FDA launches effort to review infant formulas
The Food and Drug Administration (FDA) announced a new initiative Tuesday titled “Operation Stork Speed” aimed at reviewing ...
Verve Therapeutics announces FDA clearance of IND application for VERVE-102
Verve Therapeutics (VERV) announced the clearance of its Investigational New Drug application by the U.S. Food and Drug Administration for ...
Pharmaceutical Technology on MSN1d
FDA approves IND application for Everest’s cancer vaccine
EVM14 is the first messenger RNA (mRNA) therapeutic vaccine developed internally by the company to gain this approval. Its ...
Longeveron® Announces Positive Type B Meeting with U.S. FDA Regarding Pathway to BLA for Laromestrocel (Lomecel-BTM) in Alzheimer’s Disease
Planned single, pivotal Phase 2/3 clinical trial, if positive, acceptable for Biological License Application (BLA) submission for Alzheimer’s ...
Kaleido Scope6d
Regulatory Coordinator Toolkit
Sample Study Startup Checklist Use this checklist as a guide when planning startup activities. Note: All startup activities may not appear on the checklist. Revise as appropriate to meet the needs of ...
Kaleido Scope6d
Standard Operating Procedure (SOP) Templates
Good procedures and work instructions provide a way to communicate and apply consistent standards and practices within your organization. SOPs are the mechanism to document those procedures and ...
C&EN5d
Synthesis and In Vitro Profiling of Psilocin Derivatives: Improved Stability and Synthetic Properties
Creative Commons (CC): This is a Creative Commons license. Attribution (BY): Credit must be given to the creator. As interest in using psilocybin therapy for treating mental health disorders ...