Biogen and Eisai have said that the EMA's human medicines committee looks unlikely recommended approval of their Alzheimer's drug Aduhelm when it comes up for discussion next month.
Shares in France's Valneva leaped after it got an EU order to supply 60 million doses of its COVID-19 vaccine VLA2001 over the next two years, including 27 million next year.
Companies looking to replicate a drug’s EU market success in the US will face significant hurdles unless they are fully aware of the ever-changing national and state requirements and regula
Incyte and MorphoSys' antibody therapy tafasitamab has been approved in Europe, promising to provide a more convenient alternative to expensive and cumbersome CAR-T therapies for patients w
The FDA may be reluctant to trust JAK inhibitors, but the European Commission is more willing, and has just handed a first-in-class approval in atopic dermatitis to AbbVie's Rinvoq.
UCB has been bringing up the rear in the IL-17 inhibitor category with bimekizumab, but now has EU approval for the drug and thinks it can mount a stiff challenge to the leaders, including