March 21 (Reuters) - The U.S. health regulator on Thursday classified the recall of some Impella Left Sided Blood Pumps by Abiomed, a Johnson & Johnson company, as the most serious and said that its use could cause serious injuries or death. (Reporting by Bhanvi Satija in Bengaluru; Editing by Anil D'Silva)
These stocks have tremendous potential, and it doesn't depend on the growth prospects for artificial intelligence.
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Friday, the FDA approved Pfizer Inc’s (NYSE:PFE) Beqvez (fidanacogene elaparvovec-dzkt) for moderate to severe hemophilia B in adult patients who currently use factor IX (FIX) prophylaxis therapy or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var capsid. Beqvez is a one-time treatment designed to enable hemophilia B patients to produce FIX themselves
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The FDA approved Pfizer's hemophilia gene therapy on Friday. But Pfizer stock only inched ahead on the approval early Friday.
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Pfizer has received approval from the Food and Drug Administration for a rare genetic bleeding disorder treatment—the drug-maker’s first gene therapy to be approved in the U.S. The treatment, Beqvez, is for adults with moderate to severe hemophilia B—a disorder that prevents normal blood clotting—and will be available by prescription to eligible patients this quarter, according to the company. “Many people with hemophilia B struggle with the commitment and lifestyle disruption of regular FIX infusions, as well as spontaneous bleeding episodes, which can lead to painful joint damage and mobility issues,” said Adam Cuker, director of University of Pennsylvania’s Comprehensive Hemophilia and Thrombosis Program.