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Susan Haigney is lead editor of BioPharm International®.
October 13, 2023
The recommended medicines include treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis, menopause symptoms, and diagnostic medicines for characterizing lesions.
The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.
October 12, 2023
The draft guidance document discusses quality considerations for topical ophthalmic drug products.
October 11, 2023
The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.
The program will improve access to adeno-associated virus gene therapy vectors.
October 05, 2023
With the acquisition, Sharp plans on offering fully integrated small-to-medium scale sterile injectable services.