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The approval was based on positive results from a phase 2 trial that showed Enhertu led to improvement in overall survival and response rate vs. chemotherapy. Read More
Roche said the approval “marks the first innovation in mechanism of action for an influenza antiviral” approved by the European Commission in almost 20 years. Read More
The drug was first approved in 2014 for treating type 2 diabetes and for reducing the risk of cardiovascular death in patients with type 2 diabetes. Read More
The UK has approved Moderna’s COVID-19 vaccine through a temporary authorization pathway, gaining a third option to add to approved vaccines from AstraZeneca/Oxford University and Pfizer/BioNTech. Read More
The late-stage trial found that the safety and tolerability of the drug was consistent with its well-established safety profile, AstraZeneca said. Read More