Gilead has rescinded its request for orphan status for its potential COVID-19 antiviral remdesivir amid a furore over its pricing should it get to market.
Shire plans to file its lanadelumab for the rare genetic disorder, hereditary angioedema (HAE), on the back of new phase 3 data showing the drug reduces monthly swelling attacks when taken
Scott Gottlieb has been confirmed as the next FDA commissioner after Senators voted in favour of president Donald Trump’s pick to run the world’s most influential regulator.
EUSA Pharma’s dinutuximab beta has gained European approval for its immunotherapy for children affected by a rare and devastating form of cancer, a move which exploits a gap in the market l
Novartis has joined with Allergan in a bid to get ahead in the race to get a drug approved to treat the fatty liver disease, non-alcoholic steatohepatitis (NASH).
The US FDA announced today that it has cleared two novel gene therapies for sickle cell disease: Vertex Pharmaceuticals' Casgevy and bluebird bio's Lyfgenia.
On 1st October, the roll-out of the National Contract Value Review (NCVR) process marked a pivotal moment in the trajectory of clinical research in the UK, introducing a standardised, natio