Europe’s 2030 Clinical Trial Targets Are Already Falling Behind — And the Clock Is Ticking
EMA's first 2026 quarterly report shows only 40.5% of EU trials recruiting within 200 days — far below the...
Achieve Life Sciences Presents 52-Week Safety Data for Cytisinicline
Achieve Life Sciences presents 52-week safety data for cytisinicline ahead of June 2026 FDA decision, showing low nausea rates...
Quince’s LAM-001 Shows Functional Gains in Phase 2a PH-ILD Study
LAM-001 Phase 2a study shows 67-meter walk distance gain and improved functional class in PH-ILD patients on background treprostinil...
Alterity’s ATH434 Shows 48% Slowing of Decline in MSA Phase 2 Trial
ATH434 shows 48% slowing of functional decline in MSA Phase 2 trial, with significant improvements in swallowing and iron...
Infex Therapeutics’ RESP-X shows exploratory efficacy signal in Phase IIa bronchiectasis study
RESP-X Phase IIa shows exploratory efficacy signal in bronchiectasis study, with quarterly dosing potential and clean safety profile across...
Roche’s giredestrant shows 30% reduction in breast cancer recurrence in Phase III trial
Roche's giredestrant demonstrated a 30% reduction in breast cancer recurrence or death in the Phase III lidERA trial, positioning...
BioMarin’s Vosoritide Shows 2.33 cm/yr Growth Gain in Hypochondroplasia Trial
BioMarin's vosoritide demonstrated a 2.33 cm/yr growth gain in hypochondroplasia, with statistical significance and arm span improvements in Phase...
Mid-Trial Site Additions Sound Like Progress — The Activation Math Tells a Different Story
NKGen Biotech just added 3 Alzheimer's trial sites across NJ, NY, and FL. Here's what the activation math actually...
Intellia’s CRISPR Submission Is a Regulatory Stress Test the FDA Has Never Faced Before
Intellia's nex-z BLA for ATTR amyloidosis is the FDA's first in vivo CRISPR reckoning—and the agency's gene therapy playbook...
NervGen Prepares RESTORE Phase 3 Trial in Chronic Tetraplegia With NVG-291
NervGen advances RESTORE Phase 3 Trial in chronic tetraplegia with NVG-291, a PTP-sigma inhibitor targeting neural repair without approved...