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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
Phase 2 DeLLphi-309 study suggests every-three-week and every-four-week regimens may offer patients greater treatment flexibility.(SEOUL, Republic of Korea — Saturday, September 12th, 6:15 p.m. Korea ...
Phase III LONESTAR trial finds adding radiation or surgery after nivolumab plus ipilimumab did not improve overall or progression-free survival.(SEOUL, Republic of Korea — Saturday, September 12th, 6:...
Phase 1b DeLLphi-308 study evaluates an investigational subcutaneous formulation of the bispecific T-cell engager.(SEOUL, Republic of Korea — Saturday, September 12th, 6:15 p.m. Korea Standard Time) -...
(SEOUL, Republic of Korea — Saturday, September 12th 6:15 p.m. Standard Time) — Patients with resectable stage IIB–IIIB non-small cell lung cancer (NSCLC) treated with perioperative atezolizumab plus ...
(SEOUL, Republic of Korea —September 12th, 6:15 p.m. Korea Standard Time) — An investigational EGFR x HER3 antibody-drug conjugate demonstrated promising efficacy with a tolerable safety profile in pa...
