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.
Teva's long haul to a turnaround of its business has been dealt a blow by the FDA, which has just declined to approve the company's long-acting formulation of schizophrenia drug risperidone