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News about "Biologics License Application "
GSK's Jemperli Receives FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer
GSK’s Jemperli has received FDA priority review for previously untreated dMMR/MSI-H locally advanced rectal cancer, following positive phase 2 AZUR-1 results.
Biologics License Application | 26/08/2026 | By News Bureau
US FDA Approves Teleflex's Ezplaz Freeze Dried Plasma, First Licensed FDP in the US
Teleflex has received US FDA Biologics License Application (BLA) approval for Ezplaz Freeze Dried Plasma, the first FDA-licensed freeze-dried plasma product in the United States.
Biologics License Application | 31/07/2026 | By News Bureau
Dyne Therapeutics' Duchenne Muscular Dystrophy Therapy Receives FDA Priority Review
FDA accepts Biologics License Application for investigational exon 51-skipping therapy z-rostudirsen, with a regulatory decision expected by January 2027.
Biologics License Application | 22/07/2026 | By News Bureau
China Grants Priority Review to Leads Biolabs' Opamtistomig for Advanced Neuroendocrine Carcinoma
NMPA accepts biologics license application under expedited review pathway for investigational PD-L1/4-1BB bispecific antibody targeting advanced extrapulmonary neuroendocrine carcinoma after multiple prior therapies.
Biologics License Application | 13/07/2026 | By News Bureau | 109
FRONTIER4 extension study demonstrates sustained safety, low bleeding rates and flexible dosing across children, adolescents and adults, while new data on concizumab highlights reduced bleeding episodes in pediatric patients with hemophilia.
Biologics License Application | 13/07/2026 | By News Bureau | 126
Galderma has received a Complete Response Letter from the US FDA for its RelabotulinumtoxinA Biologics License Application, with observations limited to manufacturing processes and analytical methods.
Biologics License Application | 02/07/2026 | By News Bureau | 182
Roche's Enspryng Receives FDA Priority Review for Thyroid Eye Disease
Roche's Enspryng has received FDA Priority Review for thyroid eye disease after Phase 3 studies demonstrated clinically meaningful improvements in eye bulging, disease activity and double vision, with a regulatory decision expected by October 2026.
Biologics License Application | 01/07/2026 | By News Bureau | 107
Sobi Receives FDA Complete Response Letter for Experimental Gout Therapy NASP
Sobi has received a Complete Response Letter from the US FDA for its investigational gout therapy NASP, with the regulator requesting additional manufacturing data and facility-related information before considering approval. The company plans to work with the FDA and its manufacturing partners toward resubmitting the application.
Biologics License Application | 29/06/2026 | By News Bureau
Zai Lab Secures China Approval for TIVDAK
Zai Lab has received China NMPA approval for TIVDAK (tisotumab vedotin), the first Antibody-Drug Conjugate (ADC) approved for previously treated recurrent or metastatic cervical cancer in China. The approval is supported by phase 3 innovaTV 301 trial data demonstrating a statistically significant overall survival benefit.
Biologics License Application | 09/06/2026 | By News Bureau | 189
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 | 155
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