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...
After its market withdrawal in 2022, GSK’s multiple myeloma drug Blenrep (belantamab mafodotin) is poised to re-enter the treat...
Disc Medicine has announced a US Food and Drug Administration (FDA) agreement on the regulatory path for its investigational drug...