Food and Drug Administration (FDA)
NEWS
The therapy was also granted Rare Pediatric Disease designation for neuronopathic Gaucher disease, the most severe form of the condition.
In November 2019, the U.S. Food and Drug Administration (FDA) released new draft guidance that would help generic drug companies bring biosimilars to insulin to the market more quickly. And now there are reports that two of the three primary biopharma companies that sell insulin in the U.S. are trying to change that draft guidance.
RRP is a rare, potentially fatal orphan disease caused by the Human Papillomavirus (HPV), a common virus present in 80 percent of people worldwide
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.
Although it was a relatively slow week for clinical trial updates, there were still a number of announcements. Here’s a look.
JOBS
IN THE PRESS