The FDA has declined to approve Vanda Pharma's tradipitant for delayed gastric emptying (gastroparesis), prompting a furious response from the company.
Pharma giant AbbVie has been taken to task by the FDA for running an ad for one of its migraine drugs, featuring tennis star Serena Williams, which the agency says overstates its efficacy.<
At the start of the year, there had been no new therapies for rare cholestatic liver disease primary biliary cholangitis (PBC) in the US for almost a decade.
The journal Psychopharmacology has retracted three articles about MDMA-assisted psychotherapy, shortly after the FDA rejected approval of Lykos Therapeutics' therapy for post-traumatic stre
Novo Nordisk's anti-TFPI antibody concizumab has been backed for approval in the EU as a once-daily drug to prevent bleeding episodes in people with haemophilia.