Novartis as opted out of a collaboration with Mesoblast to develop its stem cell-based therapy remestemcel-L as a treatment for COVID-19, prompting a slump in the biotech's share price.
The FDA has rejected Mesoblast’s Ryoncil cell therapy for children with graft versus host disease, despite a recommendation to approve from a panel of expert advisers.
Australian biotech Mesoblast can go ahead with a US filing for its off-the-shelf stem cell therapy for acute graft-versus-host disease (GVHD), after negotiations with the FDA.
The EMA's human medicines committee has recommended against approval of Eisai and Biogen's Alzheimer's disease therapy Leqembi, after regulators in the US, China and Japan gave a green ligh