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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 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

This marks the first instance of an allogeneic induced pluripotent stem cell (iPSC)-derived cell therapy receiving both fast track and RMAT designations from the FDA, with the former

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

Menkes disease is a rare X-linked recessive disorder caused by mutations in the ATP7A gene, resulting in impaired copper absorption and transport. Zycubo is administered subcutaneously to restore