Dyne Therapeutics’ z-rostudirsen Wins Priority Review for Duchenne Muscular Dystrophy
Dyne Therapeutics' z-rostudirsen wins Priority Review for Duchenne muscular dystrophy, compressing FDA evaluation to six months for exon 51...
Glofitamab Plus Englumafusp Alfa: When Phase 1 Data Rewrites the Combination Therapy Playbook
A Nature Medicine phase 1 trial pairs glofitamab with CD19-4-1BBL co-stimulation in r/r B-NHL, producing efficacy signals that challenge...
When the Phase 3 Dies After the Acquisition: The Site-Level Fallout No One Plans For
GSK's Phase 3 termination of camlipixant after its $2B Bellus Health buyout triggers an operational cascade—site deactivation, IRB amendments,...
Roche’s Englumafusp Plus Glofitamab Combination Shows Why Phase 1 Trial Design Is the Real Competitive Moat in Bispecific Oncology
A Nature Medicine Phase 1 trial combining englumafusp alfa and glofitamab in B-cell NHL reveals how rational dose escalation...
Akeso Doses First Patient in AK146D1 Phase II Study for Advanced NSCLC
Akeso doses first patient in AK146D1 Phase II Study for advanced NSCLC, combining dual-target ADC with ivonescimab immunotherapy.
The Blood-Brain Barrier Has Been Breached. Is Clinical Trial Science Ready?
FDA's March 2026 approval of AVLAYAH marks the first BBB-crossing biologic — but CNS trial design, PK monitoring, and...
Arletta Pharma Advances Lybrido for Female Sexual Desire Disorder With FDA Backing
Arletta Pharma's Lybrido for female sexual desire disorder advances with FDA backing for a single-trial Phase 3 pathway.
Ambient AI Is Not Losing Your Trial Data. It’s Quietly Deciding What Counts.
Ambient AI scribes reduce physician burnout—but a Lancet case reveals they systematically drop psychosocial context that drives protocol adherence...
Neurizon Completes NUZ-001 ALS Trial Enrollment, Advances Results to Q2 2027
Neurizon completes NUZ-001 ALS Trial enrollment of 250 patients in five months, with topline results expected in late Q2...
FDA Clears IND for Umoja’s UB-VV400 In Vivo CAR T Therapy
FDA clears IND for Umoja's in vivo CAR T therapy UB-VV400, targeting relapsed B cell malignancies with a single...