FDA
Wegovy is the first and only once-weekly GLP-1 receptor agonist that’s been approved for weight control in people living with obesity. This is the same drug used to treat type 2 diabetes.
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A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
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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.
Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia are life-threatening hospital-related pulmonary infections that can particularly impact patients who are already dealing with severe underlying medical conditions.
Here’s a look at what’s on the U.S. Food and Drug Administration’s calendar for the next two weeks.
Medtronic plc announced U.S. Food and Drug Administration clearance and commercial launch for the SelectSite C304-HIS deflectable catheter system for use in procedures involving His-bundle pacing.
The U.S. Food and Drug Administration approved Celgene’s Revlimid (lenalidomide) in combination with a rituximab product for adults with previously treated follicular lymphoma or marginal zone lymphoma. It is the first FDA-approved combination therapy for patients with these forms of non-Hodgkin’s lymphoma that doesn’t include chemotherapy.