The active pharmaceutical ingredient (API) landscape is shifting. Companies are rethinking their sourcing strategies, upgrading th...
The US Food and Drug Administration’s (FDA) scrutiny around medical device cybersecurity will “intensify significantly” as w...
Cell and gene therapies (CGT) offer hope to patients living with life-threatening conditions where limited treatment options may b...
Bioconjugation creates new molecules with increased stability and improved targeting. The process of joining proteins, peptides, o...
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...