FDA's approval of AstraZeneca PLC's Imfinzi (durvalumab) is the latest example of the agency's growing preference for complementary diagnostics over the companion diagnostic paradigm that dominated the early days of targeted therapy and immunotherapy for cancer.
US FDA Continues Shift From Companion To Complementary PD-L1 Diagnostics With AstraZeneca Imfinzi Approval
AstraZeneca's Imfinzi (durvalumab) is the third PD-1/L1 inhibitor approved for second-line bladder cancer with labeling that describes better response rates in patients with higher PD-L1 expression, but without a requirement for diagnostic testing.
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Novo Nordisk’s application seeking EU marketing approval to use its GLP-1 receptor agonist to treat cirrhotic metabolic dysfunction-associated steatohepatitis is one of 15 new drug filings the European Medicines Agency has started reviewing. Meanwhile, Arrowhead’s filing for its familial chylomicronemia syndrome, plozasiran, is being fast tracked.
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The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.
Novo Nordisk’s application seeking EU marketing approval to use its GLP-1 receptor agonist to treat cirrhotic metabolic dysfunction-associated steatohepatitis is one of 15 new drug filings the European Medicines Agency has started reviewing. Meanwhile, Arrowhead’s filing for its familial chylomicronemia syndrome, plozasiran, is being fast tracked.
Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.