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FDA accepts Sobi’s Gamifant application for HLH/MAS treatment
The application, which seeks approval for use in both adult and paediatric individuals who show an insufficient response or are not tolerant to glucocorticoids, or with recurrent MAS, has received ...
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FDA ‘breakthrough’ status – a new tool for building oncology brands?
The FDA's new Breakthrough Therapy designation ... One company is already using breakthrough therapy status application itself as positive PR: Novartis boldly announced on May 6th of this year ...
Regeneron: FDA Accepts Odronextamab Lymphoma Drug Resubmission
Regeneron last year won European Commission approval of odronextamab as Ordspono for relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma after two or more lines of systemic ...