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news.MHRA launches call for evidence on AI regulation in UK healthcare sector
The initiative aims to shape future standards and safeguards for the way AI is used in healthcare settings. This call for evidence will inform the work of the
The initiative aims to shape future standards and safeguards for the way AI is used in healthcare settings. This call for evidence will inform the work of the
The approval covers all existing indications for Rybrevant. The SC formulation reduces administration time from several hours to five minutes, compared to intravenous (IV) delivery, offering increased patient
Formycon will complete the development of FYB206, prepare and file the regulatory dossier, and supply the biosimilar product. Zydus will manage its commercialisation. FYB206 is nearing the end
The once-daily oral therapy is administered as a 14-day course. Clinical trials demonstrated benefits from as early as day three, with significant symptom reduction by day 15, and
Lupus nephritis classifications indicate the severity and type of kidney damage, which is central to the disease. The EC’s decision is based on outcomes from the Phase II
The Digital Acceleration of Toxicity Assessment with Mechanistic and AI-driven Predictions (DATAMAP) project, in collaboration with Baylor College of Medicine, Amgen, Torch Bio and Cincinnati Children’s Hospital Medical
Viatris will sell all of its convertible preferred equity in Biocon Biologics. The deal value comprises $415m in newly issued Biocon equity shares and $400m in cash. The
The initiative aims to enhance biotechnology research and innovation in the region. The new memorandum of understanding (MOU) was signed to mark the 15-year collaboration between the two
Denali’s lead investigational TransportVehicle-enabled enzyme replacement therapy is intended to treat mucopolysaccharidosis type II (Hunter syndrome, a rare genetic disorder affecting boys). The US Food and Drug Administration
In October 2025, the two companies signed the deal as part of their focus on bispecifics and ADCs. The agreement aims to expedite the worldwide development and commercialisation