Regulatory
The U.S. FDA had a very packed calendar for this week, but almost everything on it was under a Priority Review pathway.
The FDA indicated the drug couldn’t be approved in its present form and asked for another clinical trial of the drug be run before they reapplied.
The hold is related to a report of a SUSAR of myelodysplastic syndrome in a patient treated with eli-cel, also known as Lenti-D, in a Phase III clinical trial.
The company indicated they plan to meet with the FDA to determine the next course of action.
As COVID-19 vaccines near full approval by the U.S. FDA, Dr. Anthony Fauci expects several organizations across the country, including businesses and schools, will issue their own vaccine mandates before people can enter their establishments.
Although August is a fairly busy month for PDUFA dates, there were only two on the U.S. FDA’s calendar for this week, and one of those has already been reported. Here’s a look.
It was a busy week for clinical trial announcements. Take a look.
Specifically, the FDA states Syntec has critical issues with how the pharmaceutical manufacturer handles active pharmaceutical ingredients, issues that may compromise the safety of the firm’s manufactured drugs.
The FDA-initiated partial hold on Novartis’ gene therapy trial for spinal muscular atrophy has been lifted recently. Here’s everything you need to know about it.
Seventeen years after buying global rights, AstraZeneca is finally announcing a win for the lupus community with an FDA approval for Saphnelo.
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