EMA

The long-acting therapy, also known as nirsevimab, was given the European Union (EU) marketing authorisation for the prevention of…

The agency also authorised Pfizer-BioNTech's and Moderna's vaccines for children as young six months

The company intends to file for regulatory approval in the EU in the next few months

Lenacapavir is an investigational, long-acting capsid inhibitor for the treatment of HIV-1 in people with limited therapy options

While many patients will benefit from available TKI therapies, a significant proportion may experience intolerance or resistance…

The US-based Moderna's so-called bivalent vaccine targets two strains of the SARS-CoV-2 virus behind COVID, the original strain…

The companies also plan to submit these data to the European Medicines Agency (EMA) and other regulatory agencies around the world…

Valneva said the EMA Committee for Medicinal Products for Human Use (CHMP) had a fresh list of questions, including requests for…

The shot is also the sixth COVID-19 vaccine to be approved in the UK

The pledge would reduce the time patients wait for new medicines by four-to-five months in several countries such as Bulgaria,…