Infectious Disease

CHMP endorses Pfizer-BioNTech’s updated Covid-19 vaccine

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended marketing authorisation for Pfizer and BioNTech’s LP.8.1-adapted monovalent Covid-19 vaccine.

FDA approves Hikma’s Tyzavan for multiple infections

The US Food and Drug Administration (FDA) has granted approval for Hikma's Tyzavan (Vancomycin Injection, USP), a ready-to-infuse vancomycin formulation.

Evotec secures $2.5m grant for TB treatment development

German life science company Evotec has been awarded a $2.5m grant from The Gates Foundation (GF) to enhance the development of tuberculosis (TB) treatment regimens.

Valneva submits application seeking FDA approval for IXCHIQ for adolescent use

Valneva has submitted an application to the US Food and Drug Administration (FDA) seeking approval for a label extension of its chikungunya vaccine, IXCHIQ.

Novavax announces availability of Covid-19 vaccine in US pharmacies

Novavax has announced the availability of its updated Covid-19 vaccine, known as NVX-CoV2705, at major pharmacy retailers throughout the US.

Novavax’s updated Covid-19 vaccine receives FDA emergency use authorisation

Novavax has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its updated Covid-19 vaccine for individuals aged 12 years and over.

Moderna’s RSV vaccine mRESVIA gains EC approval

The European Commission (EC) has granted marketing authorisation for Moderna's mRESVIA (mRNA-1345) vaccine, designed for protecting individuals aged 60 and above from lower respiratory tract disease which is caused by RSV infection.

EMA CHMP recommends marketing authorisation for Moderna’s RSV vaccine

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of marketing authorisation for Moderna's mRESVIA (mRNA-1345) vaccine for adults aged 60 and above.

FDA approves ViiV Healthcare’s Dovato for adolescent HIV treatment

The US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Dovato (dolutegravir/lamivudine) to treat HIV-1 infection in adolescents.