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news.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
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
Otsuka’s NDA covers the use of centanafadine as a treatment for ADHD in adolescents, adults, and children. Centanafadine is a norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). The
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
Agreed in December 2025, the transaction is valued at up to $820m and brings the late-stage monoclonal antibody brelovitug, a candidate for chronic hepatitis delta virus (HDV), into
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
For the entire year, sales grew by 6% to $94.2bn, and full-year earnings per share (EPS) registered at $11.03. The diluted earnings per share (EPS) for Q4 2025
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 will deploy radiology AI algorithms cleared by the US Food and Drug Administration (FDA) through Microsoft’s Precision Imaging Network, a component of its healthcare radiology solutions.
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