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CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Sarepta investors who were adversely affected by alleged ...
The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation ...
Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...
Two major health agencies are facing leadership reshuffles, with the resignations of the FDA’s Vinay Prasad and NICE’s Dr Sam Roberts.
Niemann-Pick Disease Type C (NPC) is a rare genetic disorder caused by mutations in the NPC1 or NPC2 genes, leading to harmful lipid accumulation in organs like the liver and brain. Symptoms, often ...
A biopharmaceutical research company with ties in Andover has laid off a third of its workforce as one of the industry leaders in gene therapy goes through a “strategic restructuring.” Sarepta ...
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India Today on MSNWhat forced Vinay Prasad to exit top job at US FDA in just 3 months
Indian-origin scientist Vinay Prasad resigned as the FDA's vaccine and gene therapy chief in just three months after backlash ...
But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
Gene Therapy Market Gene therapy market surges on breakthroughs in genome editing, rising chronic & genetic disease cases, regulatory appro ...
A controversial hematologist-oncologist who joined FDA this spring and quickly became its top regulator has left the ...
Hong Kong-based CSPC will receive $120 million from Madrigal under the deal. Elsewhere, Apellis and PTC Therapeutics won FDA ...
The FDA’s top vaccine and gene therapy official resigned amid heightened scrutiny over recent drug approval decisions and ...
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