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Notizia - Recent Pharma, Healthcare and Biotech Happenings

US Greenlight for Datroway Marks First TROP2 ADC Approval in Frontline mTNBC Beyond PD-1/PD-L1 Candidates; Gilead’s Hepcludex Achieves Historic FDA Approval Milestone in Chronic HDV; Biogen and Denali Therapeutics Report Progress in Phase 2b Evaluation of BIIB122 for Parkinson’s Disease; Eli Lilly and Company Spotlights Foundayo’s Late-Stage Success in Obesity Studies; BioMarin Shares Successful Phase 3 Study Outcomes for VOXZOGO® in Children with Hypochondroplasia

US Approves Datroway as the First TROP2-directed ADC for 1L mTNBC Patients Unsuitable for PD-1/PD-L1 Therapy AstraZeneca and Daiichi Sankyo have secured US approval for Datroway for treating adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are ineligible for PD-1/PD-L1 inhibitor therapy. The approval was granted following Priority Review by the FDA and was supported by findings from the Phase III TROPION-Breast02 study, presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. In the study, Datroway achieved a statistically significant and clinically meaningful 5.0-month improvement i...

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Aminex Therapeutics Secures FDA Orphan Drug Designation for AMXT 1501 + DFMO in Neuroblastoma; Eccogene Gets FDA Nod to Begin Phase IIa MOSAIC Trial of ECC4703 + ECC0509 in MASH; Orca Bio’s Orca-T Earns FDA Priority Review for Hematologic Malignancies; Alto Neuroscience Gains FDA Fast Track for ALTO-101 in Cognitive Impairment Linked to Schizophrenia; Taysha Gene Therapies Wins FDA Breakthrough Therapy Status for TSHA-102 in Rett Syndrome

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