Eisai (ESAIY) and Biogen (BIIB) announced an update on the ongoing regulatory review of the Marketing Authorization Application, MAA, for ...

The European Commission approves RHHBY's Columvi combo to treat adult patients with diffuse large B-cell lymphoma after ...

The agency’s Committee for Medicinal Products for Human Use said Lilly can ask for a re-examination of its opinion. Lilly said Friday that it hopes discussions about the drug continue with the ...

The agency’s Committee for Medicinal Products for Human Use said Lilly can ask for a re-examination of its opinion. Lilly said Friday that it hopes discussions about the drug continue with the agency ...

The European Commission (EC) has granted approval for AstraZeneca's Imfinzi plus chemotherapy for treating resectable NSCLC ...

The European Commission approves AstraZeneca's Enhertu for a new breast cancer indication while also expanding Imfinzi label ...

Halozyme Therapeutics (HALO) announced that Bristol Myers Squibb (BMY) received a positive opinion from the Committee for Medicinal Products ...

CHMP recommends approval for Averoa’s Xoanacyl, an oral therapy for chronic kidney disease: Grenoble, France Friday, April 4, 2025, 12:00 Hrs [IST] Averoa, a biopharmaceutical c ...

Accord received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for ...

With the latest approval, Vertex's Kaftrio is now eligible to treat about 4,000 people living in the EU with rare mutations ...

Eisai & Biogen announce update on regulatory review of MAA for lecanemab to treat early Alzheimer’s disease by European Commission: Tokyo Wednesday, April 16, 2025, 11:00 Hrs [I ...