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The Dresden, Germany facility employs about 640 workers.
The oral, selective PI3Kδ inhibitor is approved for children aged 4 to 11 with activated phosphoinositide 3-kinase delta syndrome (APDS), adding to an earlier clearance for individuals aged 12 and older.
In addition to small molecules, the facility will support the production of biologics and mRNA-based therapies.
The FDA asked for updated safety and efficacy data on the oral kinase inhibitor, extending its review by three months to March 3 of next year.
The oral CGRP inhibitor is the first of its class to successfully reduce migraine days in adults with menstrual migraine.
Conference News
Kensington, MD, USA and Munich/Martinsried, Germany, Sept. 11, 2026 (GLOBE NEWSWIRE) -- Kensington, MD, USA, and Munich/Martinsried, Germany, September 11, 2026 – Galimedix Therapeutics, Inc. (“Galime...
FirstWord spoke with University College London’s Adam Ioannou about detailed Phase III CARDIO-TTransform data for AZ and Ionis' eplontersen, and what impact the failed study will have on use of TTR silencers and stabilisers to treat ATTR-CM.
SAN DIEGO--(BUSINESS WIRE)-- Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, today announced the acceptance of an abstract f...
Results from the planned interim analysis of the Phase 3 REZILIENT3 trial of zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion mutation NSCLC to be presented in Presidential Symposiu...
SOUTH SAN FRANCISCO, Calif., Sept. 10, 2026 (GLOBE NEWSWIRE) -- Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company leveraging nose-to-brain neurocircuitry to develop and commerci...
