<div class="bodyItems-wrapper"> WASHINGTON (AP) — The Food and Drug Administration said Friday it will add a new warning and other limitations to a <a href="https://apnews.com/article/sarepta-death-patient-duchennes-muscular-dystrophy-7ee6fc7b1e5e70667c638b598145a5f9" rel="nofollow noopener" target="_blank" data-ylk="slk:gene therapy for Duchenne’s muscular dystrophy;elm:context_link;itc:0;sec:content-canvas" class="link ">gene therapy for Duchenne’s muscular dystrophy</a> that's been linked to <a href="https://apnews.com/article/sarepta-muscular-dystophy-duchennes-gene-therapy-255d04aa3db9bd171c9bf006328ba5d3" rel="nofollow noopener" target="_blank" data-ylk="slk:two patient deaths;elm:context_link;itc:0;sec:content-canvas" class="link ">two patient deaths</a>. The infused therapy from Sarepta Therapeutics will carry a boxed warning — the most serious type — alerting doctors and patients to the risk of potentially fatal liver failure with the treatment, the FDA said in a release. The one-time therapy, Elevidys, has been under <a href="https://apnews.com/article/sarepta-muscular-dystophy-death-fda-gene-therapy-756b7ef43591b685fc197d6acb29c4c1" rel="nofollow noopener" target="_blank" data-ylk="slk:FDA scrutiny;elm:context_link;itc:0;sec:content-canvas" class="link ">FDA scrutiny</a> since the company reported the first of two deaths of teenage boys in March. Following a second death reported in June, the FDA briefly called for halting all shipments of the drug. But the agency quickly <a href="https://apnews.com/article/sarepta-muscular-dystophy-death-fda-gene-therapy-0cab4d676c93f679b7b35d9830b2b57d" rel="nofollow noopener" target="_blank" data-ylk="slk:reversed course;elm:context_link;itc:0;sec:content-canvas" class="link ">reversed course</a> after facing pushback from patient families and <a href="https://apnews.com/article/vinay-prasad-fda-vaccines-laura-loomer-83030ad6eb7651095e3c40444dd69f12" rel="nofollow noopener" target="_blank" data-ylk="slk:libertarian activists;elm:context_link;itc:0;sec:content-canvas" class="link ">libertarian activists</a> close to President Donald Trump. Elevidys is the first U.S.-approved <a href="https://apnews.com/article/fda-gene-therapy-duchenne-muscular-dystrophy-approval-82a82cfb67ef9fb6cf75cd3b5865c138" rel="nofollow noopener" target="_blank" data-ylk="slk:gene therapy;elm:context_link;itc:0;sec:content-canvas" class="link ">gene therapy</a> for Duchenne’s muscular dystrophy, a fatal muscle-wasting disease that affects boys and young men. In addition to the boxed warning, the FDA is also limiting the drug's approved use to patients who are 4 years old and up and can still walk. Previously the FDA had allowed the drug's use in immobile patients, who generally have more advanced disease. New labeling will also recommend weekly liver function monitoring for the first three months of treatment, as well as other precautionary steps. Elevidys is Sarepta's best-selling product and recent headwinds against the drug have weighed heavily on the company and its stock. In July, the Cambridge, Massachusetts-based company announced it would lay off 500 employees. Sarepta Therapeutics Inc. shares rose 7.7% in trading after the FDA announcement, reflecting improved visibility for investors about the company's outlook. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. </div>

The Food and Drug Administration said Friday it will add a new warning and other limitations to a gene therapy for Duchenne’s muscular dystrophy that's been linked to two patient deaths.  The infused therapy from Sarepta Therapeutics will carry a boxed warning — the most serious type — alerting doctors and patients to the risk of potentially fatal liver failure with the treatment, the FDA said in a release.  The one-time therapy, Elevidys, has been under FDA scrutiny since the company reported t

FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths

James Webb Space telescope spots 'big red dot' in the ancient universe: A ravenous supermassive black hole named 'BiRD'

The foreign ministers of France, Germany, and Italy decried the Iranian regime's crackdown on protestors as "unbearable and inhumane," "brutal," and "absolutely unacceptable. " The foreign ministries of France, Germany, and Italy summoned their nation’s Iranian ambassadors on Tuesday, as worldwide concern spreads over the Iranian regime’s treatment of domestic protests.

France, Germany, Italy summon Iranian envoys over 'unbearable, inhumane' regime crackdown

One of 153 Palestinians who left Gaza without knowing the final destination, says Israel helped facilitate transfer.

‘Trip of suffering’: Gaza evacuee details 24-hour journey to South Africa

Perfect gems pieces are immortal fortunes that dazzle with their brightness, craftsmanship, and history. From astonishing precious stones to dynamic hued


The Magnificence of Extraordinariness: Presenting Valuable Adornments and Gemstones


In 2024, the universe of sound innovation keeps on pushing the limits of sound quality, plan, and client experience. Whether


Experience Unrivaled Sound: Top Speakers You Really want to Hear


At any point had a film night where you invested more energy looking at titles than really watching a film? Or on the other hand perhaps


7 Fun Plans to Make Film Evenings Seriously Invigorating (You'll Cherish #5!)


Picking a favored kind of craftsmanship is a profoundly private choice that reflects individual preferences, close to home reactions, and stylish inclinations.


Vote in favor of your Favored kind of craftsmanship


In the present quick moving and advanced world, versatile applications have become significant apparatuses for supporting emotional well-being and prosperity. These applications


The Best Portable Applications for Emotional wellness and Prosperity


In the present computerized age, having a shocking and practical site is fundamental for organizations, business visionaries, and people to lay out their


The most effective method to Make a Dazzling Site in 5 Basic Advances


Overseeing individual budgets is a urgent expertise for accomplishing monetary dependability and getting your future. This fundamental aide will give


Dominating Your Cash: The Fundamental Manual for Overseeing Individual accounting records


Since the beginning of time, workmanship has enraptured and propelled individuals across societies and ages. Certain fine arts have risen above their time and become


The 10 Most Famous Works of art Ever


The craft of handshaking is a well established practice that rises above societies and keeps on being a crucial interactive ability in


The most effective method to Consummate the Specialty of Handshaking in Business and Group environments


Investigating China offers voyagers an opportunity to encounter a rich embroidery of history, culture, and normal excellence. From antiquated milestones


Finding China: Four Urban areas for a Remarkable Excursion


Given the Lego Group's multi-year partnership with the Pokémon Company, which was initially announced last March, fans expect that even more Pokémon sets will become available.