Approvals
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.
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 approval of Jakafi marks the first approved treatment for this indication in the United States.
The price of the one-and-done gene therapy treatment is about half of what was initially projected by Novartis.
Shares of NovoCure are up more than 6% in premarket trading after the company announced it won regulatory approval for its mesothelioma treatment, NovoTTF-100L System.
Sorilux was approved for the treatment of patients age 12 and up.
The FDA approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) as the first treatments for transthyretin-meditated amyloidosis.
The FDA extended the indication for Gattex to pediatric patients one year of age and older with short bowel syndrome.
PRESS RELEASES