New Drug Application Submission Initiated for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program

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CAMBRIDGE, Mass., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today announced the initiation of a New Drug Application...

New Drug Application Submission Initiated for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program

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This is a paid press release. Contact the press release distributor directly with any inquiries. New Drug Application Submission Initiated for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program...

Early disease control with a biochemical response to aumolertinib after postoperative recurrence of EGFR-Mutant stage IIIA lung adenocarcinoma after icotinib, with EGFR T790M detected at recurrence: a Case Report

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BackgroundEpidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are a standard treatment for EGFR-mutant non-small cell lung cancer (NSCLC) Abstract Background: Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are a standard treatment for EGFR-mutant non-small cell lung cancer (NSCLC)....

First-Line Amivantamab-chemotherapy vs Chemotherapy in NSCLC With EGFR Exon 20 Insertions: Overall Survival From PAPILLON

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First-Line Amivantamab-chemotherapy vs Chemotherapy in NSCLC With EGFR Exon 20 Insertions: Overall Survival From PAPILLON The Phase 3 PAPILLON study evaluated first-line amivantamab plus chemotherapy versus chemotherapy alone in patients with advanced non-small cell lung cancer with EGFR Exon 20...

Berberine and celecoxib synergistically suppress non-small cell lung cancer with EGFR/AKT/COX-2-related signaling: network pharmacology, molecular docking and experimental validation

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BackgroundNon-small cell lung cancer (NSCLC) remains a major cause of cancer-related mortality, and safer combination strategies with improved antitumor effi Abstract Background: Non-small cell lung cancer (NSCLC) remains a major cause of cancer-related mortality, and safer combination strategies with improved...

HUTCHMED Announces Submission of US NDA for ORPATHYS® plus TAGRISSO® in MET-Driven EGFR-Mutated Lung Cancer

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HONG KONG, SHANGHAI and FLORHAM PARK, N.J., Sept. 28, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that AstraZeneca has submitted a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) for ORPATHYS®...

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