FDA Rejects Replimune Skin Cancer Drug Amid Capitol Hill Scrutiny
The FDA rejected Replimune's advanced skin cancer drug, citing flawed trial design. RFK Jr. and Congress clash over the agency's evidentiary standards.
clinical trials
11 articles tagged "clinical trials"
KRAS Inhibitor Daraxonrasib Shows Promise in Pancreatic Cancer
Revolution Medicines' daraxonrasib shows meaningful responses in KRAS-mutant pancreatic cancer in Phase 2 data, marking a breakthrough in a notoriously hard-to-treat disease.
Revolution Medicines Raises $2B After Pancreatic Cancer Trial
Revolution Medicines closed a $2 billion raise after Phase 3 data showed daraxonrasib doubled median overall survival in advanced pancreatic cancer.
FDA Warns Drugmakers Over Missing Clinical Trial Results
The FDA sent letters to 2,200+ companies in 2026 warning of fines for failing to submit clinical trial results to ClinicalTrials.gov.
FDA Pushes Clinical Trial Transparency in 2026
Nearly 30% of clinical trials required to report results never submitted data to ClinicalTrials.gov, prompting FDA enforcement letters in April 2026.
Pancreatic Cancer Pill Doubles Survival in New Trial
Revolution Medicines' daraxonrasib nearly doubled median survival in metastatic pancreatic cancer patients compared to chemotherapy, according to new data.
High-Dose Influenza Vaccine Benefits: Authors' Reply
Authors respond to correspondence questioning FLUNITY-HD1 trial design and whether high-dose influenza vaccine offers clear clinical benefits in older adults.
Sarepta Therapeutics Shares Surge on Rare Disease Drug Data
Sarepta Therapeutics shares rose 20% after releasing early clinical data for two rare muscle-wasting disease candidates, SRP-1001 and SRP-1003.
Pfizer Lyme Vaccine Shows 70% Efficacy But Misses Statistical Goal
Pfizer and Valneva's Lyme disease vaccine reduced infection risk by over 70%, but failed to meet its prespecified statistical threshold in clinical trials.
ARPA-H Develops FDA-Authorized AI Agents for Clinical Use
ARPA-H is advancing FDA-authorized AI clinical tools in 2026, pairing federal research funding with mandatory clinical trial validation and deployment pathways.
By Robert Kim
Oral Obesity Pill Phase 2 Results & Cholesterol Guidelines 2026
Structure Therapeutics reports 16% weight loss in Phase 2 oral GLP-1 trial, plus GSK's Arexvy expansion and new cholesterol guideline updates.