Hosted on MSN

Released FDA Files Show Flawed Drug Approval Process

For decades, the Food and Drug Administration has been notoriously tight-lipped about why it rejects drugs. It has remained all-but-silent even when the agency rejects the advice of its advisory ...
JD Supra

FDA Issues Refuse-to-File Letter for mRNA-based Vaccine BLA

The Food and Drug Administration (FDA) has issued a Refuse-to-File (RTF) letter to Moderna, Inc. regarding its Biologics License Application (BLA) for the investigational mRNA-based influenza vaccine ...