FDA backs first COVID-19 test with home collection option

The FDA has backed the first COVID-19 diagnostic with a home collection option, at a time when the US is struggling to keep pace with the pandemic and suffering from a shortage of tests.

Seattle Genetics snags early approval for advanced breast ca...

The FDA has approved Seattle Genetics' breast cancer drug Tukysa (tucatinib) four months early, including in certain patients whose disease has spread to the brain.

Regeneron’s Ebola drug heading for October verdict from FDA

FDA delays decision on Roche's SMA drug to review extra data

The FDA has extended its review of Roche’s spinal muscular atrophy (SMA) drug risdiplam after the pharma submitted additional data.

FDA lets off Novartis after gene therapy data row

Novartis is off the hook following the FDA’s review of data manipulation in the filing of its hugely expensive spinal muscular atrophy gene therapy Zolgensma.

FDA grants emergency use of malaria drugs against COVID-19

The FDA has approved emergency use of malaria drugs championed by president Donald Trump for use in patients hospitalised with COVID-19, after warning against the potentially lethal consequ