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News about "Biologics Licence Application "
AbbVie Provides US Regulatory Update on TrenibotE BLA
AbbVie gets US FDA Complete Response Letter (CRL) for TrenibotE BLA tied to manufacturing processes; no new clinical studies needed.
Biologics Licence Application | 24/04/2026 | By News Bureau
US FDA Approves Sanofi's Tzield to Delay Type 1 Diabetes Progression in Children
Sanofi’s Tzield gains US FDA approval to delay stage-III Type 1 Diabetes in children aged one year and above, the first disease-modifying therapy for stage-II T1D.
Biologics Licence Application | 24/04/2026 | By News Bureau
China Grants Priority Review to Leqembi Subcutaneous BLA
The Priority Review and Approval Procedure has been implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this procedure, the assessment period is expected to be shortened.
Biologics Licence Application | 11/02/2026 | By News Bureau | 128
Immix Biopharma Gets US FDA Breakthrough Therapy Designation for NXC-201
Immix Biopharma has received US FDA Breakthrough Therapy Designation for its CAR-T candidate NXC-201, based on positive interim phase-II results from the NEXICART-2 study presented at the ASH 2025 annual meeting, with final data expected later this year followed by a planned Biologics Licence Application (BLA) submission.
Biologics Licence Application | 29/01/2026 | By News Bureau | 143
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