In an unusual move, United Therapeutics has filed a lawsuit against the FDA that claims the regulator is sidestepping established norms in allowing rival Liquidia to file
Fast approaching the end of its patent life, Roche and Novartis’ Xolair is going out with a bang, picking up a new approval as the first and only drug therapy for people w
AstraZeneca’s Tagrisso can be used alongside chemotherapy as a frontline therapy for EGFR-positive non-small cell lung cancer (NSCLC), according to the FDA, consolidating
MSD’s checkpoint inhibitor Keytruda has been cleared by the FDA for use in newly diagnosed cervical cancer patients with less severe disease, becoming the first anti-PD-1/
The FDA has opened a comment period, extending until the end of the month, that is seeking information on how digital health technologies (DHTs) might be deployed to help
The death of a young boy with Duchenne muscular dystrophy (DMD) who was treated with Pfizer’s experimental gene therapy in a phase 2 trial has prompted the company to paus
It’s 2024, and in most clinical trials, data is still being moved from the EHR to the EDC manually – with employees reading data from one screen and typing it onto another.