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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.
The FDA recommended additional clinical and statistical data analyses of Vicineum, as well as issues related to the company’s Chemistry, Manufacturing, and Controls.
The Canadian biotech announced the acquisition of two new pipeline assets that align with its focus on autoimmune and kidney-related disease.
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.
This approval makes TICOVAC the only FDA-backed vaccine in the U.S. to protect people of all ages against the virus when visiting or living in TBE endemic regions.
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.
Merck’s Welireg won FDA approval for adult patients with von Hippel-Lindau disease who require therapy for associated RCC, central nervous system, and hemangioblastomas.
The U.S. FDA had a very packed calendar for this week, but almost everything on it was under a Priority Review pathway.
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