ema

News

EU regulator lifts GSK amid torrid week for company's pipeli...

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

News

Mosquito is extracting blood from skin and has turned bright red

Takeda dengue vaccine receives positive CHMP opinion

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

News

Young attractive female scientist holding a red transparent pill with futuristic scientific air interface with chemical formulas and research data in the foreground

EMA pilot will see if clinical trial data should be digested...

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

Market Access

Are timely access and robust safety mutually exclusive?

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety?

News

Closeup of X-ray photography of human brain

Biogen pulls EU application for Alzheimer's drug Aduhelm

Biogen has given up on seeking approval for its Alzheimer's disease therapy Aduhelm in the EU, saying that discussions with EU regulators had made it clear the current data for the drug is

News

EU says not enough evidence to warrant fourth COVID jabs

It is too early to consider widespread use of a second COVID-19 vaccine booster dose, according to the European Centre for Disease Prevention and Control (ECDC) and EMA's COVID-19 task forc

EU regulator lifts GSK amid torrid week for company's pipeli...

Takeda dengue vaccine receives positive CHMP opinion

EMA pilot will see if clinical trial data should be digested...

Are timely access and robust safety mutually exclusive?

Biogen pulls EU application for Alzheimer's drug Aduhelm

EU says not enough evidence to warrant fourth COVID jabs

DNA testing can help right racial imbalance in breast cancer

Using AI-driven synthetic personas to take your insights fur...

ema

Editor's Picks