Amlenetug is tailored to attach to all major extracellular α-synuclein forms. The human monoclonal antibody aims to prevent ...

Scientific publications and reach in the field have shown already that post-injury angiogenesis and vascular remodeling ...

Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today an ...

UCART22 Phase 1 dataset and late-stage development strategy expected in the third quarter of 2025; Orphan Drug Designation (ODD) and Rare ...

The Ministry of Health, Labor, and Welfare (MHLW) in Japan has granted Orphan Drug Designation (ODD) to Lundbeck’s investigational drug, amlenetug, a potential new treatment option targeting Multiple ...

Rare Disease Day at IndoUSrare - Bridging Nations, Empowering RARE Lives Dr. Harsha Rajasimha with Jenifer Waldrop at the RDDC RISE Awards ...

Lundbeck’ amlenetug receives Japanese orphan drug designation for treatment of multiple system atrophy: Denmark Tuesday, March 11, 2025, 11:00 Hrs [IST] H. Lundbeck A/S (Lundbec ...

The results show that HTAs for orphan drugs can vary widely across Europe, causing inconsistencies in evidence requirements and recommendations. The study reviewed all 80 European Medicines Agency ...

Europe’s drug regulatory agency has given Kizfizo a negative opinion for the second time, following one from November 2024.

There have been continued calls to reform orphan drug legislation in the US and the EU, particularly the 40-year-old Orphan Drug Act and the European Union's 1999 Orphan Drug Regulation.

The Ministry of Health, Labor, and Welfare (MHLW) in Japan has granted Orphan Drug Designation (ODD) to Lundbeck's investigational drug, amlenetug ...