FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market.
Dosing can start once again in uniQure's phase 3 trial of its haemophilia B gene therapy, after the FDA concluded that a case of liver cancer seen in the study was unlikely to be caused by
The FDA has approved GlaxoSmithKline’s Jemperli (dostarlimab) immunotherapy, a drug acquired through its $5.1 billion acquisition of Tesaro, for certain patients with endometrial cancer.
Emergent BioSolutions' difficult month has been made worse by an FDA report into its facility in Baltimore, which has been blamed for the wastage of millions of doses of Johnson & Johns
A phase 3 trial of Romark's antiviral drug NT-300 has missed the main objective in a phase 3 trial in mild to moderate COVID-19 patients, but could still have a shot at emergency use author
US health authorities have recommended pausing dosing with Johnson & Johnson's COVID-19 vaccine as they investigate cases of blood clots also observed in some people taking the AstraZen