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News about "Biologics License Application "
ImmunityBio Advances FDA Talks on ANKTIVA Resubmission
ImmunityBio said the FDA has requested additional information to potentially support a resubmission of the sBLA for ANKTIVA in BCG-unresponsive papillary bladder cancer, without requiring new clinical trials, with the company planning to submit the data within 30 days.
Biologics License Application | 21/01/2026 | By News Bureau | 105
FDA Accepts for Review INOVIO BLA for INO-3107 in RRP
The US FDA has accepted for review INOVIO’s Biologics Licence Application (BLA) for INO-3107 for the treatment of adults with Recurrent Respiratory Apillomatosis (RRA), assigning a PDUFA action date of 30 October, 2026, and indicating that it does not currently plan to convene an advisory committee meeting for the application.
Biologics License Application | 31/12/2025 | By News Bureau | 108
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 | 136
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 | 428
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 | 369
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 | 670
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