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July 07, 2025
Article
KalVista's therapy is now approved under the name Ekterly, the first oral therapy for hereditary angioedema, empowering patients with timely, on-demand treatment options.
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.
This FDA News Month in Review provides a round-up of regulatory decisions from June 2025.
The results of the ZENITH trial have encouraged the expansion of sotatercept’s label to patients with prior background therapy.
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
This FDA news recap highlights some of the most notable approvals and actions by the organization in dermatology during Q2 2025.
June 30, 2025
Discover groundbreaking FDA approvals in 2025 that redefine treatment standards, enhance patient care, and address critical public health needs.
The CRL cited deficiencies previously identified at a third-party manufacturing vendor unrelated to OLC, and the Company plans to request a Type A meeting.
June 27, 2025
We spotlight 7 impactful regulatory decisions scheduled to occur during the second half of 2025.
A form of the cytisine regimen, widely used in Eastern Europe for decades, is finally being put in front of US regulators after recently also becoming available in the UK.
