Three candidates emerge as finalists to become the next FDA commissioner, according to an Axios report citing sources familiar with the selection proc...
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 6.
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 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 Sobi a Complete Response Letter on its BLA that is seeking approval of NASP (nanoencapsulated sirolimus plus pegadricase) for treating adul...
FDA issues Lantheus a Complete Response Letter for its NDA seeking approval for LNTH-2501 (gallium-68 edotreotide), a positron emission tomography ima...
The European Commission opens a formal antitrust investigation into whether Sanofi abused its dominant market position by allegedly conducting a misle...
FDA informs Capricor Therapeutics that it has scheduled an advisory committee meeting to review the company's BLA resubmission for deramiocel, an inve...
