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This approval covers adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) who have carcinoma in situ (CIS), with or without papillary tumours. The authorisation follows a review

The FDA has approved Opdivo, along with doxorubicin, vinblastine, and dacarbazine (AVD) for adults and paediatric patients aged 12 years and above who have not previously been treated

Under the contract, Novartis will pay $2bn upfront and up to $1bn in milestones to acquire Synnovation Therapeutics’ wholly owned subsidiary Pikavation Therapeutics, which holds SNV4818 and related

The portfolio includes programmes targeting melanocortin 4 receptor (MC4R)-deficient genetic obesity, glucocerebrosidase 1 (GBA1)-driven Parkinson’s disease, and Alpha-1 antitrypsin deficiency. The financing was co-led by Dimension and OrbiMed,

The company also secured an exclusive global licence for the development and commercialisation of AP306 with Alebund Pharmaceuticals, excluding Greater China. The funding will support the global development

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