China-based Dizal Pharmaceutical Co., Ltd (SHEX: 688192) has announced that its New Drug Application (NDA) for sunvozertinib has been accepted for review by the US FDA with priority review status. The EGFR inhibitor is targeting approval to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
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Dizal’s Sunvozertinib Receives Priority Review from FDA for EGFR Exon 20 NSCLC

Boehringer Ingelheim and Sutro Achieve Commercial-Scale Manufacturing of Luvelta
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Boehringer Ingelheim and Sutro Achieve Commercial-Scale Manufacturing of Luvelta

Variant Bio Partners with Novo Nordisk to Discover Novel Targets for Metabolic Diseases
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Variant Bio Partners with Novo Nordisk to Discover Novel Targets for Metabolic Diseases

AbbVie Exercises Option for Capsida's Neurodegenerative Disease Program
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AbbVie Exercises Option for Capsida’s Neurodegenerative Disease Program

Eyebright Medical's Loong Crystal PR Receives NMPA Class III Medical Device Approval
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Eyebright Medical’s Loong Crystal PR Receives NMPA Class III Medical Device Approval

CSPC Pharmaceutical Group Receives NMPA Approvals for ADC SYS6045 and PDE4B Inhibitor SYH2059
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CSPC Pharmaceutical Group Receives NMPA Approvals for ADC SYS6045 and PDE4B Inhibitor SYH2059

Kelun-Biotech's Anti-HER2 ADC A166 Receives NMPA Review for Expanded Indication
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Kelun-Biotech’s Anti-HER2 ADC A166 Receives NMPA Review for Expanded Indication

PostEra Expands Partnership with Pfizer to Launch New ADC Collaboration
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PostEra Expands Partnership with Pfizer to Launch New ADC Collaboration

Merck KGaA Adopts Quris AI's Bio-AI Platform for Drug Development Pipeline
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Merck KGaA Adopts Quris AI’s Bio-AI Platform for Drug Development Pipeline

Hansoh and GSK's HS-20093 Receives FDA Breakthrough Therapy Designation for Osteosarcoma
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Hansoh and GSK’s HS-20093 Receives FDA Breakthrough Therapy Designation for Osteosarcoma

Boehringer Ingelheim China and Shanghai Pharmaceuticals Holding Co. Launch Strategic Partnership for Linagliptin
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Boehringer Ingelheim China and Shanghai Pharmaceuticals Holding Co. Launch Strategic Partnership for Linagliptin

Merck KGaA Completes Acquisition of HUB Organoids, Expanding Cell Culture Portfolio
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Merck KGaA Completes Acquisition of HUB Organoids, Expanding Cell Culture Portfolio