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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
The FDA has approved Coherus BioSciences’ Cimerli (ranibizumab-eqrn) as the first interchangeable biosimilar for Roche’s retinal disease blockbuster Lucentis across all five of its indications. Read More
The approval provides another treatment option for pediatric patients, who were previously given non-selective immunosuppressants and corticosteroids, the company said. Read More
Sandoz’s biosimilar of Biogen’s blockbuster multiple sclerosis drug Tysabri (natalizumab) has gained new regulatory footholds with both the FDA and the European Medicines Agency (EMA). Read More