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The two firms expect the agency to recommend marketing authorization approval for the monoclonal antibody AVT04, as soon as in the second half of this year. Stelara is

Adtralza has received approval to treat AD in people aged 12 to 17 years whose disease is not adequately controlled with topical prescription therapies or when those therapies

Danon Disease is a fatal genetic cardiac disease for which there are no disease-altering treatments currently available. RMAT designation was granted by the regulatory body based on positive

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