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May 30, 2024
Bkemv (eculizumab-aeeb) is the first interchangeable biosimilar to Soliris (eculizumab) to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
May 29, 2024
An ordered process describing calculations activities for compounded dosage forms is described.
May 28, 2024
In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.
May 23, 2024
The units are being recalled because of incomplete crimp seals and one complaint of a leaking unit.
May 20, 2024
After a review, the agency concluded there was a possible risk of cancer to those exposed to 17-hydroxyprogesterone caproate in the womb.
May 16, 2024
Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
May 13, 2024
EMA’s CHMP recommended treatments for hemophilia A, colorectal cancer, hypertension, overactive bladder, and metastatic breast cancer.
May 09, 2024
Purna Thakker, founder and CEO of ADPT Solution, discusses common issues that companies face with FDA regulations at CPHI North America.
May 08, 2024
This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
May 06, 2024
Digital transformation is allowing for better handling, analysis, and protection of vast data collection.