FDA accepts for review Replimune's BLA resubmission that is seeking accelerated approval of RP1 (vusolimogene oderparepvec) in combination with nivolu...
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...
Two stakeholders ask for greater specificity in an FDA draft guidance on establishing impurity specifications for antibiotics.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.
FDA sends an untitled letter to Pinnacle Biologics, citing promotional videos for cancer therapy Photofrin (porfimer sodium).
FDA approves Gilead Sciences Trodelvy (sacituzumab govitecan-hziy) for first-line treatment of adults with unresectable locally advanced or metastatic...
FDA says it will not accept medical device test data generated by CCIC Huatongwei International Inspection in China because the agency has found sever...
