News about "Biologics License Application "

LEQEMBI IQLIK Subcutaneous Dose Gets US FDA Priority Review for Early Alzheimer's Disease

LEQEMBI IQLIK subcutaneous dose review by US Food and Drug Administration (FDA) extended after major sBLA amendment for early Alzheimer’s disease, with no approvability concerns raised.

Biologics License Application | 11/05/2026 | By News Bureau

US Food and Drug Administration Extends Review Timeline for Sarclisa Subcutaneous Formulation

FDA extends review timeline for Sanofi’s Sarclisa subcutaneous formulation, a potential first-in-class on-body injector therapy for multiple myeloma patients.

Biologics License Application | 23/04/2026 | By News Bureau |  131

Roche Secures FDA Review for Lupus Drug Gazyva

Roche’s Gazyva moves closer to approval for systemic lupus erythematosus after FDA accepts application backed by Phase III trial results showing improved disease control and remission rates.

Biologics License Application | 22/04/2026 | By News Bureau

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 |  119

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 |  135

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 |  171

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 |  303

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 |  259

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 |  187