Federal Register notice: FDA announces the issuance of Emergency Use Authorizations for 22 medical Covid-related medical devices authorized in 2023.
Federal Register notice: FDA makes available a draft guidance entitled Good Manufacturing Practice for Active Pharmaceutical Ingredients (APIs) Used i...
CBER says Lewisburg, TN-based Vitacell Biologics is illegally marketing cellular and exosome products.
FDA releases the form FDA-483 with two inspection observations issued to Columbus, OH-based STAQ Pharma of Ohio.
CBER executives say FDA is aware of a relatively small number of cases in which people treated with CAR-T products developed secondary cancers that ma...
FDA tells Liquidia Corp. that its earlier user fee review action target date of 1/24 will be missed on the companys NDA for Yutrepia (treprostinil) in...
A Sheppard Mullin report describes several FDA issues that life sciences companies can expect to face in 2024.
FDA issues a finalized guidance on updating ANDA labels following revisions to the reference-listed drug label.
