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Results For "European-Union"

255 News Found

Merck receives positive European Union CHMP opinion for Gefapixant
News | July 22, 2023

Merck receives positive European Union CHMP opinion for Gefapixant

The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union


Japan okays new long-acting eye drug
News | March 24, 2026

Japan okays new long-acting eye drug

It promises fewer injections for vision loss patients


Bristol Myers Squibb scores major win with new Opdivo nods for Hodgkin Lymphoma in US, EU
News | March 21, 2026

Bristol Myers Squibb scores major win with new Opdivo nods for Hodgkin Lymphoma in US, EU

These approvals represent a defining moment for people living with classical Hodgkin Lymphoma


Shionogi launches global Phase 2 trial for late-onset Pompe disease treatment
Clinical Trials | March 21, 2026

Shionogi launches global Phase 2 trial for late-onset Pompe disease treatment

Esprit is a multicenter, randomized, placebo-controlled, double-blind study assessing the safety, pharmacodynamics, and preliminary efficacy of S-606001 as a substrate reduction therapy


EU clears AstraZeneca’s Imfinzi combo for early gastric & GEJ cancers
News | March 17, 2026

EU clears AstraZeneca’s Imfinzi combo for early gastric & GEJ cancers

AstraZeneca says the approval strengthens its push to bring immunotherapy earlier into cancer treatment, where long-term cures are possible


EU unveils draft guidance to fast-track clinical trials during public health emergencies
Policy | March 09, 2026

EU unveils draft guidance to fast-track clinical trials during public health emergencies

The document, published under the Accelerating Clinical Trials in the EU (ACT EU) initiative, sets out how trials should be conducted when health emergencies disrupt normal research operations


Moderna wins EU backing for world’s first combined flu-COVID shot
News | March 02, 2026

Moderna wins EU backing for world’s first combined flu-COVID shot

The decision marks a pivotal moment for the Massachusetts-based biotech giant


Eli Lilly and Incyte score key win for teens with severe alopecia areata in Europe
News | February 28, 2026

Eli Lilly and Incyte score key win for teens with severe alopecia areata in Europe

AA, a chronic immune disease, can cause extensive and unpredictable hair loss


BioVersys’ novel TB drug shows promising results in Phase 2a Trial
Clinical Trials | February 23, 2026

BioVersys’ novel TB drug shows promising results in Phase 2a Trial

The clinical program has benefited from extensive European Union support, including the IMI2 TRIC-TB and UNITE4TB projects, as well as funding from the EDCTP2 bEto-TB project