FDA
Jefferies analysts envision a steady launch curve that could ultimately drive meaningful sales from people who are dissatisfied with existing treatments.
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Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
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Sometimes the U.S. Food and Drug Administration (FDA) runs ahead of schedule. In the case of this week’s two PDUFA dates, that was completely true. Here’s a look.
There were a fair number of clinical trial announcements last week. Here’s a look.
The approval was built on data from the Phase III ASPEN trial that compared Brukinsa to ibrutinib in a total of 201 patients. Here’s more about the drug.
FDA greenlit Janssen’s Invega Hafyera, the first long-acting antipsychotic drug of its kind that provides six months’ control of symptoms with a single dose.
Mesoblast shares dropped on the last day of August 2021 after it was told that its candidate COVID-19 treatment needs to undergo another trial to be green-lit for emergency approval by the FDA.
FDA approved Ascendis Pharma’s Skytrofa for children one year and older who have growth failure from inadequate secretion of endogenous growth hormone.
Less than 10 days after the FDA slammed Sesen bladder cancer drug with a CRL, the company has withdrawn its Marketing Application Authorization from the European Union.
The new authorization is expected to be the final reassurance for many of those who had hesitated when the vaccine was approved under emergency use only.
The FDA has approved the use of the injectable drug KORSUVA in treating moderate to severe pruritus in adult patients undergoing hemodialysis for chronic kidney disease.
Many expect the full approval will lead to vaccine mandates, as that was one of the obstacles to it for many organizations.