofibrosis to rheumatoid arthritis, but with the leading agent in line for approval questions remain about their optimal selectivity.
Concerns about cancer risks prompted a negative vote by an FDA advisory committee on the SGLT2 inhibitor dapagliflozin, but experts remain hopeful for the novel class of antidiabetic drugs.
Bayer halts nearly two-thirds of its target-validation projects because in-house experimental findings fail to match up with published literature claims, finds a first-of-a-kind analysis on data irreproducibility.
The PI3K–AKT–mTOR pathway has long been an attractive oncology target. But with top-line results from the most advanced AKT inhibitor due soon, many questions remain over which targets to hit and how to combine agents.
Pharmaceutical–academia deals have been stealing headlines this year, but more complex models of pharma–pharma collaboration are increasingly being seen as potential solutions to industry's most intractable challenges.