Eisai and Biogen’s marketing application for Alzheimer’s disease therapy Leqembi will face an independent advisory committee convened by the EMA before a decision is made
Manufacturing problems have scuppered Astellas’ chances of approval in the US this month for zolbetuximab, currently leading the field among Claudin 18.2-targeted drug can
Digital health company Click Therapeutics has won an FDA breakthrough device designation for CT-155, a digital therapeutic (DTx) for the negative symptoms of schizophrenia
The UK medicines regulator has launched its mutual recognition framework for authorising medicines in a move that it says will help to bring new drugs to patients in the U
Checkpoint Therapeutics’ late entry into the PD-1/PD-L1 inhibitor category, cosibelimab, just got knocked back even further after it was turned down by the FDA as a treatm