MarketWatch

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 ...
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 ...
The Manila Times

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

Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology and central nervous system conditions. Its lead candidates, NDV-01 and ...
Medscape

FDA Questions Value of Single-Arm Studies for Cancer Approvals

The US Food and Drug Administration’s (FDA’s) approval decision about a new treatment for non–muscle invasive bladder cancer (NMIBC) hinges on whether a single-armed trial can be trusted to adequately ...