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...
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.
FDA accepts for review Replimune's BLA resubmission that is seeking accelerated approval of RP1 (vusolimogene oderparepvec) in combination with nivolu...
Two stakeholders ask for greater specificity in an FDA draft guidance on establishing impurity specifications for antibiotics.
Three stakeholders comment on an FDA request for information on AI-enabled optimization of early-stage clinical trials.
