The company said the investment is in response not only to customer demand and a belief in the value of US-based innovation, ...

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

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

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

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how technological advances will impact the ...

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

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

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

Sustainability-by-design in bioprocess development, according to Adam Goldstein, senior director of R&D Collaborations at ...

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

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

The pandemic made it daunting for companies to retain talent and then find it anew, but just as that cloud is lifting and ...