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US FDA approves Eisai-Biogen’s antibody for Alzheimer’s

Pharmaceutical Technology

Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD).

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Rystiggo receives FDA approval, strengthening UCB’s myasthenia gravis portfolio

Pharmaceutical Technology

UCB's Rystiggo has been granted FDA approval to treat myasthenia gravis in anti-AchR or anti-MuSK antibody-positive adults.

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AstraZeneca, Daiichi Sankyo Win First Tumor-Agnostic HER2 FDA Approval for Enhertu

BioSpace

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu is the first FDA-approved tumor-agnostic HER2-targeted therapy authorized for the treatment of solid tumors in adults who have undergone prior systemic treatment.

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Daiichi Sankyo and AstraZeneca’s lung cancer antibody set for FDA review

Pharmaceutical Technology

An FDA approval in late 2024 would make it the first TROP2-directed therapy for NSCLC antibody drug conjugate patients.

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FDA approves IND application for Nanjing Leads Biolabs’ bispecific antibody

Pharmaceutical Technology

US FDA and China’s NMPA have approved the Phase I trial of anti-GPRC5D/CD3 bispecific antibody (LBL-034) by Leads Biolabs.

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FDA approves Amgen drug for tough-to-treat form of lung cancer

Bio Pharma Dive

Imdelltra, a bispecific antibody targeting a protein called DLL3, is cleared for use following chemotherapy in treating extensive-stage small cell lung cancer.

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FDA approves Regeneron antibody drug as first Ebola virus treatment

Bio Pharma Dive

Research for the drug, now cleared as Inmazeb, helped Regeneron jumpstart its fast development of an antibody therapy for COVID-19.

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