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Interferon (IFN)-α has reigned supreme for decades as biotech's blockbuster antiviral. That looks set to change with a raft of antibody and nucleic acid therapies progressing through the pipeline.
The newly passed US Food and Drug Administration's (FDA) Amendments Act (FDAAA) sets the stage for key improvements to postmarketing surveillance as well as the preapproval process.
To what extent did the French government's failure to publicly disclose the exact location of field trials contribute to the suicide of a farmer hounded by anti-GM activists?
More definitive answers about the death of a woman in an adeno-associated virus (AAV) gene therapy trial for arthritis must await a meeting of the Recombinant DNA Advisory Committee (RAC) later this month.
The example set by leading proteomics laboratories will be a major factor in determining the successful implementation of new reporting guidelines in the wider community.
Despite hand-wringing over the patenting of a minimized organism, both patents and open-source approaches will be needed to promote innovation and research progress in synthetic biology.
The thinking behind the US Food and Drug Administration's (FDA) draft guidance on financial conflicts of interest for outside experts is deeply flawed.
The nonprofit Pew Initiative on Food and Biotechnology is closing, but the need for an independent and neutral body to facilitate dialog on US biotech policy has never been greater.
A think tank and an investment bank have proposed solutions to address the lack of funding to carry biotech companies through the early stages of clinical development.