Novo Nordisk receives FDA approval for basal insulin Awiqli
It is indicated as an adjunct to exercise and diet for improving glycaemic control. The FDA’s decision is based on data from the ONWARDS Phase IIIa clinical programme,
Teva Pharmaceutical has announced the US Food and Drug Administration (FDA) approval for Ponlimsi (denosumab-adet) as a biosimilar to Prolia, alongside the acceptance of its biosimilar candidate applications for Xolair (omalizumab) by both the agency and the European Medicines Agency (EMA).
The partnerships aim to apply AI within scientifically validated modelling workflows and define scalable, next-generation approaches throughout the drug development life cycle. The programmes will use Simulations Plus
The initiative will combine Cognito Therapeutics’ investigational Spectris technology platform with the clinical infrastructure of Ochsner Health to explore innovative approaches to brain health across urban and rural
The agreement grants Sanofi worldwide rights to KT501, which is under evaluation in a first-in-human clinical trial for rheumatoid arthritis, focusing on tolerability, safety, pharmacodynamics, and pharmacokinetics. Under