A phase 3 trial of MaaT Pharma’s graft-versus-host disease (GvHD) drug candidate has hit its primary endpoint, positioning ...

The agency affirmed the use of biopsies for biomarker-driven trials but cautioned against optional biopsies that offer little value to the patient or trial.

Tran Le was an engineering student at Stanford University when she tried to enroll in a clinical trial for her chronic ...

PharmaEssentia is looking to expand the reach of its FDA-approved rare blood cancer treatment Besremi to another rare blood ...

PAH is a rare condition in children, but is often fatal if left untreated, and protocols for pediatric patients have not been ...

Veliparib plus temozolomide did not significantly extend overall survival in patients with newly diagnosed, ...

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today published a letter to ...

Percheron Therapeutics' board of directors has written a letter to shareholders following failure of its phase 2b trial.

Researchers have applied AI to every step of the drug development process. But this might not be enough to design safe and ...

More than three years after Novartis’ plan for a speedy approval for intrathecal Zolgensma was thwarted by an FDA requirement ...

Safety concerns Keros observed in a Phase 2 trial triggered a stock selloff for what had been one of the sector’s most successful initial public offerings of the last four years, according to ...

Clinical trials in 2025 will be beset by rising costs and uncertain regulations while also benefiting from new technologies ...