3Spine, Inc., a medical device company developing total joint replacement for the lumbar spine, announced FDA Investigational Device Exemption (IDE) approval for their US pivotal clinical trial. The company previously completed contracting and site initiation at 16 US centers for a prospective real-world evidence (RWE) fusion study, which has been enrolling since May 2021. As… Continue reading 3Spine, Inc. Announces IDE Approval
Tag: FDA Investigational
Ceruvia Lifesciences Submits FDA Investigational New Drug Application for NYPRG-101 Migraine Prevention Program
Ceruvia Lifesciences, a leading neurotransformational medicine biopharmaceutical company today announced the submission of an IND application to begin a Phase 1, single center, randomized, double blind, placebo controlled, single ascending dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NYPRG-101 (2-bromo-D-lysergic acid diethylamide) in healthy adult participants. Also Read: Sonivie Receives Ide Approval… Continue reading Ceruvia Lifesciences Submits FDA Investigational New Drug Application for NYPRG-101 Migraine Prevention Program