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News about "Biologics License Application "
Alvotech Gets FDA Approval for Second AVT02 Manufacturing Suite
Alvotech receives FDA approval to manufacture AVT02 drug substance in its second Reykjavik production suite.
Biologics License Application | 06/10/2026 | By News Bureau
Mirum's Brelovitug Meets Phase 3 Endpoint in Chronic Hepatitis Delta
Mirum Pharmaceuticals reports positive Phase 3 AZURE-1 results for brelovitug, with the investigational antibody meeting its primary endpoint in chronic HDV.
Biologics License Application | 29/09/2026 | By News Bureau
AstraZeneca Reports Positive Phase 3 Results for Tozorakimab in COPD
AstraZeneca’s Phase 3 OBERON and TITANIA trials showed that tozorakimab reduced moderate-to-severe COPD exacerbations across broad patient populations, including different blood eosinophil levels and smoking statuses.
Biologics License Application | 10/09/2026 | By News Bureau | 106
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 | 116
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 | 102
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 | 133
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 | 134
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 | 154
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 | 254
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 | 135
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