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FDA accepts for review Replimune's BLA resubmission that is seeking accelerated approval of RP1 (vusolimogene oderparepvec) in com...[ 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]
Two stakeholders ask for greater specificity in an FDA draft guidance on establishing impurity specifications for antibiotics.[ Price : $8.95]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).[ Price : $8.95]
FDA approves Gilead Sciences Trodelvy (sacituzumab govitecan-hziy) for first-line treatment of adults with unresectable locally ad...[ Price : $8.95]
FDA says it will not accept medical device test data generated by CCIC Huatongwei International Inspection in China because the ag...[ Price : $8.95]
Speaking at the BIO 2026 convention, former FDAers criticize the informal way in which agency policy was made and announced under ...