With an FDA approval submission for RegenXBio’s Hunter syndrome gene therapy already underway, the biopharma has now found a commercialization partner for both the U.S. and Asian markets.

Denali’s wholly owned program, DNL310 or tividenofusp alfa, is an Enzyme Transport Vehicle-enabled iduronate-2-sulfatase (IDS) replacement therapy in development for MPS II (Hunter syndrome).

BUCHAREST, Jan 16 (Reuters) - Romania's coalition government approved on Thursday a re-run of a two-round presidential election on May 4 and May 18 as previously agreed, and tightened campaign ...

Hunter syndrome results from the absence of an enzyme needed to break down cellular waste. Without it, waste builds up in the body, causing progressive damage to various systems.

One of the treatments, for a progressive disorder known as Hunter syndrome, could secure approval in the U.S. as soon as late ...

Denali Therapeutics Inc. DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, tividenofusp alfa (DNL310), for the treatment of individuals with Hunter ...

Romania’s Prime Minister Marcel Ciolacu announced on Monday that he and his coalition partners decided to adopt new economic ‘ordinance’ measures to address governmental budget deficit issues.

Romania and Bulgaria have become full members of the European Union’s border-free Schengen area after scrapping land border controls in the bloc. The expansion was officially introduced at ...

Only a few days left until the borders between Romania and Bulgaria close as the countries join the Schengen Area — a border-free region that guarantees the free movement of millions of EU citizens.