NEXSPIKE is Moderna’s third product to receive a positive CHMP opinion alongside Spikevax (COVID-19 Vaccine, mRNA) and ...

NEXSPIKE is Moderna's third product to receive a positive CHMP opinion alongside Spikevax (COVID-19 Vaccine, mRNA) and mRESVIA (Respiratory Syncytial Virus Vaccine)mNEXSPIKE will be available in the E ...

Merck secures a positive CHMP opinion to expand Winrevair's PAH use, potentially broadening treatment to adult patients ...

The European regulator has recommended marketing approval for Ranluspec and Gotenfia after studies confirm their safety, ...

Phase 3 studies point to sustained disease control in patients who remain symptomatic despite standard therapies.

Moderna on Monday said that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the marketing authorization of mNexspike, a new Covid-19 vaccine. The committee's ...

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the ...

The CHMP recommendation for MYQORZO is based on the positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine, which demonstrated robust ...

AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union (EU) for subcutaneous self-administration as a pre-filled pen for adult patients with systemic lupus erythematosus (SLE) on ...

Final Decision from European Commission Expected in Q1 2026SOUTH SAN FRANCISCO, Calif., (GLOBE NEWSWIRE) -- Cytokinetics, ...

Novo Nordisk NVO announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) ...

FDA approves AstraZeneca and Daiichi's Enhertu combo for first-line HER2-positive breast cancer, while the EU clears Saphnelo ...