US FDA extends review of KalVista's swelling disorder drug due to heavy workload
The FDA indicated that it now expects to deliver a decision within four weeks, KalVista said.
The original target action date for the decision on the medication, named sebetralstat, was set for June 17 by the regulator.
The extension is the latest instance of the FDA missing a deadline following mass layoffs under a major overhaul of federal health agencies under U.S. Secretary of Health and Human Services Robert F. Kennedy Jr.
The regulator also missed the target date for GSK's Nucala to treat smoker's lung.
KalVista said the FDA has not requested additional data or studies and has not raised any concerns regarding the safety, efficacy or approvability of sebetralstat.
The company also said it has addressed all prior information requests in a timely manner and believes the only remaining item under FDA review is the finalization of the packaging insert.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Independent
14 minutes ago
- The Independent
Teacher praises restrictions placed on phone use in classrooms
An Alabama teacher has praised a new state law banning mobile phones in school classrooms, noting significant improvements in student engagement and academic focus. Jonathan Buchwalter, a history teacher, observed that students were taking notes, completing assignments, asking for help, and interacting with each other more effectively. This local success reflects a wider trend across the United States, with 33 states having enacted legislation or policies to restrict student mobile phone use in schools. The push for these restrictions is driven by concerns over the negative impact of smartphones on students' mental health, academic performance, and attention spans. Studies have linked problematic smartphone use to increased depression, anxiety, and insomnia in teenagers, reinforcing the rationale behind these school policies.
The Independent
14 minutes ago
- The Independent
RFK Jr. says he finds it ‘convenient' to wear jeans to the gym
Robert F. Kennedy Jr. explained on Fox News that he works out in jeans for convenience, as he would go hiking before the gym and found it practical. Kennedy recently participated in the 'Pete and Bobby Challenge' with Defense Secretary Pete Hegseth, completing 50 pull-ups and 100 push-ups in under six minutes while wearing jeans. The challenge aims to encourage American youth to be fit, aligning with Kennedy's 'Make America Healthy Again' (MAHA) agenda, which promotes public health, reducing artificial food additives, and re-evaluating health choices for children. Kennedy's MAHA movement, which echoes President Donald Trump 's 'Make America Great Again' slogan, focuses on health issues, including a reassessment of childhood vaccines. While experts agree with Kennedy's claim about increasing chronic conditions in American children, critics like John Oliver and health experts have raised concerns about the 'dangerous' nature of some of MAHA's proposed solutions, particularly the defunding of mRNA vaccine research.
Reuters
2 hours ago
- Reuters
At least 600 US CDC employees are getting final termination notices, AP reports
Aug 20 (Reuters) - At least 600 employees of the U.S. Centers for Disease Control and Prevention are receiving permanent termination notices, the Associated Press reported on Wednesday, citing the American Federation of Government Employees. The report added that the notices were sent out this week, and many employees have not yet received them, according to the union, which represents more than 2,000 dues-paying members at the agency. The Trump administration began mass layoffs of 10,000 staffers at U.S. health agencies in April, as part of a sweeping overhaul aimed at shrinking the federal government and reducing spending. The U.S. Department of Health and Human Services, which oversees the CDC, and the American Federation of Government Employees did not immediately respond to Reuters' requests for comment.
