Novartis Tabrecta Is First Treatment For NSCLC With METex14 Mutation
The US FDA granted an accelerated approval for the lung cancer treatment targeting a mutation found in only about 4,000-5,000 NSCLC patients in the US each year.
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Amryt Pharmaceuticals is set to appear before the European Medicines Agency to explain why its treatment for patients with epidermolysis bullosa merits EU-wide approval. The drug was recently rejected in the US.
Foundation Medicine and Novartis’ commercial partnership has achieved another success as Foudation’s Liquid CDx is approved.
Japan’s regulators have approved a large batch of new products, including a novel antibody from Chugai, two world-first nods for the country’s second HIF-PH inhibitors and an asthma therapy, and the first Humira biosimilar in Japan – as well as five drugs from Novartis.