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After granting priority review for the application, the FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of 5 August 2023. The drug is being evaluated

TAKHZYRO is a completely human monoclonal antibody that particularly binds and reduces plasma kallikrein activity.   Before this approval, the only approved routine prophylaxis treatment options for children

These therapies activate the immune response selectively within the microenvironment of the tumours. Purple Biotech is acquiring all the shares of Immunorizon in exchange for $3.5m upfront payment

Initially, the FDA approved Benlysta for the treatment of active systemic lupus erythematosus (SLE). GSK noted that it is the first and only approved biologic for SLE as

AB-101 is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use along with monoclonal antibodies or innate-cell engagers in the out-patient environment. Artiva

The optogenetic monotherapy has been developed to restore vision in blind patients. Nanoscope CEO Sulagna Bhattacharya said: “We are pleased to receive the FDA’s decision to grant Fast

The European Commission (EC) will now review the recommendation. On receiving approval, this would represent the third authorised indication for the therapy in the EU. Approved in the

Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody intended to treat AD with confirmed amyloid pathology. On 6 January, it received accelerated approval from the US Food

The funding round has seen participation of current investors Boehringer Ingelheim Venture Fund, M. Ventures, PMV, Gemma Frisius Fonds, and CD3/ KU Leuven. As part of the investment,