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
Ampio Pharma's candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the drug before it will consider a review.