News about "Biologics License Application "

Partner Therapeutics Submits sBLA to FDA for BIZENGRI

Partner Therapeutics submits sBLA to FDA for BIZENGRI in NRG1 fusion-positive cholangiocarcinoma, supported by eNRGy study data showing 36.8 percent response rate and durable efficacy.

Biologics License Application | 15/04/2026 | By News Bureau

Ifinatamab Deruxtecan Gets US Priority Review for Small Cell Lung Cancer

Ifinatamab deruxtecan receives US Priority Review for Small Cell Lung Cancer, supported by Phase 2 data, with potential as a first-in-class B7-H3 targeted Antibody Drug Conjugate.

Biologics License Application | 13/04/2026 | By News Bureau

DualityBio Secures China NMPA BLA Acceptance for Trastuzumab Pamirtecan in HER2+ Breast Cancer

DualityBio announces China NMPA acceptance of its BLA for trastuzumab pamirtecan, targeting unresectable or metastatic HER2-positive breast cancer in adult patients.

Biologics License Application | 10/04/2026 | By News Bureau

Vanda Pharmaceuticals's Imsidolimab BLA Accepted by U.S. Food and Drug Administration for Rare Skin Disease GPP

Vanda’s imsidolimab moves closer to approval as the FDA accepts its BLA for generalised pustular psoriasis, a rare and life-threatening inflammatory skin disorder.

Biologics License Application | 02/03/2026 | By News Bureau |  117

Hansa Biopharma's Imlifidase BLA Accepted by US FDA for Priority Review

FDA accepts Hansa Biopharma’s BLA for imlifidase, supported by strong Phase III ConfIdeS data demonstrating significant kidney function improvement in highly sensitized transplant patients.

Biologics License Application | 20/02/2026 | By News Bureau |  254

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 |  219

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 |  165

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 |  159

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 |  498

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 |  385