The agency’s safety committee found no sufficient evidence of causal relationship between the antibiotic doxycycline and the risk of suicide or suicidal thoughts.
All CGMP requirements, including supporting activities, are critical in aseptic sterile manufacturing to ensure product ...
Edwin Stone, Bernard Sagaert, and Khaled Yamout go behind the headlines to discuss what the ongoing measles outbreak in the ...
The European Medicines Agency (EMA) reported on Nov. 28, 2024 that the European Shortages Monitoring Platform (ESMP) is now ...
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.
The acquisition will provide Roche with access to Poseida’s GMP manufacturing capabilities and R&D portfolio assets, ...
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, ...
Traditional formulations commonly struggle to achieve content uniformity with morphologically challenging active pharmaceutical ingredients (APIs), requiring the use of complicated processes such as ...