NurExone Plans Small-Scale of ExoPTEN Clinical Manufacturing in Preparation for FUTURE First in Human USE Pathways

Subject to TSX Venture Exchange (“ TSXV ”) approval, NurExone has engaged Russo Partners LLC, a New York–based strategic ...
Med Device Online

Unpacking The EU's Mutual Recognition Agreements For Pharma

MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.
Medical Design & Outsourcing

ten23 health QC labs in Basel and Visp gain FDA approval

NEWS RELEASE: ten23 health QC lab to support commercial product testing for U.S. customer following FDA approvals Basel, Switzerland — ten23 health, the ten23 health says its Basel and Visp QC ...
BioSpace

Accelerating Timelines and Reducing Cost in Early Clinical Drug Development With ICON’s Accelerated Pharmaceutical Solutions

Innovation drives speed in early phase drug development. ICON’s Accelerated Pharmaceutical Solutions integrate advanced ...

FDA approves Omisirge(R) as First Approved Cell Therapy to Treat Severe Aplastic Anemia

Study demonstrated early and sustained hematopoietic recovery and transfusion independence Omisirge is a new and novel transplant option for patients with SAA Additional manufacturing capacity for ...
Morningstar

Akadeum Life Sciences Announces Drug Master File Submission to the US FDA for GMP Microbubble Cell Separation

Akadeum has been successfully customer-audited per US and EU GMP standards, and the products meet endotoxin, sterility, and viral requirements per USP and ICH standards. As expected for raw materials ...
live.euronext

SoftOx Solutions AS: GMP Drug Substance Successfully Manufactured – Key Milestone for CF and EDF Clinical Programs

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