New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported to federal regulators, ...
The London-based company said its in-space microgravity crystallization process could enable cancer treatment to be delivered ...
Based on FDA Office of Generic Drugs guidance previously announced, NRx has transmitted an initial GMP manufacturing order to its US-based manufacturer. NRx has completed confirmatory GMP audits of ...
Advancements in drug manufacturing technologies are reshaping global regulatory frameworks. This shift is largely driven by the integration of artificial intelligence (AI)-powered models, cloud-based ...
SHANGHAI, SHANGHAI, CHINA, April 30, 2026 /EINPresswire.com/ -- In today’s life sciences industry, moving a drug ...
From the moment we could look up to the skies, humanity has dreamt of what’s up there. And once we got there, how could we master it? And now that we’re there all the time, how can we use it? In 2025, ...
The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers and compounders for ...
Key market opportunities in the CDMO for formulations sector include increasing demand for custom peptide synthesis, ...
Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...
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