Through this acquisition, the German CDMO expands its global network and adds aseptic fill/finish and lyophilization expertise to its sterile manufacturing capabilities.

Elizabeth Hickman (Chief Business Officer, AustinPx) explains the company's approach to improving bioavailability, ...

Brian Feth and Jonathan Grinstein go behind the headlines to discuss the impact of a Republican administration on Federal ...

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification ...

CDER Director Patrizia Cavazzoni and CBER Director Peter Marks provided an update on the rare disease innovation hub in a new FDA Voices blog post.

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification ...

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification ...

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification ...

Pharmaceutical Technology® caught up with Brittany Hayes, PhD, Highly Potent & Oncology Platform Director at CordenPharma, ...

Traditional formulations commonly struggle to achieve content uniformity with morphologically challenging active pharmaceutical ingredients (APIs), requiring the use of complicated processes such as ...

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification ...

FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.