The designation was based on the therapy’s novel mechanism and data showing its anti-tumour activity in B-cell malignancies.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Gilead ...

The European Medicines Agency has recommended authorizing a twice-yearly injectable drug to prevent HIV. LONDON (AP) — The ...

European regulators said that Eli Lilly’s Alzheimer’s treatment Kisunla should be approved for select patients.

Eli Lilly said on Friday that the European Medicines Agency (EMA) has recommended approval of its drug Kisunla for certain ...

The EU's medicines regulator said it would approve the treatment for a limited group of patients, citing concerns over side effects ...

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

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

"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 ...

The European Medicines Agency will review GSK's request to approve its asthma drug Nucala as an additional treatment for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype ...

Separately, Sareptea said last week that it would pause the development of most of its experimental gene therapies for a different type of muscular dystrophy. The stoppage came after one of the ...

The European Medicines Agency (EMA) recommended in its April meetings approval of marketing authorizations for two orphan medicines: Alyftrek for the treatment of cystic fibrosis and Attrogy for ...