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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

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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?

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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

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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

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EMA sets out proposals to reform EU's clinical trials framew...

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an int

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

EMA sets out proposals to reform EU's clinical trials framew...

Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer

Discover a new era of healthcare panel engagement: Grounded ...

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