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
Bayer subsidiary BlueRock Therapeutics has been granted a fast-track review by the FDA for DA01, its stem cell-based therapy for Parkinson's disease which is currently in early-stage clinic
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