FDA grants breakthrough status to Biogen’s litifilimab for CLE
This designation aims to expedite the development and review of medicines for serious conditions. The FDA based its decision on comprehensive data, including findings from the Phase II
The partnership will leverage Insilico’s Pharma.AI platform for the development of small molecule inhibitors, with the agreement valued at nearly $120m. This agreement includes development and commercial milestone
The International Nonproprietary Names (INN) approved the generic name zavabresib for OPN-2853. Myelofibrosis is a rare blood cancer involving bone marrow scarring, resulting in anaemia, severe fatigue, ineffective
The collaboration, which began in 2023, aims to create therapies that can replace, repair, or supplement biological functions in patients, advancing the development of disease-modifying treatments. Under the
Ianalumab is a fully human monoclonal antibody that targets B-cells and inhibits their activation and survival by blocking B-cell activating factor receptor (BAFF-R). Novartis intends to submit ianalumab
The collaboration secures funding and sustained biologics manufacturing capacity in the US for Agenus, supporting clinical development, early access initiatives, and future commercial production. Under the agreement, Agenus
The application sought approval for Ebvallo as monotherapy in adult and paediatric patients aged two years and above with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD), who have