A comprehensive view of New Drug / Biologic License Application (NDA / BLA). This page highlights a small sample of our full coverage.
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Recent Articles

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Sanofi reports 34% reduction in COPD exacerbations in second Phase 3 trial of Dupixent, plans to submit BLA by end of 2023; nearly 300,000 people in US have uncontrolled COPD with type 2 inflammation

Alladapt Immunotherapeutics receives FDA fast track designation for its investigational ADP101 multi-food oral immunotherapy for the treatment of mono- and multi-food allergies

Bristol Myers Squibb and 2seventy bio provide update on FDA review of sBLA for Abecma idecabtagene vicleucel in earlier lines of therapy for triple-class exposed relapsed or refractory multiple myeloma

Janssen Pharmaceutical submitts a supplemental biologics license application to the FDA for approval of RYBREVANT injectable plus chemotherapy for treatment of non-small cell lung cancer after prior osimertinib therapy

Bayer to collaborate with FDA on voluntary withdrawal of Aliqopa for relapsed follicular lymphoma treatment in the US; Bayer is exploring access options for current Aliqopa patients

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