"Tevimbra is already approved in the EU across multiple settings in [non-small cell lung cancer], the most common form of lung cancer, and this positive CHMP opinion expands its potential to help ...

Recommendation based on Phase 3 RATIONALE-315 study, in which TEVIMBRA demonstrated clinically meaningful and statistically significant improvement in event-free survival and major pathological respon ...

The European Medicines Agency (EMA) has granted limited approval to Eli Lilly’s (LLY) new Alzheimer’s drug Kisunla, reversing ...

The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.

The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing HIV, which ...

The European Union's drug regulator has recommended approval of Moderna's updated formulation of COVID-19 shot Spikevax, the ...

The European Medicines Agency (EMA) cleared the way for the use of another drug to treat Alzheimer's disease on Friday.

Preliminary data from clinical trials of tecovirimat as a treatment for mpox virus infection have given disappointing results ...

The agency weighed safety data and a new dosing regimen to recommend approval of the treatment for early Alzheimer's disease in certain patients.

Eli Lilly and Co. won the backing of European Union regulators for its Alzheimer’s disease drug Kisunla in a specific group ...

Lilly’s appeal of an earlier, negative recommendation from a key EMA committee has worked out in its favor, and puts the drug ...

The European Union's drugs regulator has recommended approval of Gilead Sciences' lenacapavir, a twice-yearly injection, for ...