The EMA has launched a consultation on the circumstances in which single-arm trials (SATs) – those without a control group – can be used to support marketing applications
Eisai and Biogen have moved swiftly ahead with regulatory filings for their new Alzheimer's therapy lecanemab in the EU, after getting a green light for the anti-amyloid beta antibody in th
The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talqueta
Two years ago, the EMA proposed a set of recommendations to unlock the potential of big data for public health, headlined by the creation of a platform to access and analyse healthcare data
The EMA has delivered some good news to GSK on a new long-acting HIV drug and vaccine for respiratory syncytial virus (RSV), in a week that saw multiple disappointments in other R&D pro