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 ...
Alvotech and Dr. Reddy’s gets FDA nod for Biologic License Application for AVT03
Dr. Reddy’s Laboratories (RDY) and Alvotech (ALVO) announced that the U.S. FDA has accepted a Biologic License Application submission for AVT03. Read more here.
PEP-Therapy receives FDA Orphan Drug Designation for PEP-010 for treatment of Pancreatic Cancer
Therapy receives FDA Orphan Drug Designation for PEP-010for treatment of Pancreatic CancerParis (France), March 17, 2025 – ...
Medical Device Network on MSN6d
FDA approves early feasibility study of Valcare’s transcatheter device
The US Food and Drug Administration (FDA) has granted approval for Valcare Medical’s investigational device exemption application, allowing it to begin an early feasibility study of its transcatheter ...
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Scientist’s Study Led FDA to Ban Red No. 3 Food Dye. Yet He Says It Is Safe
Joseph Borzelleca published a study on the food coloring Red No. 3. The FDA cited his work when banning the additive in ...