FDA approves an expanded age indication for Vertex Pharmaceuticals sickle cell drug Casgevy.
FDA warns 3B Medical about multiple violations in its work manufacturing a software device used with ventilator systems imported from China.
FDA warns AseptiKits it is manufacturing and marketing adulterated and misbranded PALA Your Tears medical devices.
FDA approves PharmaEssentias BESREMi injection pen to treat polycythemia vera.
A new analysis of FDA inspection data suggests pharmaceutical manufacturing facilities in the U.S. received a higher proportion of the agency's most s...
FDA informs Capricor Therapeutics that it has scheduled an advisory committee meeting to review the company's BLA resubmission for deramiocel, an inve...
FDA cites Dr. Reddy's Laboratories in a seven-observation Form 483 following a recent pre-license inspection of its biologics manufacturing facility i...
FDA issues Lantheus a Complete Response Letter for its NDA seeking approval for LNTH-2501 (gallium-68 edotreotide), a positron emission tomography ima...
