Bristol-Myers Squibb has withdrawn its US marketing approval for PD-1 inhibitor Opdivo as a second-line, single-agent treatment for hepatocellular carcinoma, a common form of liver cancer,
Novartis has revealed that the FDA has accepted its resubmission for cholesterol-lowering drug Leqvio – rejected unexpectedly by the US regulator last year – and has set a new action date o
The FDA has taken a longer than usual look at Ardelyx's regulatory submission for tenapanor, a drug for high blood phosphate levels associated with chronic kidney disease (CKD), and found i
The FDA has approved a new pneumococcal vaccine from Merck & Co, just over a month after Pfizer got a green light for a new version of its market leading Prevnar shot.
Safety concerns seem to have scuppered any hope of a near-term approval for FibroGen and AstraZeneca's roxadustat for anaemia associated with chronic kidney disease (CKD) in the US, after F
Three FDA figures at the centre of the fallout over the approval Biogen and Eisai's Alzheimer's disease therapy Aduhelm have defended their actions, arguing that to do otherwise would have