FDA guidance expands cancer trial eligibility to include patients with ECOG PS 2, reshaping enrollment models and operational requirements...

Signant Health and Lothar Medical plan integrated respiratory trial device combining spirometry, oscillometry, and FeNO measurement into a single...

Canada's drug agency recommends conditional reimbursement for palopegteriparatide in hypoparathyroidism, pending price negotiation and provincial formulary deci

Roivant presents Phase 2 mosliciguat data for PH-ILD, measuring pulmonary vascular resistance changes over 24 weeks in a 135-patient...

Early trial termination once signaled collapse. Now it signals design sophistication, and regulators, sponsors, and CROs need a new...

AI Agents in Clinical Trials require human review before data commits to clinical databases, balancing automation with regulatory accountability.

Intellia secures $400M credit facility to fund the NTLA-2002 HAE trial through completion, avoiding shareholder dilution from equity offerings.

Tarsus Pharmaceuticals acquires gildeuretinol for Stargardt disease, an oral drug in Phase 3 development with FDA breakthrough therapy designation.

Inhibrx releases Phase 2 primary endpoint data for INBRX-106 in head and neck cancer, testing hexavalent OX40 agonist plus...

Pelacarsen fails to meet primary endpoint in Phase 3 Lp(a) trial, raising questions about biomarker-outcome relationships in cardiovascular drug...