FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
FEATURED STORIES
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
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.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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The FDA stated that it could not determine if the use of lenzilumab in COVID patients outweighs the known and potential safety risks.
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Less than 10 days after the FDA slammed Sesen bladder cancer drug with a CRL, the company has withdrawn its Marketing Application Authorization from the European Union.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.