FDA to review Eisai’s Leqembi Iqlik sBLA for Alzheimer’s
The submission relates to patients with mild cognitive impairment or mild dementia due to Alzheimer’s. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date
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
Under the agreement, MediLink will receive upfront and near-term milestone payments totalling $570m. Additional development, regulatory, and commercial milestone payments are included in the deal, along with tiered