The API is, one might say, the most important element in a pharmaceutical product. Poor-quality APIs that do not meet potency ...

Calquence (acalabrutinib) plus bendamustine and rituximab reduced risk for disease progression or death by 27% compared with ...

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Scientific, economic, and practical factors should be considered when choosing between the frozen state and lyophilization.

Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations ...

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the ...

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how geopolitical instability in Europe, and ...

BioPharm International® sat down with Noah Kopcho, field application scientist at Gyros Protein Technologies, to talk about ...

As therapeutic modalities evolve, so do the challenges and methodologies associated with maintaining and verifying cleanroom ...

FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.

While global harmonization exists, there are still differences between the US and European GMP requirements that ...

The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for ...