News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Just months after facing a rejection in the US, the bispecific antibody odronextamab (Ordspono) has been approved by the European Commission for the treatment of two types of blood cancer in patients that have failed to respond to previous treatments.
Microbiotica has received the green light from EU and UK regulatory authorities to start phase 1b studies for its microbiome medicines in advanced melanoma and ulcerative colitis.
The US FDA has granted emergency use authorization to several updated COVID-19 vaccines against a new viral strain that is currently circulating.