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
The FDA has added a new warning on the Johnson & Johnson COVID-19 vaccine, saying the shot has been linked to a serious but rare side effect – Guillain-Barré syndrome – that can cause m
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.