Boehringer Ingelheim GmbH’s zongertinib enters the market as the first oral HER2-targeted therapy for patients with non-small-cell lung cancer, following an accelerated approval by the U.S. FDA. Branded Hernexeos, the drug is cleared for use in adults with unresectable disease or whose tumors have HER2 tyrosine kinase domain activating mutations and who have received prior systemic therapy.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cybin, Fibrogen, Jazz, OS Therapies, Valneva.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Absci, Almirall, Coherus, Cormedix, Intas, Keros, Melinta, Novo Nordisk, Prothena.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Assembly, Braintree, Eledon, Eli Lilly, OS, Palisade, Sellas, Spinogenix.
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