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Ipsen says it plans to file a regulatory application with FDA for its elafibranor to treat adults with primary biliary cholangitis...[ Price : $8.95]
FDA converts Eisais Alzheimers drug Leqembi from accelerated to traditional approval based on the results of a confirmatory trial ...[ Price : $8.95]
Reed Smith attorneys analyze an FDA draft guidance on the Section 503B wholesaling prohibition.[ Price : $8.95]
FDA issues a complete response letter for a Regeneron BLA for aflibercept 8 mg, citing its review of a third-party filler inspecti...[ Price : $8.95]
Four Sidley Austin attorneys say FDA is planning to issue a notice of proposed rulemaking to assert its authority to regulate labo...[ Price : $8.95]
FDA says SystImmune can start Phase 1 studies of its BL-B01D1 in some lung cancer patients.[ Price : $8.95]
Harvard Medical School researchers find FDA follows advisory committee recommendations 88% of the time, but is relying less on the...