European Medicines Agency

Shortages of antibiotics have been reported in 26 European countries, the European Medicines Agency (EMA) says.

The statement follows recent deaths due to liver failure after treatment with the gene therapy, the EMA said

The approval facilitates availability of Vaxneuvance for this population in all 27 European Union (EU) member states plus Iceland,…

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

The drug, which has received a similar recommendation in the US in March, is a key asset for AstraZeneca

Every year, the agency adjusts its fees on 1st April, in line with the European Union (EU) inflation rate for the previous year

Celerity Pharma uses Biocon Biologics’ insulin drug substance to develop the product

It cited “a small set of additional questions” from the EMA as reason for the delay, adding it was set to respond within days