FDA
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
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A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.
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The FDA’s decision is based on favorable results from Sanofi’s Phase III CARDINAL trial, a 26-week open label, single arm study on 24 CAD patients.
Gilead Sciences revealed in a call with analysts that the hold has now been expanded to additional magrolimab studies.
Recent FDA approval of ViiV Healthcare’s HIV treatment Cabenuva reduced dosing to once every two months.
Novavax is finally submitting an Emergency Use Authorization request to the U.S. Food and Drug Administration for its COVID-19 vaccine candidate, NVX-CoV2373, a protein-based vaccine.
The FDA’s decision is based on positive results from several Phase III studies, including the TENAYA and LUCERNE clinical trials.
The FDA approved Kimmtrak for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma (mUM).
The FDA cited data demonstrating that both treatments are not likely to be potent against omicron and should not be authorized for use in any U.S. state, territory, and jurisdiction for the time being.
It’s a landmark no one expected or wanted — more than 70 million confirmed COVID-19 cases in the U.S. with 866,000 deaths. For that and more COVID-19 news, continue reading.
The U.S. Food and Drug Administration has approved SKYRIZI (risankizumab-rzaa), AbbVie’s proposed treatment for adults diagnosed with active psoriatic arthritis (PsA).
After receiving daily doses of the therapeutic, 71% of the children could tolerate the equivalent of 16 peanuts and six months later, 21% of them still could.