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.
FDA opens a broad investigation into reports of deaths in adults that may be linked to Covid-19 vaccines after probing pediatric deaths allegedly tied...
Two pharmacist-attorneys (BakerHostetler) urge Congress to strengthen federal restrictions on how senior FDA officials move into private-sector roles,...
