Signal
19 articles covering "clinical-trial"
The FDA has approved Shionogi's ensitrelvir (Xocova) for post-exposure prophylaxis of COVID-19, the first oral antiviral cleared for that indication in the US.
IGNYTE trial data show 83.5% of responders alive at three years; Replimune plans third BLA resubmission after two FDA rejections.
A single infusion of VERVE-102 reduced LDL-C by up to 62% and PCSK9 by up to 88% in a 35-patient trial, with effects sustained up to 18 months.
AstraZeneca's baxdrostat (Baxfendy) became the first aldosterone synthase inhibitor approved in the US on May 18, 2026, giving the estimated 23 million Americans whose blood pressure remains uncontrolled on two or more drugs a new mechanistic option.
Fractyl Health received authorization in the Netherlands to run the world's first clinical trial of an AAV-based GLP-1 gene therapy for type 2 diabetes, targeting patients who cannot sustain daily injections.
Fresh 52-week safety data presented at ATS 2026 reinforce cytisinicline's profile ahead of a June 20 FDA decision that could bring the first new smoking cessation drug to US patients since 2006.
A UK trial of preoperative pembrolizumab for MMR-deficient colorectal cancer shows zero relapses across all 32 patients after nearly three years of follow-up.
The FDA cleared an IND for UHeart, a 10-gene-edited pig heart, opening a single-center phase 1/2/3 trial that will enroll up to two patients with end-stage heart failure before any expansion.
Regenxbio's gene therapy RGX-202 met the primary endpoint of its pivotal Phase III AFFINITY DUCHENNE trial, with 93% of participants reaching the microdystrophin expression threshold.
Low-dose digoxin failed its primary endpoint in 1,001 Dutch heart-failure patients, but a JAMA meta-analysis of DECISION, DIGIT-HF and the 1997 DIG trial published the same day finds digitalis cuts the combined risk of cardiovascular death or first worsening event by 15 percent.
Six-year follow-up from a 16-patient Phase 1 trial of autogene cevumeran shows unprecedented survival rates in one of oncology's deadliest cancers, now entering a global Phase 2 trial.
Prime Medicine is pursuing accelerated approval for PM359, an autologous prime editing therapy that restored immune function in both patients treated for chronic granulomatous disease, marking the first clinical use of prime editing technology.