The regulator is allowing the firm to submit data on 4D-150 from a single Phase III trial and draw on readouts from previously conducted studies in wet AMD.

CAMBRIDGE, MA / ACCESS Newswire / July 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission ...

Reports second quarter revenues of $0.1 billion, GAAP net loss of $(0.8) billion and GAAP EPS of $(2.13) Updates 2025 ...

In May 2025, Praxis provided an update on the EMBOLD cohort 1 study group in SCN2A and SCN8A DEEs, showing patients in the open-label extension up to 11 months had a ~90% reduction in seizures from ...

Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical ...

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Medicines Agency (EMA) has ...

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

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 EMA grants orphan designation status to medicines intended for the treatment, prevention or diagnosis of life-threatening or chronically debilitating diseases affecting fewer than 5 in 10,000 ...

The EMA grants orphan designation status to medicines intended for the treatment, prevention or diagnosis of life-threatening or chronically debilitating diseases affecting fewer than 5 in 10,000 ...