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 ...

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

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

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 ...

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

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

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

The pharma industry is focused on strengthening its foundation, embracing innovation, and future-proofing its path forward.

Donald Ingber, MD, PhD; Miguel Forte, MD, PhD; Ali Pashazadeh, MRCS, MBA; and Adam Inche, PhD, MBA go behind the headlines to ...

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

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance ...