Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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RRP is a rare, potentially fatal orphan disease caused by the Human Papillomavirus (HPV), a common virus present in 80 percent of people worldwide
A single AQP5+ human gastric stem cell gives rise to a 3D gastric organoid that re-expresses AQP5.
In an analysis of the proposal, Regulatory Focus, the publication of the Regulatory Affairs Professional Society, noted that the FDA, under the proposal, could see $6.2 billion in overall funding.
The FDA gave tentative approval for the drug in 2018, but the holdup was over patent issues.
The company disclosed late Monday that the U.S. Food and Drug Administration placed a clinical hold on its proposed gene therapy treatment for methylmalonic academia.
Linshom announced U.S. Food and Drug Administration 510 clearance of the company’s first product, a small, non-invasive respiratory monitor that addresses the growing need for continuous respiratory monitoring for patients susceptible to respiratory depression and compromise.
“The FDA filing acceptance for Libervant is an important milestone in our mission to provide epilepsy patients with a broader array of treatment options, that represent major contributions to patient care,” said Keith J. Kendall, Aquestive’s chief executive officer.
Myovant to Seek Regulatory Approval of Uterine Fibroid Treatment Following Positive Late-Stage Trial
More than five million women suffer from symptoms of uterine fibroids, with more than half of them estimated to have received inadequate treatment. However, new data released by Myovant shows that concerns of inadequate treatment could soon change.
A four-year-old legal battle between Agilent Technologies and Twist Bioscience came to a conclusion Thursday. Twist agreed to pay Agilent $22.5 million to settle the lawsuit filed in 2016.
Pharma and life science companies from across the globe provide updates on their pipelines and businesses.