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News about "supplemental Biologics License Application "
Johnson & Johnson Submits sBLA to US FDA for IMAAVY in Warm Autoimmune Hemolytic Anemia
Johnson & Johnson has filed a supplemental biologics application seeking US approval of IMAAVY (nipocalimab) for warm autoimmune hemolytic anemia, a rare disorder with no currently approved treatments.
Supplemental Biologics License Application | 26/02/2026 | By News Bureau
The FDA has granted Priority Review to Datroway for first-line treatment of metastatic triple-negative breast cancer patients ineligible for immunotherapy, with a regulatory decision expected in Q2 2026.
Supplemental Biologics License Application | 04/02/2026 | By News Bureau | 100
Johnson & Johnson Submits Application to US FDA Seeking Approval of TREMFYA
Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking approval of TREMFYA (guselkumab) for the treatment of adults with moderately to severely active Crohn's disease.
Supplemental Biologics License Application | 21/06/2024 | By Aishwarya | 500
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