PharmExec

FDA Removes Two Study Requirement for New Drug Approval Process: Report

FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access U.S News February 18, 2026 ...
Pharmaceutical Commerce

FDA Shifts Toward Single Trial Requirement for New Drug Approvals

A policy change allowing approval of some new drugs based on one adequate and well-controlled study could accelerate ...
ascopubs.org

Eftilagimod Alpha Plus Pembrolizumab in First-Line Metastatic Non–Small Cell Lung Cancer: Results From a PD-L1–Unselected Population in the TACTI-002 Study

Low-Dose Total Skin Electron Beam Radiotherapy in Stage IB-IIB Mycosis Fungoides: Results From the Prospective S-MISR Study Eftilagimod alpha (efti), an antigen-presenting cell (APC) activator, may ...
ascopubs.org

Xevinapant or Placebo Plus Platinum-Based Chemoradiotherapy in Unresected Locally Advanced Squamous Cell Carcinoma of the Head and Neck (TrilynX): A Randomized, Phase III Study

Phase II Dose-Randomized Study of Sunvozertinib in Platinum-Pretreated Non–Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations (WU-KONG1B) Patients with unresected ...