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This designation could lead to seven years of marketing exclusivity on receipt of an approval, as well as exemption from user fees and eligibility for tax credits. Furthermore,

Tyruko is indicated as a single disease-modifying therapy (DMT) for adults diagnosed with highly active RRMS.  This is the same indication that was approved by the European Commission

Pancreatic cancer is known for its poor prognosis and high mortality rate. With a combined annual death toll of 139,000 in the US and European Union, it is

The approval allows Oricell to commence clinical development of OriCAR-017 in the US, with immediate effect. Utilising Oricell’s platforms, including OriAb antibodies, OriCAR construct, and unique CMC know-how,

The treatment is intended for usage in adults with priorly untreated la/mUC. This development marks a significant step towards potentially offering an alternative to the current standard platinum-containing

The facility is designed to bolster in-house production of drug substances for Investigational New Drug (IND)-enabling studies and trials. This development is pivotal for the company’s proprietary and

UGN-102 for intravesical solution is a new drug formulation of mitomycin. The drug utilises UroGen’s proprietary RTGel technology, which allows for sustained release and prolonged exposure to bladder

The OpCT-001 iPSC cell therapy candidate is intended for treating primary photoreceptor diseases. The latest move marks the first iPSC therapy candidate to be licensed from the strategic

This collaboration aims to improve the evaluation process for CAR T therapy for cancer patients. It focuses on five crucial factors to ensure timely and personalised care for