The FDA has approved new safety warnings and a revised indication for Elevidys following multiple reports of fatal acute liver failure in non-ambulatory patients with DMD.
Here are the violations reported in food safety inspection reports from Montgomery County conducted the week of Nov. 9-15, ...
A rare meat allergy called Alpha-gal syndrome is on the rise in the United States. This condition is caused by tick bites, ...
The FDA updated prescribing information for Elevidys with new safety warnings and limiting its use to DMD patients who can ...
DuBreton, a Canadian organic pork producer, is urging food brands, grocery retailers and supply chain partners to voluntarily disclose information on genetically modified (GM) pork and beef, as Health ...
Sarepta must also run a post-marketing study for Elevidys to better assess the risk of serious liver injury in patients dosed ...
With their promise to transform disease trajectories, cell and gene therapies (CGTs) are bringing new hope to patients with ...
Researchers have documented the first fatality due to alpha-gal syndrome after consumption of mammalian meat, according to ...
In both fatal cases, patients developed markedly elevated liver enzymes and required hospitalization within two months of Elevidys infusion. An additional serious, non-fatal case of acute liver injury ...
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced an ...
The updated label now includes a boxed warning and a new “limitation of use" in addition to the removal of the prior ...
The U.S. Food and Drug Administration today announced it is taking action to approve new labeling submitted by the company that ...
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