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October 10, 2024
At CPHI Milan, Zaim Gashi, area sales manager of Steriline, discussed the evolution of aseptic processing equipment to stay compliant with current regulations.
June 27, 2024
Diversity Action Plans are now required to be submitted by medical product sponsors after changes governed by the Food and Drug Omnibus Reform Act.
June 25, 2024
This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.
June 06, 2024
Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
June 03, 2024
CGT Catapult and CATTI have developed aligned training standards for the manufacture of advanced therapies.
May 03, 2024
A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.
May 01, 2024
The new draft guidance from FDA provides recommendations for sponsor companies on cell safety testing of human-origin allogeneic cells.
April 30, 2024
Shanghai Henlius Biotech’s first biosimilar has previously received approvals by the European Commission and National Medical Products Administration.
April 25, 2024
The approval, given across three indications, follows a previous approval for second-line use in esophageal squamous cell carcinoma.
April 22, 2024
BioPharm International sat down with Christa Myers of CRB Group and Nadiyra Walker Speight of Fujifilm Diosynth Biotechnologies at INTERPHEX 2024 to examine the implementation of Annex 1.