FDA converts Eisais Alzheimers drug Leqembi from accelerated to traditional approval based on the results of a confirmatory trial that demonstrated it...
Reed Smith attorneys analyze an FDA draft guidance on the Section 503B wholesaling prohibition.
FDA issues a complete response letter for a Regeneron BLA for aflibercept 8 mg, citing its review of a third-party filler inspection.
Four Sidley Austin attorneys say FDA is planning to issue a notice of proposed rulemaking to assert its authority to regulate laboratory-developed tes...
FDA says SystImmune can start Phase 1 studies of its BL-B01D1 in some lung cancer patients.
Harvard Medical School researchers find FDA follows advisory committee recommendations 88% of the time, but is relying less on them.
FDA releases the form FDA-483 issued following a June inspection at Indias Ipca Laboratories.
