Last edition
News about "supplemental Biologics License Application "
US Food and Drug Administration grants Priority Review to supplemental application for Enhertu to treat HER2-positive breast cancer patients with residual disease after neoadjuvant therapy, with decision expected in Q3 2026.
Supplemental Biologics License Application | 10/03/2026 | By News Bureau
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 | 134
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 | 133
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 | 523
We use our own and third party cookies to produce statistical information and show you personalized advertising by analyzing your browsing, according to our COOKIES POLICY. If you continue visiting our Site, you accept its use.
More information: Privacy Policy