Researchers say that the enhanced FDA regulatory authority from the 2017 FDA Amendments Act did not significantly change the time to first agency post...
The Washington Legal Foundation cautions that the Trump administrations ongoing crackdown on direct-to-consumer pharmaceutical advertising is on a col...
FDA approves Italian non-profit Fondazione Telethons BLA for Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskott-Aldrich syndrome.
Childrens Health Defense asks FDA to revoke BLA approvals for all Pfizer and Moderna mRNA Covid-19 vaccines, claiming they do not comply with BLA requ...
FDA qualifies its first artificial intelligence drug development tool, which will be used in metabolic dysfunction-associated steatohepatitis clinical...
FDA posts a final guidance entitled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Pro...
FDA advises the companies manufacturing RSV therapies for infants that the agency is taking a new look at the therapies safety.
FDA warns Saint Paul, MN-based Envoy Medical about Quality System violations in its manufacturing of the Esteem II implantable hearing system.