When Your Drug Supplier Gets a Warning Letter: What Genzyme Ireland Means for Trial Supply Planning
FDA issued a Warning Letter to Genzyme Ireland on June 22, 2026, over CGMP violations at its Waterford site....
Abbisko, AstraZeneca Begin Phase I/II Trial of Lumipodlin With Osimertinib in EGFR-Mutant NSCLC
Abbisko and AstraZeneca begin Phase I/II trial combining lumipodlin with osimertinib in EGFR-mutant NSCLC patients with high PD-L1 expression.
The Pediatric CNS Immunotherapy Signal That Sponsors Are Underreading
ReMIND's multi-antigen T cell data in 25 pediatric CNS patients points to a regulatory inflection point sponsors haven't mapped...
Tonix Launches Phase 2 HORIZON Trial of TNX-102 SL for Major Depressive Disorder
Tonix launches Phase 2 HORIZON trial of TNX-102 SL for major depressive disorder, testing sleep-first mechanism in 360 adults.
When Your Sponsor Gets Acquired Mid-Trial: The Operational Playbook Sites Need Now
Zymeworks' $929M acquisition of Theravance, whose R&D was already shut down, puts active trial sites in a familiar operational...
Mesoblast Seeks FDA Approval for Rexlemestrocel-L in LVAD Patients
Mesoblast seeks FDA approval for rexlemestrocel-L in LVAD patients, with RMAT and Orphan Drug designations enabling accelerated review of...
The 6-Month RR-TB Trial the FDA Should Be Studying as a Pragmatic Design Blueprint
A NEJM pragmatic trial of a 6-month rifampicin-resistant TB regimen just set a new benchmark for adaptive evidence generation...
TransCon CNP Shows Sustained Lower Limb Alignment Improvement in Achondroplasia at Week 104
TransCon CNP sustained lower limb alignment improvement in achondroplasia through Week 104, with mean tibial-femoral angle reduction of 3.8...
Definium’s Phase 3 LSD Win Is Real. The Fracture It Exposed Is Bigger.
Definium's LSD trial hit p<0.0001 and a $700M raise. But credible voices are asking whether FDA's drug model can...
4DMT Completes 4FRONT-2 Enrollment for 4D-150 Gene Therapy in Wet AMD
4D Molecular Therapeutics completes enrollment in 4FRONT-2, a Phase 3 trial of 4D-150 gene therapy for wet AMD, four...