{"id":4111,"date":"2025-07-16T17:52:36","date_gmt":"2025-07-16T14:52:36","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4111"},"modified":"2025-07-16T18:11:10","modified_gmt":"2025-07-16T15:11:10","slug":"fda-rejection-letter-vyondys-53-golodirsen","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/hi\/fda-rejection-letter-vyondys-53-golodirsen\/","title":{"rendered":"\u0935\u094d\u092f\u094b\u0902\u0921\u093f\u0938 53: FDA \u0905\u0938\u094d\u0935\u0940\u0915\u0943\u0924\u093f \u092a\u0924\u094d\u0930 \u0915\u093e \u0915\u094d\u092f\u093e \u0905\u0930\u094d\u0925 \u0939\u0948?"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u0916\u093e\u0926\u094d\u092f \u090f\u0935\u0902 \u0914\u0937\u0927\u093f \u092a\u094d\u0930\u0936\u093e\u0938\u0928 \u0928\u0947 \u0917\u0941\u0930\u0941\u0935\u093e\u0930 \u0915\u094b \u0926\u0935\u093e\u0913\u0902 \u0915\u0947 \u0905\u0938\u094d\u0935\u0940\u0915\u0943\u0924 \u0939\u094b\u0928\u0947 \u0915\u0947 \u092c\u093e\u0926 \u0915\u0902\u092a\u0928\u093f\u092f\u094b\u0902 \u0915\u094b \u092d\u0947\u091c\u0947 \u0917\u090f 200 \u0938\u0947 \u0905\u0927\u093f\u0915 \u092a\u0924\u094d\u0930\u094b\u0902 \u0915\u094b \u092a\u094d\u0930\u0915\u093e\u0936\u093f\u0924 \u0915\u093f\u092f\u093e, \u091c\u093f\u0938\u0938\u0947 \u0926\u0935\u093e \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e \u0915\u0947 \u0915\u092d\u0940-\u0915\u092d\u0940 \u0928\u091c\u0930\u0905\u0902\u0926\u093e\u091c \u0915\u093f\u090f \u091c\u093e\u0928\u0947 \u0935\u093e\u0932\u0947 \u0939\u093f\u0938\u094d\u0938\u0947 \u0915\u0940 \u0913\u0930 \u0927\u094d\u092f\u093e\u0928 \u0906\u0915\u0930\u094d\u0937\u093f\u0924 \u0939\u0941\u0906\u0964 <strong>\u0907\u0928\u092e\u0947\u0902 \u0938\u0947 \u090f\u0915 \u0905\u0938\u094d\u0935\u0940\u0915\u0943\u0924\u093f \u092a\u0924\u094d\u0930 \u0935\u094d\u092f\u094b\u0902\u0921\u093f\u0938 53 (\u0917\u094b\u0932\u094b\u0921\u093f\u0930\u0938\u0947\u0928) \u0915\u0947 \u0932\u093f\u090f \u092d\u0947\u091c\u093e \u0917\u092f\u093e \u0925\u093e, \u091c\u094b Sarepta Therapeutics \u0926\u094d\u0935\u093e\u0930\u093e \u0928\u093f\u0930\u094d\u092e\u093f\u0924 \u0914\u0930 \u090f\u0915\u094d\u0938\u0949\u0928 53 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0925\u0947\u0930\u0947\u092a\u0940 \u0915\u0947 \u0932\u093f\u090f \u0935\u093f\u0915\u0938\u093f\u0924 \u0926\u0935\u093e \u0939\u0948\u0964<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u090f\u091c\u0947\u0902\u0938\u0940 \u0928\u0947 \u0915\u0947\u0935\u0932 \u0909\u0928 \u0928\u093f\u0930\u094d\u092e\u093e\u0924\u093e\u0913\u0902 \u0915\u094b \u0932\u093f\u0916\u0947 \u092a\u0924\u094d\u0930\u094b\u0902 \u092a\u0930 \u0927\u094d\u092f\u093e\u0928 \u0915\u0947\u0902\u0926\u094d\u0930\u093f\u0924 \u0915\u093f\u092f\u093e \u091c\u093f\u0928\u0915\u0947 \u0909\u0924\u094d\u092a\u093e\u0926\u094b\u0902 \u0915\u094b \u0905\u0902\u0924\u0924\u0903 \u0938\u094d\u0935\u0940\u0915\u0943\u0924\u093f \u092e\u093f\u0932 \u0917\u0908, \u0914\u0930 \u091c\u093f\u0928\u092e\u0947\u0902 \u0938\u0947 \u0905\u0927\u093f\u0915\u093e\u0902\u0936 \u0909\u0924\u094d\u092a\u093e\u0926 \u0935\u0930\u094d\u0937\u094b\u0902 \u092a\u0939\u0932\u0947 \u0939\u0940 \u091c\u093e\u0930\u0940 \u0915\u093f\u090f \u091c\u093e \u091a\u0941\u0915\u0947 \u0925\u0947\u0964 \u0938\u092d\u0940 \u092a\u0924\u094d\u0930\u094b\u0902 \u0915\u094b \u090f\u0915 \u091c\u0917\u0939 \u090f\u0915\u0924\u094d\u0930\u093f\u0924 \u0915\u0930\u0915\u0947, \u090f\u091c\u0947\u0902\u0938\u0940 \u0928\u0947 \u0926\u093e\u0935\u093e \u0915\u093f\u092f\u093e \u0915\u093f \u092f\u0939 \u0917\u0924\u093f\u0935\u093f\u0927\u093f \u092a\u093e\u0930\u0926\u0930\u094d\u0936\u093f\u0924\u093e \u0915\u094b \u092c\u0922\u093c\u093e\u0935\u093e \u0926\u0947\u0928\u0947 \u0915\u0947 \u0935\u094d\u092f\u093e\u092a\u0915 \u092a\u094d\u0930\u092f\u093e\u0938 \u0915\u093e \u090f\u0915 \u0939\u093f\u0938\u094d\u0938\u093e \u0925\u0940\u0964<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u0935\u093f\u0937\u092f\u0938\u0942\u091a\u0940<\/h2><nav><ul><li><a href=\"#details-of-fda-rejection-letter-about-vyondys-53\">FDA \u0905\u0938\u094d\u0935\u0940\u0915\u0943\u0924\u093f \u092a\u0924\u094d\u0930 \u0915\u093e \u0935\u093f\u0935\u0930\u0923 Vyondys 53 \u0915\u0947 \u092c\u093e\u0930\u0947 \u092e\u0947\u0902<\/a><\/li><li><a href=\"#dystrophin-level-increased-9-parts-in-a-thousand\">\u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u0915\u093e \u0938\u094d\u0924\u0930 \u090f\u0915 \u0939\u091c\u093e\u0930 \u092e\u0947\u0902 9 \u092d\u093e\u0917\u094b\u0902 \u0924\u0915 \u092c\u0922\u093c \u0917\u092f\u093e<\/a><\/li><li><a href=\"#clinical-effect-of-vyondys-53\">\u0935\u094d\u092f\u094b\u0902\u0921\u093f\u0938 53 \u0915\u093e \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u092a\u094d\u0930\u092d\u093e\u0935<\/a><\/li><li><a href=\"#serious-side-effects-of-vyondys-53-according-to-the-fda\">FDA \u0915\u0947 \u0905\u0928\u0941\u0938\u093e\u0930, \u0935\u094d\u092f\u094b\u0902\u0921\u093f\u0938 53 \u0915\u0947 \u0917\u0902\u092d\u0940\u0930 \u0926\u0941\u0937\u094d\u092a\u094d\u0930\u092d\u093e\u0935<\/a><\/li><li><a href=\"#how-was-vyondys-53-approved\">\u0935\u094d\u092f\u094b\u0902\u0921\u093f\u0938 53 \u0915\u094b \u0915\u0948\u0938\u0947 \u092e\u0902\u091c\u0942\u0930\u0940 \u0926\u0940 \u0917\u0908?<\/a><\/li><li><a href=\"#pharmaceutical-companies-dont-publish-all-information\">\u0926\u0935\u093e \u0915\u0902\u092a\u0928\u093f\u092f\u093e\u0901 \u0938\u092d\u0940 \u091c\u093e\u0928\u0915\u093e\u0930\u0940 \u092a\u094d\u0930\u0915\u093e\u0936\u093f\u0924 \u0928\u0939\u0940\u0902 \u0915\u0930\u0924\u0940\u0902<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"details-of-fda-rejection-letter-about-vyondys-53\">FDA \u0905\u0938\u094d\u0935\u0940\u0915\u0943\u0924\u093f \u092a\u0924\u094d\u0930 \u0915\u093e \u0935\u093f\u0935\u0930\u0923 Vyondys 53 \u0915\u0947 \u092c\u093e\u0930\u0947 \u092e\u0947\u0902<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">FDA \u0928\u0947 \u0921\u094d\u092f\u0942\u091a\u0947\u0928 \u092e\u0938\u094d\u0915\u0941\u0932\u0930 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u0949\u092b\u0940 \u0915\u0947 \u0932\u093f\u090f \u090f\u0915\u094d\u0938\u0949\u0928 53-\u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0909\u092a\u091a\u093e\u0930, \u0935\u094d\u092f\u094b\u0902\u0921\u093f\u0938 53 (\u0917\u094b\u0932\u094b\u0921\u093f\u0930\u0938\u0947\u0928) \u0915\u0947 \u0932\u093f\u090f \u0905\u092a\u0928\u093e 2019 \u0905\u0938\u094d\u0935\u0940\u0915\u0943\u0924\u093f \u092a\u0924\u094d\u0930 \u091c\u093e\u0930\u0940 \u0915\u093f\u092f\u093e\u0964 <strong>FDA \u0928\u0947 \u0915\u0939\u093e \u0915\u093f \u0909\u092a\u091a\u093e\u0930 \u0926\u094d\u0935\u093e\u0930\u093e \u092a\u094d\u0930\u0926\u093e\u0928 \u0915\u0940 \u0917\u0908 \u201c\u0936\u0949\u0930\u094d\u091f\u0947\u0921 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u0915\u0947 \u0938\u094d\u0924\u0930 \u092e\u0947\u0902 \u092e\u093e\u092e\u0942\u0932\u0940 \u0935\u0943\u0926\u094d\u0927\u093f\u201d \u0915\u094b \u0926\u0947\u0916\u0924\u0947 \u0939\u0941\u090f, \u0935\u094d\u092f\u094b\u0902\u0921\u093f\u0938 53 \u0915\u093e \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u0932\u093e\u092d \u0938\u0902\u092d\u0935\u0924\u0903 \u201c\u0905\u0928\u0941\u092a\u093e\u0924\u093f\u0915 \u0930\u0942\u092a \u0938\u0947 \u091b\u094b\u091f\u093e\u201d \u0939\u094b\u0917\u093e\u0964<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"dystrophin-level-increased-9-parts-in-a-thousand\">\u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u0915\u093e \u0938\u094d\u0924\u0930 \u090f\u0915 \u0939\u091c\u093e\u0930 \u092e\u0947\u0902 9 \u092d\u093e\u0917\u094b\u0902 \u0924\u0915 \u092c\u0922\u093c \u0917\u092f\u093e<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA \u0915\u0947 \u0935\u094d\u092f\u094b\u0902\u0921\u093f\u0938 53 (\u0917\u094b\u0932\u094b\u0921\u093f\u0930\u0938\u0947\u0928) \u0915\u0947 \u0905\u0938\u094d\u0935\u0940\u0915\u0943\u0924\u093f \u092a\u0924\u094d\u0930 \u092e\u0947\u0902 \u0926\u0935\u093e \u0915\u0947 \u0909\u092a\u092f\u094b\u0917 \u0915\u0947 \u092c\u093e\u0926 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u0915\u0947 \u0938\u094d\u0924\u0930 \u092e\u0947\u0902 \u092c\u0939\u0941\u0924 \u092e\u093e\u092e\u0942\u0932\u0940 \u0935\u0943\u0926\u094d\u0927\u093f \u0915\u093e \u0909\u0932\u094d\u0932\u0947\u0916 \u0915\u093f\u092f\u093e \u0917\u092f\u093e \u0925\u093e<\/strong>:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0905\u0927\u094d\u092f\u092f\u0928 \u092e\u0947\u0902 \u0936\u093e\u092e\u093f\u0932 25 \u092e\u0942\u0932\u094d\u092f\u093e\u0902\u0915\u0928 \u092f\u094b\u0917\u094d\u092f \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f, \u0935\u0947\u0938\u094d\u091f\u0930\u094d\u0928 \u092c\u094d\u0932\u0949\u091f \u0926\u094d\u0935\u093e\u0930\u093e \u0906\u0915\u0932\u093f\u0924 \u0906\u0927\u093e\u0930\u092d\u0942\u0924 \u092e\u093e\u0927\u094d\u092f \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093c\u093f\u0928 \u0938\u094d\u0924\u0930 0.10 \u00b1 0.07 (\u0938\u093e\u092e\u093e\u0928\u094d\u092f \u0915\u093e \u092a\u094d\u0930\u0924\u093f\u0936\u0924; \u092e\u093e\u0927\u094d\u092f \u00b1 \u090f\u0938\u0921\u0940) \u0925\u093e\u0964 48\u0935\u0947\u0902 \u0938\u092a\u094d\u0924\u093e\u0939 \u092e\u0947\u0902, \u092e\u093e\u0927\u094d\u092f \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093c\u093f\u0928 \u0938\u094d\u0924\u0930 1.02 \u00b1 1.03 (\u0938\u093e\u092e\u093e\u0928\u094d\u092f \u0915\u093e \u092a\u094d\u0930\u0924\u093f\u0936\u0924; \u092e\u093e\u0927\u094d\u092f \u00b1 \u090f\u0938\u0921\u0940) \u0925\u093e, \u091c\u094b \u0938\u093e\u092e\u093e\u0928\u094d\u092f \u0938\u0947 0.92 \u00b1 1.01 \u092a\u094d\u0930\u0924\u093f\u0936\u0924 \u0915\u0940 \u092e\u093e\u0927\u094d\u092f \u0935\u0943\u0926\u094d\u0927\u093f \u0915\u0947 \u0905\u0928\u0941\u0930\u0942\u092a \u0925\u093e\u0964<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u092e\u0947\u0902 \u0935\u094d\u092f\u0915\u094d\u0924\u093f\u0917\u0924 \u092a\u0930\u093f\u0935\u0930\u094d\u0924\u0928 \u0928\u0940\u091a\u0947 \u091a\u093f\u0924\u094d\u0930 1 \u092e\u0947\u0902 \u090f\u0915 \u0938\u093e\u092e\u093e\u0928\u094d\u092f (100%) \u092a\u0948\u092e\u093e\u0928\u0947 \u0915\u093e \u0909\u092a\u092f\u094b\u0917 \u0915\u0930\u0915\u0947 \u0926\u0930\u094d\u0936\u093e\u090f \u0917\u090f \u0939\u0948\u0902 \u0924\u093e\u0915\u093f \u0906\u0901\u0915\u0921\u093c\u094b\u0902 \u0915\u094b \u0909\u091a\u093f\u0924 \u092a\u0930\u093f\u092a\u094d\u0930\u0947\u0915\u094d\u0937\u094d\u092f \u092e\u0947\u0902 \u0930\u0916\u093e \u091c\u093e \u0938\u0915\u0947 \u0914\u0930 \u092a\u094d\u0930\u092d\u093e\u0935 \u0906\u0915\u093e\u0930 \u0915\u094b \u092c\u0922\u093c\u093e-\u091a\u0922\u093c\u093e\u0915\u0930 \u092a\u0947\u0936 \u0928 \u0915\u093f\u092f\u093e \u091c\u093e \u0938\u0915\u0947\u0964 \u0906\u092a\u0928\u0947 \u0926\u0947\u0916\u093e \u0939\u094b\u0917\u093e \u0915\u093f \u090f\u0915\u094d\u0938\u0949\u0928 53 \u0914\u0930 \u090f\u0915\u094d\u0938\u0949\u0928 51 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0915\u0947 \u0905\u0928\u0941\u0915\u0942\u0932 \u0909\u0924\u094d\u092a\u0930\u093f\u0935\u0930\u094d\u0924\u0928 \u0935\u093e\u0932\u0947 \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u092e\u0947\u0902, \u0915\u094d\u0930\u092e\u0936\u0903 \u0917\u094b\u0932\u094b\u0921\u093f\u0930\u094d\u0938\u0947\u0928 \u0914\u0930 \u090f\u091f\u0947\u092a\u094d\u0932\u093f\u0930\u094d\u0938\u0947\u0928 \u0915\u0940 \u092a\u094d\u0930\u0924\u093f\u0915\u094d\u0930\u093f\u092f\u093e \u092e\u0947\u0902 \u091f\u094d\u0930\u0902\u0915\u0947\u091f\u0947\u0921 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u092e\u0947\u0902 \u0914\u0938\u0924 \u0935\u0943\u0926\u094d\u0927\u093f \u0938\u092e\u093e\u0928 \u0939\u0948 - \u0928\u093f\u0930\u092a\u0947\u0915\u094d\u0937 \u0914\u0938\u0924 \u0935\u0943\u0926\u094d\u0927\u093f 0.9%, \u092f\u093e\u0928\u0940 \u090f\u0915 \u0939\u091c\u093c\u093e\u0930 \u092e\u0947\u0902 9 \u092d\u093e\u0917\u0964 \u0939\u092e \u0938\u0939\u092e\u0924 \u0939\u0948\u0902\u0964<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u092f\u0926\u093f \u0915\u094b\u0908 \u0907\u0938 \u0906\u0927\u093e\u0930 \u0915\u094b \u0938\u094d\u0935\u0940\u0915\u093e\u0930 \u0915\u0930\u0924\u093e \u0939\u0948 \u0915\u093f \u091f\u094d\u0930\u0902\u0915\u0947\u091f\u0947\u0921 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u092e\u0947\u0902 9 \u092d\u093e\u0917 \u092a\u094d\u0930\u0924\u093f \u0939\u091c\u093e\u0930 \u0915\u0947 \u0915\u094d\u0930\u092e \u092e\u0947\u0902 \u090f\u0915 \u091b\u094b\u091f\u0940 \u0938\u0940 \u0935\u0943\u0926\u094d\u0927\u093f, \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u0932\u093e\u092d \u0915\u0940 \u092d\u0935\u093f\u0937\u094d\u092f\u0935\u093e\u0923\u0940 \u0915\u0930\u0928\u0947 \u0915\u0947 \u0932\u093f\u090f \u0909\u091a\u093f\u0924 \u0930\u0942\u092a \u0938\u0947 \u0938\u0902\u092d\u093e\u0935\u093f\u0924 \u0939\u0948, \u0924\u094b \u092f\u0939 \u092e\u093e\u0928\u0928\u093e \u0909\u091a\u093f\u0924 \u0932\u0917\u0924\u093e \u0939\u0948 \u0915\u093f \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u0932\u093e\u092d \u0906\u0928\u0941\u092a\u093e\u0924\u093f\u0915 \u0930\u0942\u092a \u0938\u0947 \u091b\u094b\u091f\u093e \u0939\u094b\u0917\u093e\u0964<\/strong><\/p>\n\n\n\n<div><a href=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/07\/Vyondys-53-Study-4053-101.png\" class=\"td-modal-image\"><figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"975\" height=\"884\" src=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/07\/Vyondys-53-Study-4053-101.png\" alt=\"\u0935\u094d\u092f\u094b\u0902\u0921\u093f\u0938 53 (\u0917\u094b\u0932\u094b\u0921\u093f\u0930\u0938\u0928) \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u0938\u094d\u0924\u0930\" class=\"wp-image-4115\" title=\"\" srcset=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/07\/Vyondys-53-Study-4053-101.png 975w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/07\/Vyondys-53-Study-4053-101-300x272.png 300w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/07\/Vyondys-53-Study-4053-101-768x696.png 768w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/07\/Vyondys-53-Study-4053-101-13x12.png 13w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/07\/Vyondys-53-Study-4053-101-463x420.png 463w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/07\/Vyondys-53-Study-4053-101-150x136.png 150w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/07\/Vyondys-53-Study-4053-101-696x631.png 696w\" sizes=\"auto, (max-width: 975px) 100vw, 975px\" \/><figcaption class=\"wp-element-caption\">\u0938\u094d\u0930\u094b\u0924: FDA 211970Orig1s000<\/figcaption><\/figure><\/a><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"clinical-effect-of-vyondys-53\">\u0935\u094d\u092f\u094b\u0902\u0921\u093f\u0938 53 \u0915\u093e \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u092a\u094d\u0930\u092d\u093e\u0935<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u0905\u0927\u094d\u092f\u092f\u0928 4053-101 \u0915\u0947 6 \u092e\u093f\u0928\u091f \u0915\u0940 \u092a\u0948\u0926\u0932 \u092f\u093e\u0924\u094d\u0930\u093e \u0915\u0947 \u0906\u0902\u0915\u0921\u093c\u094b\u0902 \u092a\u0930 \u092f\u0939\u093e\u0901 \u091a\u0930\u094d\u091a\u093e \u0928\u0939\u0940\u0902 \u0915\u0940 \u0917\u0908 \u0939\u0948, \u0932\u0947\u0915\u093f\u0928 \u0935\u0947 \u0932\u0917\u092d\u0917 \u0938\u092d\u0940 \u0932\u0921\u093c\u0915\u094b\u0902 \u092e\u0947\u0902 \u0936\u093e\u0930\u0940\u0930\u093f\u0915 \u0915\u093e\u0930\u094d\u092f\u0915\u094d\u0937\u092e\u0924\u093e \u092e\u0947\u0902 \u0915\u094d\u0930\u092e\u093f\u0915 \u0915\u092e\u0940 \u0926\u0930\u094d\u0936\u093e\u0924\u0947 \u0939\u0948\u0902\u0964 \u0907\u0938\u0915\u0947 \u0905\u0932\u093e\u0935\u093e, \u0936\u093e\u0930\u0940\u0930\u093f\u0915 \u092a\u094d\u0930\u0926\u0930\u094d\u0936\u0928 \u0915\u094b \u092c\u0928\u093e\u090f \u0930\u0916\u0928\u0947 \u0914\u0930 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u0909\u0924\u094d\u092a\u093e\u0926\u0928 \u092e\u0947\u0902 \u0915\u092e\u0940 \u0915\u0947 \u092c\u0940\u091a \u0915\u094b\u0908 \u0938\u0902\u092c\u0902\u0927 \u0928\u0939\u0940\u0902 \u0939\u0948, \u091c\u094b \u0906\u0917\u0947 \u092f\u0939 \u0938\u0941\u091d\u093e\u0935 \u0926\u0947\u0924\u093e \u0939\u0948 \u0915\u093f \u092f\u0926\u093f \u0917\u094b\u0932\u094b\u0921\u093f\u0930\u094d\u0938\u0928 \u0915\u093e \u0935\u093e\u0938\u094d\u0924\u0935 \u092e\u0947\u0902 \u0915\u094b\u0908 \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u092a\u094d\u0930\u092d\u093e\u0935 \u0939\u0948, \u0924\u094b \u092a\u094d\u0930\u092d\u093e\u0935 \u0915\u093e \u0906\u0915\u093e\u0930 \u091b\u094b\u091f\u093e \u0939\u0948\u0964<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"serious-side-effects-of-vyondys-53-according-to-the-fda\">FDA \u0915\u0947 \u0905\u0928\u0941\u0938\u093e\u0930, \u0935\u094d\u092f\u094b\u0902\u0921\u093f\u0938 53 \u0915\u0947 \u0917\u0902\u092d\u0940\u0930 \u0926\u0941\u0937\u094d\u092a\u094d\u0930\u092d\u093e\u0935<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u0926\u093f\u0938\u0902\u092c\u0930 2019 \u092e\u0947\u0902, FDA \u0928\u0947 \u090f\u0915\u094d\u0938\u0949\u0928 53 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0915\u0947 \u092a\u094d\u0930\u0924\u093f \u0938\u0902\u0935\u0947\u0926\u0928\u0936\u0940\u0932 \u0921\u0940\u090f\u092e\u0921\u0940 \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f \u092a\u0939\u0932\u0947 \u0932\u0915\u094d\u0937\u093f\u0924 \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u0940\u092f \u0935\u093f\u0915\u0932\u094d\u092a \u0915\u0947 \u0930\u0942\u092a \u092e\u0947\u0902 Sarepta \u0915\u0947 Vyondys 53 \u0915\u094b \u0905\u0927\u093f\u0915\u0943\u0924 \u0915\u093f\u092f\u093e\u0964 \u0939\u093e\u0932\u093e\u0901\u0915\u093f, \u0907\u0938 \u0926\u0935\u093e \u0915\u094b FDA \u0928\u0947 \u091a\u093e\u0930 \u092e\u0939\u0940\u0928\u0947 \u092a\u0939\u0932\u0947 \u090f\u0915 \u0938\u0940\u0906\u0930\u090f\u0932 \u092e\u0947\u0902 \u0905\u0938\u094d\u0935\u0940\u0915\u093e\u0930 \u0915\u0930 \u0926\u093f\u092f\u093e \u0925\u093e, \u091c\u093f\u0938 \u092a\u0930 \u090f\u0932\u093f\u0938 \u0909\u0902\u0917\u0930 \u0928\u0947 \u0939\u0938\u094d\u0924\u093e\u0915\u094d\u0937\u0930 \u0915\u093f\u090f \u0925\u0947, \u091c\u094b \u0909\u0938 \u0938\u092e\u092f \u0938\u0947\u0902\u091f\u0930 \u092b\u0949\u0930 \u092e\u0947\u0921\u093f\u0938\u093f\u0928 \u0907\u0935\u0948\u0932\u094d\u092f\u0942\u090f\u0936\u0928 \u090f\u0902\u0921 \u0930\u093f\u0938\u0930\u094d\u091a \u0915\u0947 \u0921\u094d\u0930\u0917 \u0907\u0935\u0948\u0932\u094d\u092f\u0942\u090f\u0936\u0928 \u0911\u092b\u093f\u0938 \u0915\u0947 \u092a\u094d\u0930\u092e\u0941\u0916 \u0925\u0947\u0964<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA \u0928\u0947 \u0905\u0938\u094d\u0935\u0940\u0915\u0943\u0924\u093f \u0915\u0947 \u0914\u091a\u093f\u0924\u094d\u092f \u092e\u0947\u0902 \u0915\u0939\u093e \u0915\u093f, \u0909\u092a\u091a\u093e\u0930 \u0938\u0947 \u0909\u0924\u094d\u092a\u0928\u094d\u0928 &quot;\u091f\u094d\u0930\u0902\u0915\u0947\u091f\u0947\u0921 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u092e\u0947\u0902 \u092e\u093e\u092e\u0942\u0932\u0940 \u0935\u0943\u0926\u094d\u0927\u093f&quot; \u0915\u094b \u0926\u0947\u0916\u0924\u0947 \u0939\u0941\u090f, \u0935\u094d\u092f\u094b\u0902\u0921\u093f\u0938 53 \u0915\u093e \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u0940\u092f \u092a\u094d\u0930\u092d\u093e\u0935 \u0938\u0902\u092d\u0935\u0924\u0903 &quot;\u0905\u0928\u0941\u092a\u093e\u0924\u093f\u0915 \u0930\u0942\u092a \u0938\u0947 \u091b\u094b\u091f\u093e&quot; \u0939\u094b\u0917\u093e\u0964 \u0909\u0902\u0917\u0930 \u0928\u0947 \u0906\u0917\u0947 \u092c\u0924\u093e\u092f\u093e \u0915\u093f \u0935\u094d\u092f\u094b\u0902\u0921\u093f\u0938 53 \u0926\u094d\u0935\u093e\u0930\u093e \u0932\u0921\u093c\u0915\u094b\u0902 \u092e\u0947\u0902 \u0909\u0924\u094d\u092a\u093e\u0926\u093f\u0924 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u0915\u0940 \u092e\u093e\u0924\u094d\u0930\u093e \u0914\u0930 \u0909\u0928\u0915\u0947 \u0936\u093e\u0930\u0940\u0930\u093f\u0915 \u092a\u094d\u0930\u0926\u0930\u094d\u0936\u0928 \u0915\u0947 \u092c\u0940\u091a &quot;\u0915\u094b\u0908 \u0938\u0902\u092c\u0902\u0927&quot; \u0928\u0939\u0940\u0902 \u0925\u093e, \u0914\u0930 \u091c\u093f\u0928 \u0932\u0921\u093c\u0915\u094b\u0902 \u0915\u0940 \u0926\u0935\u093e \u0932\u0947\u0928\u0947 \u0915\u0947 \u092c\u093e\u0926 \u091c\u093e\u0901\u091a \u0915\u0940 \u0917\u0908, \u0909\u0928\u092e\u0947\u0902 \u0938\u0947 &quot;\u0905\u0928\u093f\u0935\u093e\u0930\u094d\u092f \u0930\u0942\u092a \u0938\u0947 \u0938\u092d\u0940&quot; \u092e\u0947\u0902 \u0936\u093e\u0930\u0940\u0930\u093f\u0915 \u0915\u093e\u0930\u094d\u092f\u0915\u094d\u0937\u092e\u0924\u093e \u092e\u0947\u0902 \u092c\u0922\u093c\u0924\u0940 \u0939\u0941\u0908 \u0915\u092e\u0940 \u0926\u0947\u0916\u0940 \u0917\u0908\u0964<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u092e\u093e\u0928\u094b \u091a\u094b\u091f\u0947\u0902 \u0939\u0940 \u0915\u093e\u092b\u0940 \u0928\u0939\u0940\u0902 \u0925\u0940\u0902, \u0909\u0902\u0917\u0930 \u0928\u0947 \u0938\u0941\u0930\u0915\u094d\u0937\u093e \u0938\u0902\u092c\u0902\u0927\u0940 \u091a\u093f\u0902\u0924\u093e\u0913\u0902 \u0915\u0940 \u090f\u0915 \u0932\u0902\u092c\u0940 \u0938\u0942\u091a\u0940 \u0917\u093f\u0928\u093e\u0908, \u091c\u093f\u0928\u0915\u093e \u0938\u093e\u092e\u0928\u093e \u0935\u093e\u092f\u094b\u0902\u0921\u093f\u0938 53 \u0915\u0947 \u0909\u092a\u092f\u094b\u0917\u0915\u0930\u094d\u0924\u093e\u0913\u0902 \u0915\u094b \u0915\u0930\u0928\u093e \u092a\u0921\u093c\u093e\u0964 \u0907\u0928\u092e\u0947\u0902 &quot;\u0917\u0941\u0930\u094d\u0926\u0947 \u0915\u0940 \u0935\u093f\u0937\u093e\u0915\u094d\u0924\u0924\u093e&quot; \u0914\u0930 &quot;\u0926\u0935\u093e \u0938\u0947 \u091c\u0941\u0921\u093c\u0947 \u0917\u0902\u092d\u0940\u0930 \u0938\u0902\u0915\u094d\u0930\u092e\u0923&quot; \u0936\u093e\u092e\u093f\u0932 \u0925\u0947\u0964 \u0909\u0928\u0915\u093e \u0926\u093e\u0935\u093e \u0939\u0948 \u0915\u093f \u0926\u094b\u0928\u094b\u0902 \u0939\u0940 &quot;\u0918\u093e\u0924\u0915 \u0939\u094b \u0938\u0915\u0924\u0947 \u0939\u0948\u0902&quot;, \u0914\u0930 \u092c\u093e\u0926 \u0935\u093e\u0932\u0947 \u0938\u0902\u0915\u094d\u0930\u092e\u0923 \u0915\u0940 &quot;\u0928\u093f\u0917\u0930\u093e\u0928\u0940 \u0915\u0930\u0928\u093e \u092e\u0941\u0936\u094d\u0915\u093f\u0932 \u092f\u093e \u0905\u0938\u0902\u092d\u0935&quot; \u0939\u0948\u0964<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sarepta \u0915\u0940 \u091c\u0940\u0928 \u0925\u0947\u0930\u0947\u092a\u0940 Elevidys \u0938\u0947 \u091c\u0941\u0921\u093c\u0940 \u0917\u0902\u092d\u0940\u0930 \u092f\u0915\u0943\u0924 \u0935\u093f\u092b\u0932\u0924\u093e \u0938\u0947 \u0939\u0941\u0908 \u0926\u094b \u0939\u093e\u0932\u093f\u092f\u093e \u092e\u094c\u0924\u094b\u0902 \u0915\u094b \u0926\u0947\u0916\u0924\u0947 \u0939\u0941\u090f, \u092f\u0939 \u0926\u0942\u0938\u0930\u0940 \u091a\u0947\u0924\u093e\u0935\u0928\u0940 \u0935\u093f\u0936\u0947\u0937 \u0930\u0942\u092a \u0938\u0947 \u091a\u093f\u0902\u0924\u093e\u091c\u0928\u0915 \u0939\u0948\u0964 \u091c\u0948\u0938\u093e \u0915\u093f \u0909\u0902\u0917\u0930 \u0928\u0947 \u092a\u0924\u094d\u0930 \u092e\u0947\u0902 \u0909\u0932\u094d\u0932\u0947\u0916 \u0915\u093f\u092f\u093e \u0939\u0948, \u0926\u094b\u0928\u094b\u0902 \u0939\u0940 \u0924\u0930\u0940\u0915\u0947 \u092f\u0915\u0943\u0924 \u0915\u094b \u0928\u0941\u0915\u0938\u093e\u0928 \u092a\u0939\u0941\u0901\u091a\u093e\u0928\u0947 \u0935\u093e\u0932\u0947 \u0939\u0948\u0902, \u092d\u0932\u0947 \u0939\u0940 Vyondys 53 \u090f\u0915 \u090f\u0902\u091f\u0940\u0938\u0947\u0902\u0938 \u0911\u0932\u093f\u0917\u094b\u0928\u094d\u092f\u0942\u0915\u094d\u0932\u093f\u092f\u094b\u091f\u093e\u0907\u0921 (ASO) \u0939\u0948, \u0928 \u0915\u093f Elevidys \u091c\u0948\u0938\u0940 \u090f\u0921\u0947\u0928\u094b-\u090f\u0938\u094b\u0938\u093f\u090f\u091f\u0947\u0921 \u0935\u093e\u092f\u0930\u0938 (AAV)-\u0906\u0927\u093e\u0930\u093f\u0924 \u091c\u0940\u0928 \u0925\u0947\u0930\u0947\u092a\u0940\u0964<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0914\u0930 \u092a\u0922\u093c\u0947\u0902<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/07\/Vyondys-53-FDA-Rejection-Letter.pdf\">\u0935\u094d\u092f\u094b\u0902\u0921\u093f\u0938 53 FDA \u0905\u0938\u094d\u0935\u0940\u0915\u0943\u0924\u093f \u092a\u0924\u094d\u0930<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"how-was-vyondys-53-approved\">\u0935\u094d\u092f\u094b\u0902\u0921\u093f\u0938 53 \u0915\u094b \u0915\u0948\u0938\u0947 \u092e\u0902\u091c\u0942\u0930\u0940 \u0926\u0940 \u0917\u0908?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u0938\u0940\u0906\u0930\u090f\u0932 \u092e\u0947\u0902 \u0928\u093f\u092f\u093e\u092e\u0915 \u0926\u094d\u0935\u093e\u0930\u093e \u0909\u0920\u093e\u0908 \u0917\u0908 \u091a\u093f\u0902\u0924\u093e\u0913\u0902 \u0915\u094b \u0926\u0942\u0930 \u0915\u0930\u0928\u0947 \u0915\u0947 \u0932\u093f\u090f, \u0938\u0930\u0947\u092a\u094d\u091f\u093e \u0928\u0947 \u092c\u093e\u0926 \u092e\u0947\u0902 \u090f\u0915 \u0905\u092a\u0940\u0932 \u0926\u093e\u092f\u0930 \u0915\u0940 \u0914\u0930 FDA \u0938\u0947 \u092e\u0941\u0932\u093e\u0915\u093e\u0924 \u0915\u0940\u0964 \u0907\u0938\u0915\u0947 \u092a\u0930\u093f\u0923\u093e\u092e\u0938\u094d\u0935\u0930\u0942\u092a, \u0905\u0902\u0924\u0924\u0903 FDA \u0915\u0947 \u0924\u0924\u094d\u0915\u093e\u0932\u0940\u0928 \u0928\u094d\u092f\u0942 \u0921\u094d\u0930\u0917\u094d\u0938 \u0915\u093e\u0930\u094d\u092f\u093e\u0932\u092f \u0915\u0947 \u092a\u094d\u0930\u092e\u0941\u0916, \u092a\u0940\u091f\u0930 \u0938\u094d\u091f\u0940\u0928, \u091c\u093f\u0928\u094d\u0939\u094b\u0902\u0928\u0947 \u0905\u092a\u094d\u0930\u0948\u0932 \u092e\u0947\u0902 \u090f\u091c\u0947\u0902\u0938\u0940 \u091b\u094b\u0921\u093c \u0926\u0940 \u0925\u0940, \u0928\u0947 \u0935\u093e\u092f\u094b\u0902\u0921\u093f\u0938 53 \u0915\u094b \u092e\u0902\u091c\u093c\u0942\u0930\u0940 \u0926\u0947 \u0926\u0940\u0964<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"pharmaceutical-companies-dont-publish-all-information\">\u0926\u0935\u093e \u0915\u0902\u092a\u0928\u093f\u092f\u093e\u0901 \u0938\u092d\u0940 \u091c\u093e\u0928\u0915\u093e\u0930\u0940 \u092a\u094d\u0930\u0915\u093e\u0936\u093f\u0924 \u0928\u0939\u0940\u0902 \u0915\u0930\u0924\u0940\u0902<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">&quot;\u0915\u093e\u092b\u0940 \u0932\u0902\u092c\u0947 \u0938\u092e\u092f \u0938\u0947, \u0926\u0935\u093e \u0928\u093f\u0930\u094d\u092e\u093e\u0924\u093e FDA \u0915\u094b \u0932\u0947\u0915\u0930 \u0905\u0928\u0941\u092e\u093e\u0928 \u0932\u0917\u093e\u0928\u0947 \u0915\u093e \u0916\u0947\u0932 \u0916\u0947\u0932 \u0930\u0939\u0947 \u0939\u0948\u0902,&quot; FDA \u0915\u092e\u093f\u0936\u094d\u0928\u0930 \u092e\u093e\u0930\u094d\u091f\u0940 \u092e\u0915\u0947\u0930\u0940, \u090f\u092e\u0921\u0940, \u090f\u092e\u092a\u0940\u090f\u091a \u0928\u0947 \u0915\u0939\u093e\u0964 &quot;\u0926\u0935\u093e \u0928\u093f\u0930\u094d\u092e\u093e\u0924\u093e \u0914\u0930 \u092a\u0942\u0902\u091c\u0940 \u092c\u093e\u091c\u093e\u0930 \u0926\u094b\u0928\u094b\u0902 \u0939\u0940 \u092a\u0942\u0930\u094d\u0935\u093e\u0928\u0941\u092e\u093e\u0928 \u091a\u093e\u0939\u0924\u0947 \u0939\u0948\u0902\u0964 \u0907\u0938\u0932\u093f\u090f \u0906\u091c \u0939\u092e \u0909\u0928\u094d\u0939\u0947\u0902 \u092f\u0939 \u092a\u094d\u0930\u0926\u093e\u0928 \u0915\u0930\u0928\u0947 \u0915\u0947 \u090f\u0915 \u0915\u0926\u092e \u0914\u0930 \u0915\u0930\u0940\u092c \u0939\u0948\u0902, \u091c\u093f\u0938\u0915\u093e \u0905\u0902\u0924\u093f\u092e \u0932\u0915\u094d\u0937\u094d\u092f \u092e\u0930\u0940\u091c\u094b\u0902 \u0924\u0915 \u0924\u0947\u091c\u0940 \u0938\u0947 \u0907\u0932\u093e\u091c \u0914\u0930 \u0938\u093e\u0930\u094d\u0925\u0915 \u0909\u092a\u091a\u093e\u0930 \u092a\u0939\u0941\u0901\u091a\u093e\u0928\u093e \u0939\u0948\u0964&quot;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u091a\u0942\u0901\u0915\u093f FDA \u0928\u0947 \u0910\u0924\u093f\u0939\u093e\u0938\u093f\u0915 \u0930\u0942\u092a \u0938\u0947 \u0932\u0902\u092c\u093f\u0924 \u0906\u0935\u0947\u0926\u0928\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f CRL \u092a\u094d\u0930\u0915\u093e\u0936\u093f\u0924 \u0915\u0930\u0928\u0947 \u0938\u0947 \u092a\u0930\u0939\u0947\u091c \u0915\u093f\u092f\u093e \u0939\u0948, \u092a\u094d\u0930\u093e\u092f\u094b\u091c\u0915 \u0905\u0915\u094d\u0938\u0930 \u0905\u092a\u0928\u0947 \u0939\u093f\u0924\u0927\u093e\u0930\u0915\u094b\u0902 \u0914\u0930 \u091c\u0928\u0924\u093e \u0915\u0947 \u0938\u093e\u092e\u0928\u0947 FDA \u0915\u0947 \u0928\u093f\u0930\u094d\u0923\u092f \u0915\u0947 \u092a\u0940\u091b\u0947 \u0915\u0947 \u0924\u0930\u094d\u0915 \u0915\u094b \u0917\u0932\u0924 \u0924\u0930\u0940\u0915\u0947 \u0938\u0947 \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924 \u0915\u0930\u0924\u0947 \u0939\u0948\u0902\u0964 FDA \u0936\u094b\u0927\u0915\u0930\u094d\u0924\u093e\u0913\u0902 \u0926\u094d\u0935\u093e\u0930\u093e \u0915\u093f\u090f \u0917\u090f 2015 \u0915\u0947 \u090f\u0915 \u0935\u093f\u0936\u094d\u0932\u0947\u0937\u0923 \u0915\u0947 \u0905\u0928\u0941\u0938\u093e\u0930, \u092a\u094d\u0930\u093e\u092f\u094b\u091c\u0915\u094b\u0902 \u0928\u0947 \u0938\u093e\u0930\u094d\u0935\u091c\u0928\u093f\u0915 \u0930\u0942\u092a \u0938\u0947 \u092f\u0939 \u0918\u094b\u0937\u0923\u093e \u0915\u0930\u0924\u0947 \u0938\u092e\u092f \u0915\u093f \u0909\u0928\u0915\u0947 \u0906\u0935\u0947\u0926\u0928 \u0915\u094b \u092e\u0902\u091c\u0942\u0930\u0940 \u0928\u0939\u0940\u0902 \u092e\u093f\u0932\u0940 \u0939\u0948, FDA \u0915\u0940 \u0938\u0941\u0930\u0915\u094d\u0937\u093e \u0914\u0930 \u092a\u094d\u0930\u092d\u093e\u0935\u0915\u093e\u0930\u093f\u0924\u093e \u0938\u0902\u092c\u0902\u0927\u0940 \u091a\u093f\u0902\u0924\u093e\u0913\u0902 \u0915\u093e \u0909\u0932\u094d\u0932\u0947\u0916 \u0915\u0930\u0928\u0947 \u0938\u0947 \u092a\u0930\u0939\u0947\u091c \u0915\u093f\u092f\u093e\u0964 \u0907\u0938\u0915\u0947 \u0905\u0932\u093e\u0935\u093e, \u091c\u092c FDA \u0938\u0941\u0930\u0915\u094d\u0937\u093e \u092f\u093e \u092a\u094d\u0930\u092d\u093e\u0935\u0915\u093e\u0930\u093f\u0924\u093e \u0915\u0947 \u0932\u093f\u090f \u0915\u093f\u0938\u0940 \u0928\u090f \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u092a\u0930\u0940\u0915\u094d\u0937\u0923 \u0915\u093e \u0906\u0939\u094d\u0935\u093e\u0928 \u0915\u0930\u0924\u093e \u0939\u0948, \u0924\u094b \u0932\u0917\u092d\u0917 40% \u092c\u093e\u0930 \u0909\u0938 \u092e\u0939\u0924\u094d\u0935\u092a\u0942\u0930\u094d\u0923 \u091c\u093e\u0928\u0915\u093e\u0930\u0940 \u0915\u093e \u0916\u0941\u0932\u093e\u0938\u093e \u0928\u0939\u0940\u0902 \u0915\u093f\u092f\u093e \u091c\u093e\u0924\u093e \u0939\u0948\u0964 \u0917\u0948\u0930-\u0905\u0928\u0941\u092e\u094b\u0926\u0928\u094b\u0902 \u0938\u0947 \u0938\u0940\u0916\u0947 \u0917\u090f \u0938\u092c\u0915 \u092d\u0940 \u0909\u0926\u094d\u092f\u094b\u0917 \u0915\u0947 \u092d\u0940\u0924\u0930 \u0938\u093e\u091d\u093e \u0928\u0939\u0940\u0902 \u0915\u093f\u090f \u091c\u093e\u0924\u0947 \u0939\u0948\u0902, \u091c\u093f\u0938\u0915\u0947 \u0915\u093e\u0930\u0923 \u0915\u0902\u092a\u0928\u093f\u092f\u093e\u0902 \u092c\u093e\u0930-\u092c\u093e\u0930 \u0910\u0938\u0940 \u0939\u0940 \u0917\u0932\u0924\u093f\u092f\u093e\u0901 \u0915\u0930\u0924\u0940 \u0939\u0948\u0902\u0964 \u2013 \u0914\u0930 \u092a\u0922\u093c\u0947\u0902: <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-embraces-radical-transparency-publishing-complete-response-letters\" target=\"_blank\" rel=\"noreferrer noopener\">FDA \u0928\u0947 \u092a\u0942\u0930\u094d\u0923 \u092a\u094d\u0930\u0924\u093f\u0915\u094d\u0930\u093f\u092f\u093e \u092a\u0924\u094d\u0930 \u092a\u094d\u0930\u0915\u093e\u0936\u093f\u0924 \u0915\u0930\u0915\u0947 \u0915\u094d\u0930\u093e\u0902\u0924\u093f\u0915\u093e\u0930\u0940 \u092a\u093e\u0930\u0926\u0930\u094d\u0936\u093f\u0924\u093e \u0905\u092a\u0928\u093e\u0908<\/a> \u2013<\/p>","protected":false},"excerpt":{"rendered":"<p>The Food and Drug Administration published more than 200 letters it sent to companies after their medications were rejected on Thursday, drawing attention to a sometimes overlooked part of the drug review process. One of these rejection letters was sent for Vyondys 53 (golodirsen), a drug manufactured by Sarepta Therapeutics and developed for exon 53 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4127,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[282],"tags":[155,154,328,88,395,65,394],"class_list":["post-4111","post","type-post","status-publish","format-standard","has-post-thumbnail","category-editorials","tag-exon-53","tag-exon-53-skipping","tag-exon-53-skipping-therapy","tag-fda","tag-golodirsen","tag-sarepta","tag-vyondys-53"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts\/4111","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/comments?post=4111"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts\/4111\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/media\/4127"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/media?parent=4111"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/categories?post=4111"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/tags?post=4111"}],"curies":[{"name":"\u0921\u092c\u094d\u0932\u094d\u092f\u0942\u092a\u0940","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}