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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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In this Employment Outlook report, BioSpace explores current workforce sentiment, job activity trends and the prospective job and hiring outlook for 2025, particularly as it compares to the previous year.
Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners’ Datroway for a related type of breast cancer.
Starboard last year took a $1 billion stake in Pfizer, looking to turn the pharma around after alleged severe shortcomings by its current leadership. But Bloomberg reports it has missed the deadline for nominating a director to the pharma’s board.
Little information has emerged about osavampator, a potentially first-in-class drug, since its promising Phase II performance last spring.
After two years characterized by layoffs, pipeline reorganizations, FDA delays and clinical holds, Novavax CEO John Jacobs says the company is at a pivot point.