Latest news with #FDA warnings

Bloomberg

Sarepta's Duchenne Therapy Sparked Fears Even Before FDA's Order

By , Gerry Smith, and Rachel Cohrs Zhang Save There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy. Reports of troubles linked to Sarepta's Elevidys treatment for Duchenne muscular dystrophy had been popping up on social media for months — beyond the two deaths the company had already disclosed — but there was little information from the company or the health regulators that widened availability of the drug over objections from its own staff, according to analysts, FDA records and at least one patient advocate.