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.
FDA issues Sobi a Complete Response Letter on its BLA that is seeking approval of NASP (nanoencapsulated sirolimus plus pegadricase) for treating adul...
The European Commission opens a formal antitrust investigation into whether Sanofi abused its dominant market position by allegedly conducting a misle...
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...
