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Basilea announces submission of a New Drug Application to the US Food and Drug Administration for its antibiotic ceftobiprole

Basilea Pharmaceutica Ltd, Allschwil, a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced that it has submitted a New Drug Application to the US Food and Drug Administration.

Basilea announces submission of a New Drug Application to the US Food and Drug Administration for its antibiotic ceftobiprole Read More »

Mesoblast Receives Complete Response From U.S. Food and Drug Administration for Biologics License Application for Steroid-Refractory Acute Graft Versus Host Disease in Children

Mesoblast Limited announced that the US Food and Drug Administration has provided a complete response to its Biologics License Application resubmission for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease and requires more data to support marketing approval.

Mesoblast Receives Complete Response From U.S. Food and Drug Administration for Biologics License Application for Steroid-Refractory Acute Graft Versus Host Disease in Children Read More »

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