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.
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...
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...
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...
Genmab’s Epcoritamab Plus Lenalidomide Meets Phase 3 Goal in Relapsed DLBCL
Genmab's epcoritamab plus lenalidomide achieved a 60% risk reduction in Phase 3 relapsed DLBCL trial, beating standard chemotherapy.
FDA Approves Roflumilast Cream for Plaque Psoriasis in Children Age 2+
FDA approves roflumilast cream for plaque psoriasis in children as young as age 2, offering a steroid-free topical option...
Ipsen Acquires Kartos Therapeutics for $450M to Develop Navtemadlin for Myelofibrosis
Ipsen acquires Kartos for navtemadlin for myelofibrosis, an MDM2 inhibitor designed to help ruxolitinib non-responders. Phase III data expected...
Infigratinib Shows +2.1 cm/year Height Gain in Achondroplasia Trial
Infigratinib achondroplasia trial shows 2.1 cm/year height gain over placebo, with first-ever statistically significant body proportionality improvements in Pha
Medicenna’s MDNA11 Shows 30-40% Response Rates in Checkpoint-Resistant Cancers
Medicenna's MDNA11 shows 30-40% response rates in checkpoint-resistant cancers, with Phase 1/2 data expected in Q4 2026.
J&J presents nipocalimab data showing benefits in early-stage myasthenia gravis
J&J's nipocalimab showed significant functional improvements in early-stage myasthenia gravis patients, with benefits sustained through infections.