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The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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The Swiss pharma’s fourth-quarter sales fell short of analysts’ estimates on Wednesday, as the company said it dropped a late-stage blood cancer hopeful after failing a Phase III study.
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Defender Pharmaceuticals on Tuesday did not reveal the reasons for the regulator’s rejection of its nasal gel version of scopolamine. The company is seeking a meeting with the FDA to “understand the issues.”