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FDA cites Dr. Reddy's Laboratories in a seven-observation Form 483 following a recent pre-license inspection of its biologics manu...[ Price : $8.95]
FDA issues Lantheus a Complete Response Letter for its NDA seeking approval for LNTH-2501 (gallium-68 edotreotide), a positron emi...[ Price : $8.95]
Three candidates emerge as finalists to become the next FDA commissioner, according to an Axios report citing sources familiar wit...[ Price : $8.95]
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Mo...[ Price : $8.95]
FDA accepts for review Replimune's BLA resubmission that is seeking accelerated approval of RP1 (vusolimogene oderparepvec) in com...[ Price : $8.95]
Two stakeholders ask for greater specificity in an FDA draft guidance on establishing impurity specifications for antibiotics.[ Price : $8.95]
Three stakeholders comment on an FDA request for information on AI-enabled optimization of early-stage clinical trials.[ Price : $8.95]
FDA sends an untitled letter to Pinnacle Biologics, citing promotional videos for cancer therapy Photofrin (porfimer sodium).