2024 saw the highest number of biosimilars approved by the US Food and Drug Administration (FDA) in a calendar year, with this yea...
Johnson & Johnson's (J&J) human neonatal Fc receptor (FcRn)-blocking monoclonal antibody Imaavy (nipocalimab-aahu) has rec...
The US Food and Drug Administration (FDA) has added haemodialysis bloodlines to its medical device shortages list amid supply disr...
The US Food and Drug Administration (FDA) has issued an early alert over a ‘potentially high-risk’ issue with certain Baxter S...
ImmunityBio has gained US Food and Drug Administration (FDA) authorisation for an expanded access programme to supply an alternati...
More than 13 years after its initial FDA approval, Pfizer’s blood cancer drug Adcetris has nabbed another regulatory green light...
Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of Parkin...
The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Ozempic (semaglutide) to reduce certain risks associated...
Mesoblast has gained US Food and Drug Administration (FDA) approval for its mesenchymal stromal cell (MSC) therapy, Ryoncil (reme...
The US Food and Drug Administration (FDA) has stood by an earlier decision confirming that the tirzepatide shortage is over. Th...