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
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Takeda GmbH’s live, attenuated dengue tetravalent vaccine, Qdenga
A pilot study has been launched by the EMA to see whether it is helpful for regulators to look at the 'raw data' from clinical trials submitted in support of new marketing application along