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August 01, 2025
Article
This FDA News Month in Review provides a round-up of regulatory decisions from July 2025.
July 31, 2025
The therapy was originally approved under the name Alhemo for people with hemophilia ages 12 and up without inhibitors.
July 24, 2025
Video
An analysis of data from the LUNA 3 trial indicated the comparative safety and clinical significance of the IWG criteria versus the standard platelet count threshold.
A review of data from an ongoing phase 3 trial indicates the potential for a generalized, prespecified fitusiran treatment for hemophilia A and B.
July 22, 2025
Kuter describes several studies investigating aspects of rilzabrutinib which were presented at the ISTH 2025 Congress.
July 03, 2025
Our recap of the first half of 2025 highlights 5 regulatory updates, 5 trial announcements, and 3 top perspectives in hematology.
July 02, 2025
A review of the 16 novel drugs approved by the US Food and Drug Administration during the first half of 2025, with links to coverage from MJH Life Sciences publications.
A relatively quiet quarter for hematology, punctuated by both successes and failures in clinical trials and a handful of Orphan Drug and Fast Track designations.
July 01, 2025
The FDA distributed several designations and many trials successfully met their endpoints during an eventful June for hematology.
June 30, 2025
An audio recap of the top 5 stories in healthcare news from the week of 06/16-06/22
