Food and Drug Administration (FDA)
NEWS
Although the weekend was filled with news out of the American Society of Clinical Oncology Annual Meeting, here’s a roundup of some of the top clinical trial news from earlier last week.
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.
Here’s a preview of just a handful of opportunities, companies and speakers and what they’re presenting.
The collaboration will establish a study protocol with an initial focus on breast cancer to provide the regulatory agency with information on the evolving treatment landscape, including insight on treatment variation within defined subpopulations of patients with the disease.
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.
There are approximately 11 million adults in the U.S. living with bipolar disorder, a condition that causes extreme shifts in mood, energy and activity levels.
The approval of Piqray combined with fulvestrant is the first FDA-approved treatment for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer.
The agency expressed concern over the results of recently finished studies in rats and dogs that showed central nervous system events that might have implications in humans.
The approval of Jakafi marks the first approved treatment for this indication in the United States.
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