ascopubs.org

ADAGIO: A Phase IIb, Open-Label, Single-Arm, Multicenter Study Assessing the Efficacy and Safety of Adavosertib (AZD1775) as Treatment for Recurrent or Persistent Uterine ...

Primary Analysis of EPIK-O/ENGOT-ov61: Alpelisib Plus Olaparib Versus Chemotherapy in Platinum-Resistant or Platinum-Refractory High-Grade Serous Ovarian Cancer Without BRCA Mutation Eligible patients ...

Relmada Therapeutics Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications

FDA written feedback supports:- a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS- a randomized vs ...
Morningstar

Praxis Converts Elsunersen Study to Single-Arm Design After FDA Meeting

Praxis Precision Medicines is converting its EMBRAVE3 study of elsunersen for children suffering from a developmental disease into a single-arm study after meeting with the Food and Drug ...
TCTMD

HF Benefits Look Durable in Single-Arm Study of Coronary Sinus Shunt

BOSTON, MA—Patients with heart failure and mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) and elevated left atrial pressures appear to derive lasting benefits from a shunt that diverts ...
Seeking Alpha

Aridis Receives Agreement from the FDA on a Single Confirmatory Phase 3 Study of AR-301 and the Clinical Study Design

“We are particularly gratified to reach concurrence with the FDA on the overall study design, endpoints, and patient populations,” said Aridis CEO Vu Truong. “This provides a clear clinical and ...