Moderna says FDA to review its flu vaccine
Digest more
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.
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.
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,