Regulatory
Steve Hoerter, president and chief executive officer of Deciphera, said the acceptance of the NDA brings the company one step closer to its goal of providing a new treatment option for patients with advanced GIST.
A number of new medications stand a shot at early regulatory approval thanks to the U.S. Food and Drug Administration’s priority review program.
In November 2019, the U.S. Food and Drug Administration (FDA) released new draft guidance that would help generic drug companies bring biosimilars to insulin to the market more quickly.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are reports that two of the three primary biopharma companies that sell insulin in the U.S. are trying to change that draft guidance.
While fears of a potential coronavirus or flu pandemic continue to grow across the globe, the White House is calling for a 16% cut to the budget of the U.S. Centers for Disease Control, as well as a 10% cut to the Department of Health and Human Services.
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.
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