FDA
Clinical data showed Dupixent reduces nasal polyp size, improves congestion and loss of smell, while reducing the need for surgery and systemic corticosteroids.
The Complete Response Letter indicated the company will need to run an “adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vEDS.”
July looks to be a quiet month for the U.S. Food and Drug Administration (FDA), and it sure looks like the agency is trying to get a lot of work done before the July 4 holiday. Here’s a look at the many approvals scheduled for this week.
Allergan announced that the U.S. Food and Drug Administration has approved its wrinkle treatment Botox for children with upper limb spasticity. The news comes just days after rumors that the company may break up.
The approval marks the first glucagon-like peptide-1 (GLP-1) receptor agonist approved for children and adolescents with type 2 diabetes.
June is turning out to be a busy month for approvals for the U.S. Food and Drug Administration. The agency has a slate of PDUFA dates this week, including two for Merck alone. Here’s a look.
The Dutch company Xenikos B.V. announced that the U.S. Food and Drug Administration has approved an investigational new drug application to initiate a U.S.-based clinical Phase 3 registration trial in order to test the efficacy of T-Guard for treating steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.
Data from the clinical study showed that 40% of people treated with the Polivy regimen achieved a complete response.
The approval was built on data from the Phase III KEYNOTE-048 clinical trial.
The approval marks Emgality as the first calcitonin gene-related peptide (CGRP) antibody to be approved for two distinct headache disorders.
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