The European Medicines Agency has widened its review of potential suicide risks associated with GLP-1 receptor agonists. The probe, which started July 3, is expected to conclude in November.
An FDA advisory committee voted Wednesday that Ipsen’s fibrodysplasia ossificans progressive candidate palovarotene was effective and the benefits of the drug outweighed its risks.
An independent panel of advisers voted to approve Genentech’s Polivy after internal FDA staff raised concerns regarding the efficacy and risk-benefit profile as a first-line treatment for large B-cell lymphoma.
