Pharma

Regulators face new challenges over whether — and how — to allow people to receive mind-altering drugs to treat mental health conditions.

‘I cannot honestly answer why President Biden came to that conclusion,’ says chief medical officer of European Medicines Agency.

Europe’s medicines regulator has given BioNTech/Pfizer’s second Omicron-targeting COVID vaccine the green light, paving the way for shipments to EU countries immediately, the companies said in a …

European Court of Auditors accuses Commission of refusing to release details of how the bloc’s biggest vaccine contract was negotiated.

The Commission’s quality-control team gave a negative opinion to a proposed revamp of rules governing access to innovative medicines.

Countries across Europe are gearing up to launch booster campaigns with the updated shots.

The US has asked manufacturer Bavarian Nordic to test millions of doses in its stockpile that had reached the end of their shelf life.

There is limited data on the efficacy of the vaccine, and what is available has been drawn from animal studies.

All adults and children aged five and over with learning disabilities will be eligible for a booster this fall.

The government argues data on the duration of protection against Omicron is insufficient.

Despite most monkeypox deaths occurring in Africa, the continent has yet to receive any vaccines.

Health emergencies authority isn’t agile enough, according to companies and countries.

European regulator is still assessing the jab.

Vaccine developers need to satisfy both US and European demands, a strategy that risks fueling hesitancy.

Public health groups want the EU to sync its response this year, but the bloc’s infectious disease agency has pushed back.

Such a label risks hampering the bloc’s climate ambitions, the industry argues.

The European Ombudsman issued recommendations for preserving texts after so-called “Delete-gate.”

Italy and the city of Milan had contested its relocation.

Waiting for variant vaccines in the fall will not protect people now from the new surge in COVID-19 cases and hospitalizations, ECDC chief says.

BioNTech and Pfizer Friday announced they had submitted data to the European Medicines Agency backing their three-dose COVID-19 vaccine for children aged 6 months to less than …

Brussels is eyeing the UK’s post-Brexit approach to solving cell and gene therapy headaches.

The agreement, called a ‘data adequacy decision,’ is the UK’s first since it took control of its own data policy after leaving the EU.

Brussels responds to Ombudsman’s maladministration finding in Delete-gate controversy over vaccine texts.