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

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

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 ...

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

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 ...

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 ...

The "cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA (Nov 13, 2025)" training has been added to ResearchAndMarkets.com's offering. cGMP or current good manufacturing practices are ...

MILPITAS, Calif.--(BUSINESS WIRE)--Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II ...

Cell and extracellular vesicle (EV)-based therapies represent a promising frontier in regenerative medicine and immunotherapy. However, their clinical translation is often constrained by the ...

Understanding the nuances is crucial in determining the regulatory submission pathway, data requirements, and even post-approval compliance expectations. Once a product is confirmed as a combination ...

WUXI, China, Aug. 5, 2025 /PRNewswire/ -- WuXi XDC Cayman Inc. ("WuXi XDC", stock code: 2268.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) focused on the ...