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This CRL stated that the application lacks substantial evidence of efficacy from adequate and well-controlled clinical investigations under the proposed conditions of use. The FDA noted inconsistencies in

The move enables Sentynl to collaborate immediately with PRG S&T to advance clinical development of the molecule, which holds orphan drug status from the US Food and Drug

This marks Cosentyx as the first interleukin-17A (IL-17A) inhibitor approved for this population, offering a new biologic treatment option for paediatric patients with HS. HS is a chronic,

The partnership aims to investigate ways to implement quantum computing solutions throughout the healthcare value chain, with a focus on resource allocation, research and development, and patient outcomes

The approval marks the first authorised treatment for cerebral folate deficiency, a rare genetic neurological disorder affecting brain folate transport. It followed a systematic review of published literature,

The collaboration will integrate NewcelX’s NCEL-101 with Eledon’s investigational anti-cluster of differentiation 40 ligand (anti-CD40L) monoclonal antibody, tegoprubart (AT-1501), to support durable, immune-protected islet replacement and develop a

This marks the first FDA approval of a TYK2 inhibitor specifically for this indication. The regulator granted this approval following findings from the pivotal POETYK PsA-I and POETYK

The licences sourced from Carisma Therapeutics and the University of Pennsylvania include methods and constructs specifically engineered for function within these immune cell populations. The designs complement Liberate Bio’s

AFTX-201 is being evaluated as a one-time intravenous gene therapy in adults with genetically confirmed BAG3 DCM. The therapy delivers a fully human, full-length BAG3 transgene using the