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Moderna says FDA to review its flu vaccine

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CIDRAP · 6h
Double-reverse: FDA now says it will review Moderna’s mRNA flu vaccine
One week after saying it was refusing to review Moderna’s application for approval of a new flu vaccine, the US Food and Drug Administration's (FDA’s) Center for Biologics Evaluation and Research (CBE...

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 · 1h · on MSN
FDA Reverses Course, Will Review Moderna's mRNA Flu Vaccine
 · 10h
FDA to review Moderna's mRNA flu vaccine after initial rejection
 · 13h
FDA reverses course, will review Moderna's mRNA flu vaccine
Moderna said on Wednesday the U.S. Food and Drug Administration has agreed to review its influenza vaccine, reversing an earlier decision to reject the application, after the company made modification...

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 · 12h
FDA Reverses Course and Will Now Review Moderna’s Flu Shot
 · 13h
F.D.A. Reverses Decision and Agrees to Review Moderna’s Flu Vaccine
1don MSN

Disc Medicine eyes standard US approval for drug after FDA denies fast-track nod

By Siddhi Mahatole Feb 17 (Reuters) - Disc Medicine said on Tuesday it will pursue a traditional U.S. approval pathway for its rare disease drug after the Food and Drug Administration declined to approve the treatment under a new fast-track review program.
The American Journal of Managed Care
2d

FDA Approval of Sibeprenlimab Signals New Era in IgA Nephropathy: Jackson Peter Kim, MD

In an interview, Jackson Peter Kim, MD, clinical assistant professor in the Division of Nephrology at Stanford Health Care, described his initial reaction as one of optimism. In a field that “was so limited before,” he said, the arrival of a new agent—and recognition from the FDA through the accelerated pathway—was encouraging.
Healio
5d

Safety updates ‘common’ for cancer drugs granted FDA accelerated approval

Nearly 70% of cancer drugs granted FDA accelerated approval between 2011 and 2020 required safety updates within 4 years.“Postmarketing safety actions are common,” Maryam Mooghali, MD, MSc, internal medicine resident physician at Yale New Haven Hospital,
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