Creative Medical secures FDA clearance for dose escalation in Phase 1/2 trial
Creative Medical Technology Holdings announced that the U.S. Food and Drug Administration has cleared an expanded dose escalation for its ongoing Phase 1/2 trial of StemSpine usin ...
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FDA Accepts RDY & ALVO's Prolia & Xgeva Biosimilar BLA for Review
Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...
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FDA’s Backup LDT Enforcement Method: Specimen Collection Kits
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...