Regulatory
Specifically, the new approval was for adults with dMMR recurrent or advanced solid tumors who have progressed on or after previous treatment and who have no satisfactory alternatives.
As COVID-19 surges to earlier pandemic levels in the U.S., federal health officials are expected to authorize a third booster shot eight months after receiving the second of the Moderna and Pfizer-BioNTech vaccines, and probably the Johnson & Johnson vaccine as well.
As the COVID-19 pandemic continues with surges in the U.S. in unvaccinated people, biopharma companies are still working on new vaccines and therapies against the disease.
Patient enrollment in the Phase I study will resume, the company announced this morning.
Two experimental cancer drugs, one for ovarian cancer and one for a form of breast cancer, received Fast Track designation from the U.S. FDA, which will speed up the regulatory process for these medications.
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.
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