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The FDA has requested further information, primarily focusing on the manufacturing control strategy of the biological component of NASP and on deficiencies related to contract manufacturing facilities. It

This Jaypirca CHMP recommendation for CLL applies across all lines of therapy, regardless of previous Bruton tyrosine kinase (BTK) inhibitor treatment. Following this recommendation, the Jaypirca application moves

The initial phase of the partnership, valued at up to $15m and running until 2027, may be expanded if scientific milestones are met and both parties agree. The

Ionis will retain the responsibility for commercialising the RNA-targeted medicine within the US and will remain the global lead for development activities. Under the agreement, Recordati will handle regulatory

The authorisation applies to adults with resectable MIBC who cannot be treated with cisplatin-based chemotherapy. It makes the combination the first regimen that pairs a programmed death-1 (PD-1)

Frazier Life Sciences led the financing round along with new investors EQT Life Sciences, Forbion, Monograph and Wellington Management. LifeArc Ventures, Oxford Science Enterprises and the University of

The partnership will combine Combotope’s SMART-Phage discovery platform with Boehringer Ingelheim’s research and development capabilities, focusing on multiple identified oncology targets. Combotope CEO Ola Blixt said: “At Combotope,

Nuvectis secured worldwide rights, outside specified Asian territories, to develop, manufacture and commercialise Haisco’s drug candidates HSK42360 and HSK39297. Haisco will receive $40m in upfront and near-term payments,

This expands intellectual property protection already in place for Genprex in jurisdictions such as China, Europe, Japan, Russia and the US. Genprex’s Reqorsa is currently in development alongside