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Specifically, the FDAs decision not to include these GLP-1s on the bulk compounding list would not be expected to affect their use by 503A pharmacies

"This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America's leadership in developing innovative medicines." - Stphane Bancel, chief executive officer of Moderna Moderna stated in its announcement that the RTF letter contradicts prior written guidance from CBER

In some cases, companies are signing deals to secure exclusive rights to a particular drug with an upfront payment, followed by a series of additional investments linked to development, regulatory and sales milestones