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 •  October 12

Advisers to the US Food and Drug Administration (FDA) have paved the way for the agency’s first approval of a gene therapy to treat a disease caused by a genetic mutation. On 12 October, a panel of external experts unanimously voted that the benefits of the therapy, which treats a form of hereditary blindness, outweigh its risks. The FDA is not...

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 •  May 25

The US Food and Drug Administration (FDA) has issued its first approval of a cancer drug that targets tumours with specific mutations, regardless of where in the body the tumour first took root. This deviates from the agency’s previous approach: although a drug’s use may have been linked to the presence of a particular molecular marker, the FDA...

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 •  May 11

Those who submit faked clinical trial data might now go to jail — and in extreme circumstances, be executed — under a new interpretation of China’s criminal code, announced last month. The policy shift is one of a handful of measures that China is implementing both to speed up its notoriously slow drug-approval process and to keep dangerous and...

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 •  May 4

Clinicians have long known that microbes such as bacteria, viruses and fungi are becoming alarmingly resistant to the medicines used to treat them. But a global response to this complex health threat — commonly termed 'antimicrobial resistance' — requires engagement from a much broader array of players, from governments, regulators and the public,...

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 •  March 18

For years, medical researchers have hoped that a burgeoning class of cholesterol drugs targeting a protein called PCSK9 could be the next generation of blockbuster treatments. Now, a large clinical trial has demonstrated that this approach can lower the risk of heart disease. But it’s still unclear whether these drugs — which attempt to mimic a...

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 •  March 13

President-elect Donald Trump has nominated Scott Gottlieb — a conservative pundit, physician and venture capitalist — to head the US Food and Drug Administration (FDA). Gottlieb, who serves on the board of several pharmaceutical companies, is a vocal critic of the health-care reforms instituted by former president Barack Obama. At times, he has...

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 •  March 10

President-elect Donald Trump will select Scott Gottlieb — a conservative pundit, medical doctor, and venture capitalist — to head the US Food and Drug Administration (FDA), according to media reports. Gottlieb, who serves on the board of several major pharmaceutical companies, is a vocal critic of the healthcare reforms instituted by former...

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 •  March 1

The World Health Organization (WHO) has for the first time released a list of drug-resistant bacteria that pose the greatest threat to human health — and for which new antibiotics are desperately needed. The agency's aim in listing these 'priority pathogens' is to steer funds towards development of the most crucial antimicrobials. Researchers say...

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 •  February 27

The WHO recognizes human African trypanosomiasis, Chagas disease and the leishmaniases as neglected tropical diseases. These diseases are caused by parasitic trypanosomatids and range in severity from mild and self-curing to near invariably fatal. Public health advances have substantially decreased the effect of these diseases in recent decades but...

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 •  February 14

The first clinical trials are starting in West Africa to test whether transfusing patients with plasma or blood donated by Ebola survivors is safe and effective in reducing illness and death. The hope is that antibodies against Ebola that are present in survivors’ blood might have a protective effect in those infected with the virus. Although some...