Sanofi and Regeneron should hear from the FDA in the autumn whether it will approve their blockbuster immunology drug Dupixent as a therapy for rare skin disease prurigo nodularis (PN).
Shares in US biotech Nymox Pharma have plunged after the company announced the FDA had refused to accept its marketing application for its drug candidate for benign prostatic hyperplasia (B
Companies trying to bring digital therapeutic (DTx) products through development and into the market have been navigating in largely uncharted waters for years.
The FDA has delivered a blow to UCB's late-stage pipeline, after saying it is unable to approve its latecomer IL-17 inhibitor bimekizumab for moderate-to-severe plaque psoriasis.
The FDA has declined to approve two more cancer therapies developed by drugmakers based in China, in what may be further evidence of a tough line taken by the regulator for drugs tested out
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.