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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 regulatory action date for the humanised immunoglobulin G1, kappa (IgG1/k) monoclonal antibody sBLA review is anticipated by 29 October 2026. If approved, this would expand the therapy’s

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

Supported by Enterprise Singapore, the initiative aims to enhance Biophytis’ computational longevity platform and develop therapies for age-related diseases such as sarcopenia. The collaboration builds on Biophytis’ ongoing

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 targets membrane proteins, intracellular protein–protein interactions and complex receptor systems through a new drug discovery platform. It aims to target disease areas where conventional small-molecule drug

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 contract covers a full technology transfer for the vaccine manufacturing process from Bavarian Nordic to SII, aiming to increase production capacity and future supply for endemic low-

Neupharma will gain exclusive rights for the development and commercialisation of the therapy, addressing a condition currently lacking approved targeted treatments. The company will fund and conduct a