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FDA says it is working with additional manufacturers of hemodialysis and peritoneal dialysis systems to determine the potential ri...[ Price : $8.95]
FDA grants Neuromod Devices a de novo request to market Lenire, the first bimodal neuromodulation device for treating tinnitus.[ Price : $8.95]
Aclaris Therapeutics says a Phase 2 clinical study investigating the efficacy and safety of zunsemetinib in treating hidradenitis ...[ Price : $8.95]
The Association for Accessible Medicines urges FDA to continue to revise a draft guidance on pre-submission facility correspondenc...[ Price : $8.95]
FDA accepts for review a Regeneron Pharmaceuticals supplemental BLA for Dupixent (dupilumab) for treating adults and adolescents a...[ Price : $8.95]
The National Cancer Institute raises concerns about an FDA guidance that requires studies of oncologic investigational agents to e...[ Price : $8.95]
FDA accepts for priority review an Eisai and Biogen supplemental BLA for Leqembi (lecanemab-irmb) 100 mg/mL injection that is inte...[ Price : $8.95]
Lawyers from Troutman Pepper say that two recent medical product cases could be a harbinger of more Department of Justice deferred...