The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive. Sarepta last month paused shipments for certain older Duchenne patients following the death from acute liver failure of a second teenager treated with the therapy, called Elevidys. The …
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Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says – Reuters
Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says Reuters Sarepta shares plunge 40% as future of its gene therapy appears at risk CNBC FDA to Ask Sarepta to Stop Shipping Muscular Dystrophy Drug Elevidys The New York Times Third death from a Sarepta gene therapy BioCentury FDA Is Investigating If Sarepta’s Gene Therapy Should Stay on Market Bloomberg …
Read More »Sarepta stock falls on FDA gene therapy Elevidys comment
Douglas Ingram, president and chief executive officer of Sarepta Therapeutics Inc., during the Forbes Healthcare Summit in New York, US, on Tuesday, Dec. 5, 2023. Michael Nagle | Bloomberg | Getty Images Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy treatment appeared at risk. The Food and Drug Administration will …
Read More »FDA panel backs menopausal hormone therapy – Axios
FDA panel backs menopausal hormone therapy Axios F.D.A. Panelists Call for Removal of Warnings on Menopause Treatments The New York Times FDA chief: HRT warning among ‘greatest mistakes of modern medicine’ NewsNation FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women fda.gov US could scrap health warnings on HRT The Telegraph Source link
Read More »Sarepta Says Another Patient Died After Receiving Gene Therapy – Bloomberg
Sarepta Says Another Patient Died After Receiving Gene Therapy Bloomberg Patient dies in Sarepta gene therapy trial, adding to safety concerns STAT Sarepta Therapeutics lays off one-third of workforce in drastic cost-cutting The Boston Globe Third death from a Sarepta gene therapy BioCentury Sarepta Therapeutics Stock Is Surging After The Bell: What’s Going On? Yahoo Finance Source link
Read More »F.D.A. Panel to Reassess Hormone Therapy Warnings – The New York Times
F.D.A. Panel to Reassess Hormone Therapy Warnings The New York TimesView Full Coverage on Google News Source link
Read More »Sarepta to cut 500 jobs, add black-box warning on gene therapy – Reuters
Sarepta to cut 500 jobs, add black-box warning on gene therapy Reuters Sarepta Therapeutics Announces Strategic Restructuring and Pipeline Prioritization Plan to Maintain Long-term, Sustainable Growth and Provides Update on ELEVIDYS Label Sarepta Therapeutics Sarepta Soars as Gene Therapy Stays on Market With Warning Bloomberg Sarepta pivots to siRNA and lays off 500 staffers as Elevidys gets box warning Fierce Biotech Sarepta Therapeutics Halts …
Read More »Sarepta Soars as Gene Therapy Stays on Market With Warning – Bloomberg
Sarepta Soars as Gene Therapy Stays on Market With Warning Bloomberg Sarepta Therapeutics Announces Strategic Restructuring and Pipeline Prioritization Plan to Maintain Long-term, Sustainable Growth and Provides Update on ELEVIDYS Label Sarepta Therapeutics Sarepta pivots to siRNA and lays off 500 staffers as Elevidys gets box warning Fierce Biotech Sarepta Therapeutics Halts ELEVIDYS Shipments for Non-Ambulatory DMD Patients Yahoo Finance Sarepta Therapeutics lays off …
Read More »Hormone therapy supercharges tirzepatide, unleashing major weight loss after menopause
Using tirzepatide and menopause hormone therapy at the same time leads to increased weight loss in postmenopausal women with overweight or obesity compared to use of tirzepatide treatment alone, according to a study presented at ENDO 2025, the Endocrine Society’s annual meeting in San Francisco, Calif. “These data are the first to show the combined use of tirzepatide and menopause …
Read More »Study warns of ‘significant risks’ in using AI therapy chatbots
Therapy chatbots powered by large language models may stigmatize users with mental health conditions and otherwise respond inappropriately or even dangerously, according to researchers at Stanford University. While recent coverage in The New York Times and elsewhere has highlighted the role that ChatGPT may play in reinforcing delusional or conspiratorial thinking, a new paper titled “Expressing stigma and inappropriate responses …
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