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The FDA has delayed Clovis Oncology’s bid to approve its new lung cancer treatment, asking for additional trial data that could see the March 30 PDUFA date extended. Read More
Japanese regulators are hoping to halve drug review times and speed up patient access to novel therapies by encouraging companies to file NDAs first in Japan, or in tandem with U.S. and EU submissions, under an approval pathway approved in April. Read More
The FDA has approved AstraZeneca’s metastatic non-small cell lung cancer drug Tagrisso in a first-of-its-kind indication targeting patients with the EGFR T790M mutation. Read More
It was a big day for Baxalta’s hemophilia franchise on Friday, with the company announcing that it had nabbed marketing authorization in the EU for Obizur, and the FDA giving its approval for Adynovate. Read More