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Armed with positive results from two late-stage studies, Germany’s Novaliq has submitted a New Drug Application (NDA) to the FDA for its novel treatment for dry eye disease. Read More
FDA has approved Enhertu (fam-trastuzumab-deruxtecan-nxki), the first approved therapy targeted to patients with unresectable or metastatic HER2-low breast cancer subtype, a newly defined subset of HER2-negative breast cancer. Read More
The approval was supported by results of a phase 3 clinical trial in which Lynparza demonstrated statistically significant improvements in invasive disease-free survival. Read More