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
Bayer's big investment in time and money on the development of finerenone for chronic kidney disease (CKD) in diabetics has paid off with an FDA approval, although it could face stiff compe
In another twist to the Aduhelm approval tale, FDA's Janet Woodcock has called for an independent investigation into the relationship between agency staffers and Biogen executives.