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 US Food and Drug Administration (FDA) has accepted for priority review Otsuka Pharmaceutical’s new drug application (NDA) submitted for centanafadine, an investigational, once-daily extended-release capsule for attention-deficit hyperactivity disorder (ADHD) treatment.
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
The new solution is intended for pharmaceutical and medical device manufacturers, enabling them to train operators, guide execution, and verify critical tasks using advanced AI-technologies. Pharmaceutical manufacturers frequently
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