News about "Biologics License Application "

AstraZeneca's Imfinzi Granted Priority Review by FDA for Early-Stage Gastric and GEJ Cancers

AstraZeneca's Imfinzi Granted Priority Review by FDA for Early-Stage Gastric and GEJ Cancers

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) and granted Priority Review for the treatment of patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.

Biologics License Application | 28/07/2025 | By Dineshwori

AbbVie Submits BLA to FDA for Teliso-V in Previously Treated Non-Small Cell Lung Cancer

AbbVie Submits BLA to FDA for Teliso-V in Previously Treated Non-Small Cell Lung Cancer

AbbVie has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for accelerated approval of telisotuzumab vedotin (Teliso-V).

Biologics License Application | 30/09/2024 | By Aishwarya 289

Telix Completes TLX250-CDx BLA Submission for Kidney Cancer Imaging

Telix Completes TLX250-CDx BLA Submission for Kidney Cancer Imaging

Telix Pharmaceuticals has completed the submission of a Biologics License Application (BLA) to the United States (US) Food and Drug Administration (FDA) for its investigational radiodiagnostic PET agent.

Biologics License Application | 03/06/2024 | By Aishwarya 212

US FDA Grants Priority Review to Sarclisa for Treatment of Transplant-Ineligible NDMM

US FDA Grants Priority Review to Sarclisa for Treatment of Transplant-Ineligible NDMM

Sanofi has announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of Sarclisa (isatuximab).

Biologics License Application | 28/05/2024 | By Aishwarya 495


 

 

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