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Drug Approval Articles & Analysis: This-Year
2 news found
Watertown, MA - June 29, 2025 - Biopharma PEG, a leading innovator in high-quality polyethylene glycol (PEG) derivatives, today announced it has successfully obtained Drug Master File (DMF) approval from the U.S. Food and Drug Administration (FDA) for its self-developed HZ-PEG-HZ (1K) product. ...
Proregulations is familiar with the MAA approval process, provides detailed interpretation and advice on EU drugs regulations, and develops application strategies for specific products and needs. ...